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1、F-1 1 tm2415654-12_f1.htm F-1TABLE OF CONTENTSAs filed with the Securities and Exchange Commission on December 27,2024Registration No.333-UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington,D.C.20549 FORM F-1REGISTRATION STATEMENTUNDERTHE SECURITIES ACT OF 1933 ASCENTAGE PHARMA GROUP INTERNATI

2、ONAL(Exact name of Registrant as specified in its charter)Cayman Islands(State or Other Jurisdiction ofIncorporation or Organization)2834(Primary Standard IndustrialClassification Code Number)Not Applicable(I.R.S.EmployerIdentification Number)68 Xinqing RoadSuzhou Industrial ParkSuzhou,JiangsuChina+

3、86-512-85557777(Address,including zip code,and telephone number,including area code,of Registrants principal executive offices)Not Applicable(Translation of Registrants name into English)Ascentage Pharma Group Inc.700 King Farm Blvd,Suite 510Rockville,Maryland 20850(301)291-5658(Name,address,includi

4、ng zip code,and telephone number,including area code,of agent for service)Copies to:Steven V.BernardMegan J.BaierJennifer FangDavid G.SharonWilson Sonsini Goodrich&RosatiProfessional Corporation1301 Avenue of the Americas,40 FloorNew York,New York 10019+1 212-999-5800 Weiheng ChenWinfield LauWilson

5、Sonsini Goodrich&RosatiProfessional CorporationSuite 1509,15/F Jardine House1 Connaught Place CentralHong Kong+852 3972-4955 Xuelin WangYasin KeshvargarDavis Polk&Wardwell LLP10F,The Hong Kong Club Building3A Chater RoadHong KongChina+852 2533-3300 Approximate date of commencement of proposed sale t

6、o the public:As soon as practicable after the effective date of thisregistration statement.If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415under the Securities Act of 1933,check the following box.If this Form is filed to r

7、egister additional securities for an offering pursuant to Rule 462(b)under the Securities Act,check thefollowing box and list the Securities Act registration statement number of the earlier effective registration statement for the sameoffering.If this Form is a post-effective amendment filed pursuan

8、t to Rule 462(c)under the Securities Act,check the following box and listthe Securities Act registration statement number of the earlier effective registration statement for the same offering.If this Form is a post-effective amendment filed pursuant to Rule 462(d)under the Securities Act,check the f

9、ollowing box and listthe Securities Act registration statement number of the earlier effective registration statement for the same offering.Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of1933.Emerging growth company If an em

10、erging growth company that prepares its financial statements in accordance with U.S.GAAP,indicate by check mark ifthe registrant has elected not to use the extended transition period for complying with any new or revised financial accountingstandards provided pursuant to Section 7(a)(2)(B)of the Sec

11、urities Act.The registrant hereby amends this registration statement on such date or dates as may be necessary to delay itseffective date until the registrant shall file a further amendment which specifically states that this registration statementshall thereafter become effective in accordance with

12、 Section 8(a)of the Securities Act of 1933 or until the registrationstatement shall thereafter become effective on such date as the Securities and Exchange Commission,acting pursuantto said Section 8(a),may determine.thTABLE OF CONTENTSPRELIMINARY PROSPECTUS(Subject to Completion)Issued,2025American

13、 depositary sharesAscentage Pharma Group InternationalRepresenting ordinary shares Ascentage Pharma Group International,or Ascentage Pharma,is offering American depositaryshares,or ADSs.This is our initial public offering in the United States,and no public market currently exists forthe ADSs.Our ord

14、inary shares,par value US$0.0001 per share,have been listed on The Stock Exchange of Hong KongLimited,or the HKEx,since October 28,2019 under the stock code“6855”.On,2025,the closingsale price of our ordinary shares on the HKEx was HK$per ordinary share,equivalent to a price ofUS$per ADS,assuming an

15、 exchange rate of US$1.00 to HK$.The initial public offering price ofthe ADSs will be determined through negotiations between us and the underwriters,and will be based on thetrading price of our ordinary shares on the HKEx prior to the pricing of the ADSs as well as prevailing marketconditions and o

16、ther factors described in the“Underwriting”section beginning on page 313 of this prospectus.Each ADS represents of our ordinary shares.We have applied to list the ADSs on the Nasdaq Global Market,or Nasdaq,under the symbol“AAPG.”Application will be made to the HKEx for the listing of the ordinary sh

17、ares represented by the ADSs we areoffering,and we expect to obtain the approval of the HKEx before the ordinary shares are issued upon theclosing of the offering.The offering is contingent upon final approval of the listing of the ADSs on Nasdaq.Unless otherwise indicated or the context otherwise r

18、equires,references in this prospectus to“AscentagePharma”are to Ascentage Pharma Group International,our Cayman Islands exempted company,andreferences in this prospectus to“we,”“us,”“our company”and“our”are to Ascentage Pharma GroupInternational and its subsidiaries,including Jiangsu Ascentage Pharm

19、a Co.,Ltd.,Shanghai Centagen Bio Co.,Ltd.and Suzhou Yasheng Pharmaceutical Co.,Ltd.and its subsidiaries,which we refer to collectively as ourPRC subsidiaries.Ascentage Pharma is not a Chinese operating company but rather a Cayman Islands exempted company thatconducts operations in multiple countries

20、,including the Peoples Republic of China,or PRC,and the UnitedStates through its subsidiaries,including Suzhou Ascentage Pharmaceutical Co.,Ltd,a limited liabilitycompany incorporated in the PRC,Guangzhou Healthquest Pharma Co.,Ltd.,a limited liability companyincorporated in the PRC,Shenghe Inno Bio

21、,a limited liability company incorporated in the PRC,ShanghaiCentagen Bio Co.,Ltd.,a limited liability company incorporated in the PRC,and Ascentage Pharma GroupInc.,a corporation incorporated in Delaware.Our operations in the PRC are primarily conducted through ourPRC subsidiaries.Under this holdin

22、g company structure,investors in the ADSs are purchasing equity interestsin the Cayman Islands exempted company and obtaining indirect ownership interests in the operatingcompanies,including the PRC operating companies.This holding company structure involves unique risks toinvestors and investors ma

23、y never hold equity interests in our operating companies,including the PRCoperating companies.While we do not operate in an industry that is currently subject to foreign ownershiplimitations in the PRC,PRC regulatory authorities could decide to limit foreign ownership in our industry in thefuture,in

24、 which case there could be a risk that we would be unable to do business in the PRC as we arecurrently structured.In such event,despite our efforts to restructure to comply with the then applicable PRClaws and regulations in order to continue our operations in the PRC,we may experience material chan

25、ges inour business and results of operations,our attempts may prove to be futile due to factors beyond our controland the value of the ADSs you invest in may significantly decline or become worthless.While our currentcorporate structure is not a variable interest entity,or VIE,structure and we have

26、no intention to rely on a VIEstructure in our PRC operations,if the PRC laws and regulations were to change in the future,such changesmay result in adverse changes in our operations,and the ADSs may decline significantly in value.See thesection titled“Risk factorsRisks related to doing business in t

27、he PRC.”A majority of our business and operations is conducted in the PRC through our subsidiaries and thus we areexposed to legal and operational risks associated with operations in the PRC.The PRC government hassignificant authority to exert influence on the ability of a company with operations in

28、 the PRC to conduct itsbusiness.The PRC government exerts significant oversight and discretion over the conduct of our businessand may intervene with or influence our operations as the government deemsThe information in this preliminary prospectus is not complete and may be changed.We may not sell t

29、hese securities until the registrationstatement filed with the Securities and Exchange Commission is effective.The preliminary prospectus is not an offer to sell these securitiesand we are not soliciting offers to buy these securities in any state where the offer or sale is not permitted.TABLE OF CO

30、NTENTSappropriate to further regulatory,political and societal goals.The PRC government has recently published newpolicies that significantly affected certain industries,and we cannot rule out the possibility that it will in the futurerelease regulations or policies regarding our industry that could

31、 result in a material change in our operations or thevalue of our securities,significantly limit or completely hinder our ability to offer or continue to offer securities toinvestors,or cause the value of our securities to significantly decline or become worthless.Recent policy statementsand regulat

32、ory actions by the PRC government,such as those related to human genetic data,biopharmaceutical,cybersecurity,data privacy and cross-border data flows may adversely impact our ability to conduct our business andresearch and development activities,accept foreign investments,or list on a U.S.or other

33、foreign stock exchange,which may cause our securities to be prohibited from trading or to be delisted from Nasdaq or any other U.S.stockexchange.Furthermore,rules and regulations in China can change quickly with little advance notice.The PRC government hasrecently indicated an intent to exert more o

34、versight and control over overseas securities offerings and other capitalmarkets activities and foreign investment in China-based companies.On February 17,2023,the China SecuritiesRegulatory Commission,or the CSRC,promulgated the Trial Administrative Measures of Overseas Securities Offeringand Listi

35、ng by Domestic Companies,or the Trial Measures,and relevant notes and supporting guidelines,whichbecame effective on March 31,2023.Pursuant to the Trial Measures,PRC domestic companies that seek to offer andlist securities in overseas markets,either in direct or indirect means,are required to fulfil

36、l the filing procedure with theCSRC and report relevant information.The Trial Measures provide that if the issuer meets both of the followingcriteria,the overseas securities offering and listing conducted by such issuer will be deemed an indirect overseasoffering by a PRC domestic company:(1)50%or m

37、ore of any of the issuers operating revenue,total profit,totalassets or net assets as documented in its audited consolidated financial statements for the most recent fiscal year isaccounted for by PRC domestic companies;and(2)the main parts of the issuers business activities are conducted inmainland

38、 China,its main place(s)of business are located in mainland China or the majority of senior managementstaff in charge of its business operations and management are PRC citizens or have their usual place(s)of residencelocated in mainland China.Taking into consideration the above-mentioned criteria,th

39、is offering is an indirect offering under the Trial Measures,and we are therefore subject to the filing requirements of the CSRC.We are required to fulfill the filing procedure withthe CSRC in accordance with the Trial Measures and the completion of the filing procedure is a condition to thisofferin

40、g and listing.We confidentially submitted the filing with the CSRC in accordance with the Trial Measures,and inDecember 2024,we received the filing notice from the CSRC in relation to our overseas offering and listing,whichindicates that we have completed the required filing application procedures f

41、or this offering.Any potential action taken by the PRC government to exert more oversight and control over overseas securitiesofferings and other capital markets activities and foreign investment in China-based companies,once taken by thePRC government,could significantly limit or completely hinder

42、our ability to offer or continue to offer securities toinvestors and cause the value of such securities to significantly decline,or,in extreme cases,become worthless.Seethe section titled“Risk factorsRisks related to doing business in the PRC.”In addition,our ability to pay dividendspartially depend

43、s upon dividends paid by our PRC subsidiaries.On December 16,2021,the Public Company Accounting Oversight Board,or the PCAOB,issued its report notifyingthe U.S.Securities and Exchange Commission,or the SEC,of its determination that it was unable to inspect orinvestigate completely registered public

44、accounting firms headquartered in mainland China or Hong Kong,includingour auditor who is headquartered in mainland China.Under the Holding Foreign Companies Accountable Act,asamended by the Consolidated Appropriations Act,2023,or the HFCAA,if the SEC determines that we have filed auditreports issue

45、d by a registered public accounting firm that has not been subject to inspection by the PCAOB for twoconsecutive years,the SEC will prohibit our ordinary shares or ADSs from being traded on a national securitiesexchange or in the over the counter trading market in the United States.The delisting of

46、the ADSs,or the threat oftheir being delisted,may materially and adversely affect the value of your investment.These risks could result in amaterial adverse change in our operations and the value of the ADSs,significantly limit or completely hinder our abilityto offer or continue to offer securities

47、 to investors or cause the value of such securities to significantly decline orbecome worthless.On December 15,2022,the PCAOB issued a report that vacated its December 16,2021determination and removed mainland China and Hong Kong from the list of jurisdictions where it is unable to inspector investi

48、gate completely registered public accounting firms.On December 29,2022,the Consolidated AppropriationsAct,2023 was signed into law,thereby amending the HFCAA(1)to reduce the number of consecutive non-inspection years required for triggering the prohibitions under the HFCAA from three years to two,an

49、d(2)so that anyforeign jurisdiction could be the reason why the PCAOB does not have complete access to inspect or investigate acompanys auditor.As it was originally enacted,the HFCAA applied only if the PCAOBs inability to inspect orinvestigate was due to a position taken by an authority in the fore

50、ign jurisdiction where the relevant public accountingfirm is located.As a result of the Consolidated Appropriations Act,2023 the HFCAA now also applies if the PCAOBsinability to inspect or investigate the relevant accounting firm is due to a position taken by an authority in any foreignjurisdiction.

51、The denying jurisdiction does not need to be where the accounting firm is located.Each year,the PCAOB will determine whether it can inspect and investigate completely audit firms in mainland Chinaand Hong Kong,among other jurisdictions.If the PCAOB were to determine in the future that it no longer h

52、as fullaccess to inspect and investigate completely accounting firms in mainland China and Hong Kong,and if we were tocontinue to use an accounting firm headquartered in one of these jurisdictions to issue an audit report on our financialstatements filed with the SEC,we would be identified as a Comm

53、ission-Identified Issuer following the filing of theannual report on Form 20-F for the relevant fiscal year.There can be no assurance that we would not be identified asa Commission-Identified Issuer for any future fiscal year,and if we were so identified for two consecutive years,wewould become subj

54、ect to the prohibition on trading under the HFCAA.Furthermore,whether the PCAOB will continueto conduct inspectionsCitigroupTABLE OF CONTENTSand investigations completely to its satisfaction of PCAOB-registered public accounting firms headquartered inmainland China and Hong Kong is subject to uncert

55、ainty and depends on a number of factors out of our and ourauditors control,including positions taken by authorities of the PRC or any other foreign jurisdiction.If authorities inthe PRC or another foreign jurisdiction were to take a position at any time in the future that would prevent the PCAOBfro

56、m continuing to inspect or investigate completely registered public accounting firms headquartered in mainlandChina or Hong Kong,and if such lack of inspection were to extend for the requisite period of time under the HFCAA,our securities would be prohibited from being traded on U.S.markets and Nasd

57、aq may determine to delist oursecurities.For more details,see“Risk factorsRisks related to doing business in the PRCThe PCAOB hashistorically been unable to inspect our auditor in relation to their audit work and the inability of the PCAOB to conductinspections over our auditor deprives our investor

58、s of the benefits of such inspections”and“Risk factorsRisksrelated to doing business in the PRCIf the PCAOB is unable to inspect or investigate completely auditors located inChina for two consecutive years,the ADSs will be delisted and our ordinary shares and ADSs will be prohibited fromtrading in t

59、he over-the-counter market under the Holding Foreign Companies Accountable Act.The delisting of theADSs,or the threat of their being delisted,may materially and adversely affect the value of your investment.”Cash is transferred among Ascentage Pharma Group International and our subsidiaries in the f

60、ollowing manner:(1)funds are transferred to Ascentage Pharma Group Internationals subsidiaries from Ascentage Pharma GroupInternational as needed as capital contributions or shareholder loans,as the case may be;and(2)dividends or otherdistributions may be paid by our subsidiaries to Ascentage Pharma

61、 Group International.Our subsidiaries generate andretain cash from operating activities and re-invest in their respective business.In the future,Ascentage Pharma GroupInternationals ability to pay dividends,if any,to its shareholders and to service any debt it may incur will partiallydepend upon div

62、idends paid by PRC subsidiaries.Apart from cash transferred in connection with paid-in capital andshareholder loans,no cash or other assets have been transferred between Ascentage Pharma Group Internationaland a subsidiary,no subsidiaries(including PRC subsidiaries)paid dividends or made other distr

63、ibutions to AscentagePharma Group International,and no dividends or distributions were paid or made to U.S.investors.In the future,cashproceeds raised from financing activities may be transferred by Ascentage Pharma Group International through oursubsidiaries via capital contributions and shareholde

64、r loans,as the case may be,and our subsidiaries may paydividends to their respective shareholders.Payment of dividends is subject to restrictions under the PRC law.Anylimitation on the ability of our PRC subsidiaries to make payments to us could have a material and adverse effect onour ability to co

65、nduct our business.For a detailed discussion of applicable PRC regulations governing distribution ofdividends,see“RegulationPRC regulationsPRC regulations relating to dividend distribution.”In addition,the PRCgovernment imposes regulations on the convertibility of Renminbi into foreign currencies an

66、d the remittance of fundsout of China.Governmental regulations of currency conversion may limit our ability to pay dividends and otherobligations and affect the value of your investment.See“Prospectus summary Cash flows through our organization”and our consolidated financial statements included else

67、where in this prospectus.We currently intend to retain most,ifnot all,of our available funds and any future earnings to operate and expand our business.See“Dividend policy.”We are an“emerging growth company”and a“foreign private issuer”as defined under the U.S.federal securitieslaws,and under applic

68、able SEC rules,we have elected to comply with certain reduced public company reporting anddisclosure requirements.See“Prospectus summaryImplications of being an emerging growth company”and“Prospectus summaryImplications of being a foreign private issuer.”See the section titled“Risk factors”beginning

69、 on page 24 of this prospectus for a discussion of informationthat should be considered before making a decision to purchase the ADSs.Neither the U.S.Securities and Exchange Commission nor any other regulatory body has approved ordisapproved of these securities or passed upon the adequacy or accurac

70、y of this prospectus.Anyrepresentation to the contrary is a criminal offense.Per ADS Total Public offering price US$US$Underwriting discounts and commissions US$US$Proceeds,before expenses,to us US$US$(1)See the section titled“Underwriting”for additional information regarding compensation payable to

71、 the underwriters.We have granted the underwriters an option for a period of 30 days to purchase up to an additional ADSsfrom us at the public offering price,less underwriting discounts and commissions.The underwriters expect to deliver the ADSs against payment in U.S.dollars in New York,New York on

72、 or about,2025.J.P.Morgan Prospectus dated ,2025(1)TABLE OF CONTENTS Table of contents Prospectus summary 1 Risk factors 24 Special note regarding forward-looking statements and industry data 122 Use of proceeds 125 Dividend policy 127 Capitalization 128 Dilution 129 Enforceability of civil liabilit

73、ies 131 Corporate history and structure 133 Price range of our ordinary shares 136 Managements discussion and analysis of financial condition and results of operations 137 Business 155 Regulation 214 Management 243 Principal shareholders 261 Related party transactions 263 Description of share capita

74、l 265 Description of American depositary shares 283 Conversion between ordinary shares and ADSs 301 Shares eligible for future sale 304 Taxation 306 Underwriting 313 Expenses related to this offering 326 Legal matters 327 Experts 328 Where you can find additional information 329 Index to the financi

75、al statements F-1 Neither we nor any of the underwriters have authorized anyone to provide any information or tomake any representations other than those contained in this prospectus or in any free writingprospectuses we have prepared.Neither we nor any of the underwriters take responsibility for,an

76、d can provide no assurance as to the reliability of,any other information that others may giveyou.We are offering to sell,and seeking offers to buy,the ADSs only in jurisdictions where offersand sales are permitted.You should assume that the information appearing in this prospectus istrue,complete a

77、nd accurate only as of the date of this prospectus,regardless of the time ofdelivery of this prospectus or any sale of the ADSs.Our business,financial condition,results ofoperations and prospects may have changed since the date of this prospectus.Neither we nor any of the underwriters has taken any

78、action to permit a public offering of theADSs outside the United States or to permit the possession or distribution of this prospectus orany filed free writing prospectus outside the United States.Persons outside the United Stateswho come into possession of this prospectus or any filed free writing

79、prospectus must informthemselves about and observe any restrictions relating to the offering of the ADSs and thedistribution of the prospectus or any filed free writing prospectus outside the United States.Until,2025(the 25th day after the date of this prospectus),all dealers that buy,sell or trade

80、ADSs,whether or not participating in this offering,may be required to delivera prospectus.This is in addition to the obligation of dealers to deliver a prospectus whenacting as underwriters and with respect to their unsold allotments or subscriptions.TABLE OF CONTENTS Prospectus summaryThis summary

81、highlights selected information contained in greater detail elsewhere in thisprospectus.This summary may not contain all of the information that you should consider beforeinvesting in the ADSs.Before you make an investment decision,you should read the entireprospectus carefully,including the section

82、s titled“Risk factors,”“Special note regarding forward-looking statements and industry data”and“Managements discussion and analysis of financialcondition and results of operations”and our consolidated financial statements and the relatednotes included elsewhere in this prospectus.OverviewWe are a gl

83、obal,integrated biopharmaceutical company engaged in discovering,developing andcommercializing therapies to address global unmet medical needs primarily in hematologicalmalignancies.For more than two decades,our founders and team have leveraged their deepexpertise to develop our proprietary drug dis

84、covery platform to pursue particularly challengingtargets and significant unmet global medical needs.Our lead assets,olverembatinib andlisaftoclax,have global potential to address the major hematological malignancies,includingchronic myeloid leukemia,or CML,acute myeloid leukemia,or AML,chronic lymp

85、hocyticleukemia,or CLL,acute lymphocytic leukemia,or ALL,myelodysplastic syndrome,or MDS,andmultiple myeloma,or MM,which is expected to exceed US$166 billion in aggregate market sizeby 2035,according to the industry report commissioned by us and independently prepared byFrost&Sullivan in connection

86、with this offering,or the F&S Report.We are the only company inthe world with active clinical programs targeting all three known classes of key apoptosisregulators,according to the F&S Report.We have eleven completed or ongoing U.S.and/orinternational registrational trials,including two that are FDA

87、-regulated,for our five key clinical-stage assets.Our first lead asset,olverembatinib,is a novel,next-generation tyrosine kinase inhibitor,or TKI.Olverembatinib is the first and only BCR-ABL1 inhibitor approved in China for the treatment ofpatients with CML in chronic phase,or CML-CP,with T315I muta

88、tions,CML in accelerated phase,or CML-AP,with T315I mutations,and CML-CP that is resistant or intolerant to first and second-generation TKIs.Olverembatinib has demonstrated favorable clinical benefit and tolerability inheavily pretreated patients,particularly ponatinib-or asciminib-failed patients,w

89、ith 52.2%and47.8%of ponatinib-resistant patients achieving complete cytogenic response,or CCyR,andmajor molecular response,or MMR,respectively,and 30.8%and 26.7%of asciminib-resistantpatients achieving CCyR and MMR,respectively.In a five-year follow-up of CML-CP patientstreated with olverembatinib,7

90、3%had remained on the treatment,response rates continued toincrease and the prevalence of treatment-related adverse events,or TRAEs,continued todecrease over such period.Therefore,we believe that olverembatinib,with its real-world patientdata in China,where it is approved,has the potential to be a g

91、lobal therapy for CML.The globalCML market was around US$12.3 billion in 2023 and is expected to grow to US$14.6 billion by2035,according to the F&S Report.We are currently conducting a registrational Phase 3 trial,orPOLARIS-2,of olverembatinib as a monotherapy for CML that is regulated by the U.S.F

92、ood andDrug Administration,or FDA,and subject to the successful completion,we plan to submit a newdrug application,or NDA,to the FDA in 2026.We note that clinical data obtained in China maynot be accepted by the FDA or other foreign regulators to support ongoing or future clinical trials,that olvere

93、mbatinib is approved only in China,and that the outcome of our ongoing clinical trialsis uncertain.We are also pursuing label expansion of olverembatinib in combination withchemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive ALL,orfrontline Ph+ALL,in a registrational P

94、hase 3 trial,or POLARIS-1,and conducting anotherregistrational Phase 3 trial,or POLARIS-3,evaluating olverembatinib as a monotherapy forsuccinate dehydrogenase,or SDH,-deficient gastrointestinal stromal tumor,or GIST.In June2024,we entered into an exclusive option agreement with Takeda Pharmaceutica

95、ls InternationalAG,or Takeda,where we granted Takeda an exclusive option to take an exclusive license(evenas to us and our affiliates)to research,develop,import,export,make,have made,manufacture,have manufactured,use,commercialize and otherwise exploit olverembatinib.Under the terms ofthe option agr

96、eement,we received US$100.0 million from Takeda related to intellectual propertyincome and option payment.We are eligible to be paid an option exercise fee and certainmilestone payments up to approximately US$1.2 billion in the aggregate as well as royalties in arange equal to 12-19%of net sales.See

97、“BusinessLicense,collaboration and other agreementsTakeda exclusive option agreement.”1TABLE OF CONTENTS Our second lead asset,lisaftoclax,is a novel Bcl-2 inhibitor that we are developing for thetreatment of various hematological malignancies.In November 2024,we announced that our NDAfor the treatm

98、ent of relapsed and/or refractory,or r/r,CLL and small lymphocytic lymphoma,orSLL,was accepted with Priority Review designation by the Center of Drug Evaluation,or CDE,ofChinas National Medical Products Administration,or NMPA.According to the F&S Report,thisNDA is the second NDA filed in the world f

99、or a Bcl-2 inhibitor and the first in China for a Bcl-2inhibitor for the treatment of patients with CLL/SLL that are resistant or intolerant to Brutonstyrosine kinase,or BTK,inhibitors.If approved,we plan to launch in China in 2025 and pursueregulatory approvals in multiple countries.The global CLL/

100、SLL market was around US$9.4 billionin 2023 and is expected to grow to US$38.2 billion by 2035,according to the F&S Report.We arealso conducting an FDA-regulated registrational Phase 3 trial,or GLORA,of lisaftoclax incombination with BTK inhibitors for patients with CLL/SLL previously treated with B

101、TK inhibitorsfor more than 12 months with sub-optimal response and pursuing approval of lisaftoclax forfrontline CLL/SLL in a registrational Phase 3 trial,or GLORA-2,of lisaftoclax in combination withacalabrutinib.We believe that lisaftoclax,with its short half-life and potential for patient-friendl

102、yramp-up schedule,can serve as a backbone molecule for combination therapies for manyhematological malignancies,including and beyond CLL/SLL.Therefore,we are also evaluatinglisaftoclax in combination with azacitidine,or AZA,in two registrational Phase 3 trials,GLORA-3and GLORA-4,for the frontline tr

103、eatments of elderly or unfit patients with AML or patients withhigher risk,or HR,myelodysplastic syndrome,or MDS,respectively.Backed by our strong scientific foundation,knowledge of small molecule discovery andcapabilities to conduct clinical trials worldwide,we use state-of-the-art technologies to

104、developinnovative therapeutic agents to treat cancers and address unmet medical needs within thispatient population.Our initial focus has been to leverage our expertise in chemistry to synthesizeinhibitors targeting proteins and pathways that drive the key hallmarks of cancer.Earlier in ourpipeline,

105、we are harnessing our understanding of protein degraders to develop therapies,such asproteolysis targeting chimera molecules,or PROTACs,that target traditionally undruggableproteins that are implicated in oncogenesis.We are empowered by our technical expertise in structure-based drug design and our

106、innovativedrug discovery engine,which allows us to address unmet medical need by targeting key apoptoticpathways and validated tyrosine kinases.These core competencies have allowed us to developsmall molecule and degrader therapies targeted at Bcl-2,Bcl-2/Bcl-xL,IAP and MDM2,in additionto building n

107、ext-generation cell signaling inhibitors(i.e.,BCR-ABL1,ALK,FAK inhibitors)andepigenome-modifying agents(i.e.,EED inhibitor).Beyond our two lead assets,we have severalother clinical-stage assets in U.S.or international clinical trials.Leveraging our robust internal research and development capabiliti

108、es,we have built a portfolio ofglobal intellectual property rights.We have also established collaborations and otherrelationships with leading biotechnology and pharmaceutical companies around the world,including a collaboration and license agreement with Innovent and clinical collaborationagreement

109、s with AstraZeneca,Merck,and Pfizer,and research and development relationshipswith leading research institutions,such as Dana-Farber Cancer Institute,Mayo Clinic,MDAnderson Cancer Center,National Cancer Institute and the University of Michigan.As of June 30,2024,we have a portfolio of more than 350

110、U.S.and foreign patents and more than 182 U.S.andforeign pending patent applications.We have incurred significant net losses in the past,and we intend to continue to investsubstantially in our business.While our net profit was RMB162.8 million(US$22.4 million)for thesix months ended June 30,2024,our

111、 net loss was RMB402.3 million for the six months endedJune 30,2023,and we incurred a net loss of RMB925.7 million(US$127.4 million)andRMB882.9 million for the years ended December 31,2023 and 2022,respectively.As of June 30,2024,we had accumulated losses of RMB5,202.1 million(US$715.8 million).We e

112、xpect tocontinue to incur substantial and increasing losses for the foreseeable future,and we expectthese losses to increase as we continue our development of,and seek regulatory approvals for,our drug candidates(including olverembatinib outside of China),and commercialize such drugcandidates,if app

113、roved.Typically,it takes many years to develop one new drug candidate fromthe time it is discovered to when it is available for treating patients.We may encounterunforeseen expenses,difficulties,complications,delays and other unknown factors that mayadversely affect our business.2TABLE OF CONTENTS O

114、ur pipelineWe have a diversified portfolio that includes several clinical or commercial-stage small moleculedrug assets,five of which are summarized in the following chart:Our pipeline(1)Registrational trials ongoing for CLL/SLL,AML and MDS;Phase 2 trials ongoing for MM.(2)The globe icon as used in

115、this table refers to indications where clinical trials are currently taking place in two or morecountries.The US flag refers to indications for which we have received clearance from the FDA to conduct one or moreclinical trials in the United States.The China flag refers to indications for which we h

116、ave conducted or are currentlyconducting clinical trials only in China.Olverembatinib(HQP1351),our first lead asset,is a novel,next-generation TKI.Olverembatinibis the first and only BCR-ABL1 inhibitor approved in China for patients with CML-CP with T315Imutations,CMP-AP with T315I mutations and CML

117、-CP that is resistant or intolerant to first andsecond-generation TKIs.Olverembatinib was included as an Emerging Treatment Option in the2024 National Comprehensive Cancer Network,or NCCN,guidelines for the management of CMLand received recommendation from the Chinese Society of Clinical Oncology,or

118、 CSCO,guidelinefor the treatment of Ph+ALL.To date,the FDA has granted four orphan drug designations,orODD,to olverembatinib,including for the treatment of CML,ALL,AML and GIST,and fast trackdesignation,or FTD,for the treatment of CML in patients with certain genetic markers who havefailed to respon

119、d to treatments with existing TKIs.Through three registrational Phase 3 trials,weare currently evaluating olverembatinib as a monotherapy and/or in combination with existingtreatments for patients with CML,newly diagnosed patients with frontline Ph+ALL,and patientswith SDH-deficient GIST.Clinical tr

120、ials evaluating olverembatinib are currently taking place inAustralia,Canada,China and the United States.Lisaftoclax(APG-2575),our second lead asset,is a novel Bcl-2 inhibitor that we are developingfor the treatment of various hematological malignancies.To date,the FDA has granted five ODDsto lisaft

121、oclax,including for the treatment of CLL,AML and MM.As of December 31,2023,morethan 800 patients have been treated with lisaftoclax as a monotherapy or combination therapy inclinical trials conducted in United States,Australia,China,and Europe,among whichapproximately 400 patients have CLL/SLL.In No

122、vember 2024,we announced that our NDA wasaccepted with Priority Review designation by the CDE.According to the F&S Report,this NDA isthe second NDA filed in the world for a Bcl-2 inhibitor and the first in China for a BCL-2 inhibitorfor the treatment of patients with CLL/SLL that are resistant or in

123、tolerant to BTK inhibitors.Through four registrational Phase 3 trials,we are currently evaluating lisaftoclax as amonotherapy and/or in combination with existing treatments for patients with CLL/SLL,AML andMDS.We are also evaluating lisaftoclax in ongoing clinical trials for MM and other hematologic

124、almalignancies.Clinical trials evaluating lisaftoclax are currently taking place in Australia,Belgium,Canada,China,France,Germany,Hungary,Japan,Poland,Spain,United Kingdom and theUnited States.3TABLE OF CONTENTS Alrizomadlin(APG-115)is a novel,orally bioavailable,highly selective,small molecule inhi

125、bitorof the mouse double minute 2,or MDM2,homolog.We believe alrizomadlin has potential to treata number of serious rare and orphan diseases and address unmet medical needs in both adultand pediatric indications.To date,the FDA has granted six ODDs and two rare pediatric diseasedesignations,or RPDD,

126、for alrizomadlin.In addition,we plan to pursue FTD and RPDD for ourlate-stage programs for alrizomadlin in malignant peripheral nerve sheath tumors,or MPNST,andadenoid cystic carcinoma,or ACC,for which we reported preliminary Phase 2 results in 2022 and2023,respectively.Clinical trials evaluating al

127、rizomadlin are currently taking place in Australia,China and the United States.Pelcitoclax(APG-1252)is a novel,highly potent,small molecule drug designed to restoreapoptosis through dual inhibition of the Bcl-2 and Bcl-xL proteins.To date,the FDA has grantedone ODD to pelcitoclax for the treatment o

128、f small cell lung cancer,or SCLC.We are currentlyevaluating pelcitoclax in two Phase 1b trials and one Phase 1b/2 trial for the treatment of patientswith non-small cell lung cancer,or NSCLC,neuroendocrine tumors or non-Hodgkins lymphoma,or NHL.As of December 31,2023,at least 203 patients have been t

129、reated with pelcitoclax as amonotherapy or in combination with other antitumor agents across clinical trials conducted in theUnited States,Australia and China.In October 2023,we presented preliminary results from thePhase 1b trial of pelcitoclax in combination with osimertinib in patients with epide

130、rmal growthfactor receptor-mutant,or EGFR-mutant,NSCLC at the 2023 Congress for the European Societyfor Medical Oncology,or ESMO,demonstrating potential therapeutic utility.Clinical trialsevaluating pelcitoclax are currently taking place in Australia,China and the United States.APG-5918 is a potent,

131、orally bioavailable,and highly selective inhibitor of the embryonicectoderm development,or EED,a sub-unit of the Polycomb Repressive Complex 2,or PRC2.APG-5918 is an EED inhibitor with demonstrated potential for treating patients with anemia,including beta-thalassemia and chronic kidney disease,or C

132、KD,-induced anemia.We intend tocomplete an FDA-regulated Phase 1 trial on solid tumors and an NMPA-regulated Phase 1 trialon anemia.Clinical trials evaluating APG-5918 are currently taking place in China and the UnitedStates.Summary of key completed and ongoing clinical trials for olverembatiniband

133、lisaftoclax(1)Registrational Phase 2 trial completed with NDA submission expected in 2024.(2)The globe icon as used in this table refers to trials that are currently taking place in two or more countries.The US flagrefers to trials for which we have received clearance from the FDA to conduct trials

134、in the United States.The China flagrefers to trials for which we have conducted or currently conduct only in China.4TABLE OF CONTENTS Our competitive strengthsWe believe our company is differentiated by several strengths,including:We are a global integrated biopharmaceutical company with discovery,d

135、evelopment,manufacturing and commercialization capabilities,strategically targeting the globalhematological malignancies market,estimated to be US$67.2 billion in 2023 and rising toUS$208.8 billion by 2035;We have two lead FDA-regulated Phase 3 assets that are collectively addressing all six majorhe

136、matological malignancies:Olverembatinib,as a novel next-generation BCR-ABL1 TKI,commercialized in China since2021 with real-world patient data,validating global development and commercializationplans;andLisaftoclax,a novel Bcl-2 inhibitor that we are developing for the treatment of varioushematologi

137、cal malignancies globally,including and beyond CLL/SLL.We have deep expertise and insights in developing small molecule drugs for challenging targetsand high unmet medical need;Our innovative pipelines with global potential and ongoing clinical trials in Australia,Belgium,Canada,China,France,Germany

138、,Hungary,Japan,Poland,Spain,United Kingdom and theUnited States are driven by the proprietary drug discovery platform and technologies such aschemical synthesis and targeted protein degradation;andOur dedicated science-driven international team has complementary knowledge and skillsets,led by vision

139、ary founders working together for more than 20 years.Our strategyOur mission is to become a leading global,fully integrated biopharmaceutical company engagedin discovering,developing and commercializing both first-and best-in-class therapies to addressglobal unmet medical needs primarily in hematolo

140、gical malignancies.To fulfill this mission,weplan to focus on the following strategies:Complete ongoing registrational trials to pursue FDA and other international approval ofolverembatinib;Launch in China in 2025,if approved,and pursue regulatory approval of lisaftoclax in multiplecountries;Progres

141、s other clinical stage assets;Continue building our operations strategically for global markets;andOpportunistically pursue strategic partnerships and collaborations to maximize the potential ofour portfolio.Our teamOur senior management team has significant experience and broad expertise in drug di

142、scoveryand development,clinical trials,FDA and NMPA regulatory matters as well as intellectual propertyand licensing management,and includes:Dajun Yang,M.D.,Ph.D.,our co-founder,chairman of the board and chief executive officer;Shaomeng Wang,Ph.D.,our co-founder,director and chief science advisor;Yi

143、fan Zhai,M.D.,Ph.D.,our chief medical officer;andJeff Kmetz,our chief business officer.Our senior management team is supported by a global team of experienced employees.As ofJune 30,2024,we had approximately 600 employees,of which 182,or approximately 32%,havemasters or Ph.D.degrees and we have many

144、 employees with 10 or more years of experience inrelevant fields across United States,Europe,Australia,and China.5TABLE OF CONTENTS We have also established a well-respected clinical advisory board comprised of renownedscientists:Allen S.Lichter,M.D.,chairman of our clinical advisory board and forme

145、r CEO of ASCO;Paul A.Bunn,M.D.,Distinguished Professor of Medicine and James Dudley Chair in CancerResearch,Division of Medical Oncology at the University of Colorado School of Medicine;Asher A.Chanan-Khan,M.D.,Professor of Medicine&Oncology at Mayo Clinic School ofMedicine;Arul Chinnaiyan,M.D.,Ph.D

146、.,Howard Hughes Medical Institute Investigator,American CancerSociety Research Professor,and S.P.Hicks Endowed Professor of Pathology and Urology atthe University of Michigan;Hagop M.Kantarjian,M.D.,the Samsung Distinguished Leukemia Chair in Cancer Medicine atthe University of Texas MD Anderson Can

147、cer Center;andJedd Wolchok,M.D.,Ph.D.,the Meyer Director of the Sandra and Edward Meyer Cancer Centerat Weill Cornell Medicine.Summary risk factorsInvesting in the ADSs involves significant risks.Investors in Ascentage Pharmas equity securitiesare investing in equity securities of a Cayman Islands e

148、xempted company rather than equitysecurities of our subsidiaries that have substantive business operations in China or the UnitedStates.Ascentage Pharma is a Cayman Islands exempted company that conducts operations inmultiple countries,including the Peoples Republic of China,or PRC,and the United St

149、atesthrough its subsidiaries,including Suzhou Ascentage Pharmaceutical Co.,Ltd,a limited liabilitycompany incorporated in the PRC,Guangzhou Healthquest Pharma Co.,Ltd.,a limited liabilitycompany incorporated in the PRC,Shenghe Inno Bio,a limited liability company incorporated inthe PRC,Shanghai Cent

150、agen Bio Co.,Ltd.,a limited liability company incorporated in the PRC,and Ascentage Pharma Group Inc.,a corporation incorporated in Delaware.Our operations in thePRC are primarily conducted through our PRC subsidiaries.Under this holding companystructure,investors in the ADSs are purchasing equity i

151、nterests in the Cayman Islands exemptedcompany and obtaining indirect ownership interests in the operating companies,including thePRC operating companies.This holding company structure involves unique risks to investors andinvestors may never hold direct equity interests in our operating companies,i

152、ncluding the PRCoperating companies.While we do not operate in an industry that is currently subject to foreignownership limitations in the PRC,PRC regulatory authorities could decide to limit foreignownership in our industry in the future,in which case there could be a risk that we would beunable t

153、o do business in the PRC as we are currently structured.In such event,despite ourefforts to restructure to comply with the then applicable PRC laws and regulations in order tocontinue our operations in the PRC,we may experience material changes in our business andresults of operations,our attempts m

154、ay prove to be futile due to factors beyond our control andthe value of the ADSs you invest in may significantly decline or become worthless.While ourcurrent corporate structure is not a variable interest entity,or VIE,structure and we have nointention to rely on a VIE structure in our PRC operation

155、s,if the PRC laws and regulations wereto change in the future,such changes may result in adverse changes in our operations,and theADSs may decline significantly in value.See the sections entitled“Risk factorsRisks related todoing business in the PRC,”including,but not limited,to the risk factor titl

156、ed“Risk factorsRisksrelated to doing business in the PRCThe PRC legal system is evolving,which could have amaterial adverse effect on us,”and“RegulationPRC regulation”for more information.The PRC government has significant authority to exert influence on the ability of a company withsubstantive oper

157、ations in China,such as us,to conduct its business,accept foreign investmentsor list on a U.S.or other foreign exchanges.The PRC government exerts significant oversightand discretion over the conduct of our business and may intervene with or influence ouroperations as the government deems appropriat

158、e to further regulatory,political and societalgoals.The PRC government has recently published new policies that significantly affected certainindustries,and we cannot rule out the possibility that it will in the future release regulations orpolicies regarding our industry that could result in a mate

159、rial change in our operations or thevalue of our securities,significantly limit or completely hinder our ability to offer or continue tooffer securities to investors,or cause the value of our securities to significantly decline or becomeworthless.For example,we face risks associated with 6TABLE OF C

160、ONTENTS regulatory approvals of offshore offerings,anti-monopoly regulatory actions,oversight oncybersecurity and data privacy,as well as the ability of the PCAOB to inspect our auditor.Suchrisks could result in a material change in our operations and/or the value of our ADSs or couldsignificantly l

161、imit or completely hinder our ability to offer or continue to offer ADSs and/or othersecurities to investors and cause the value of such securities to significantly decline or beworthless.The PRC government has recently published new policies and made statements,suchas those related to regulatory ap

162、provals of offshore offerings and data security or anti-monopolyconcerns,that although they did not target our company specifically,nevertheless havesignificantly affected certain industries and other PRC-based issuers as a whole,and we cannotrule out the possibility that it will in the future relea

163、se regulations or policies regarding theindustry where we operate,which could adversely affect our business,financial condition andresults of operations.Furthermore,the PRC government has recently indicated an intent to exertmore oversight and control over overseas securities offerings and other cap

164、ital markets activitiesand foreign investment in China-based companies like us.These risks could result in a materialchange in our operations and the value of our ordinary shares or the ADSs,or could significantlylimit or completely hinder our ability to conduct our business,accept foreign investmen

165、ts,ormaintain listing.You should carefully consider all of the information in this prospectus before making aninvestment in the ADSs,especially the risks and uncertainties discussed in the section of thisprospectus titled“Risk factors”immediately following this prospectus summary and informationcont

166、ained in the section of this prospectus titled“Managements discussion and analysis offinancial condition and results of operations.”The following is a summary of the principal risksand uncertainties we face:Risks related to our financial position and need for capitalWe have incurred significant net

167、losses in the past,and we intend to continue to investsubstantially in our business.As a result,we may not be able to achieve or sustain profitabilityin the future despite the commercialization of olverembatinib in China.Even if this offering is successful,we will need to obtain additional financing

168、 to fund ouroperations,and if we are unable to obtain such financing,we may be unable to complete thedevelopment and commercialization of our drug candidates,including olverembatinib.Raising additional capital may cause dilution to our shareholders,restrict our operations orrequire us to relinquish

169、rights to our drug candidates,including olverembatinib.Our credit facility may not be available to us at all or on the same terms as it has in the past.We have a limited operating history,which may make it difficult to evaluate our current businessand predict our future performance.Risks related to

170、clinical developmentOutside of China,we have not obtained any marketing authorization for any of our drugcandidates.We depend substantially on the success of olverembatinib and our other drugcandidates,several of which are in early clinical development.Clinical development of drugcandidates is inher

171、ently uncertain.Aside from the NMPA approvals we have obtained to date for olverembatinib,if clinical trials ofour drug candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA,NMPAor other comparable regulatory authorities or do not otherwise produce positive results,we may

172、incur additional costs or experience delays completing,or ultimately be unable to complete,thecommercialization of olverembatinib in the United States or other jurisdictions or thedevelopment and commercialization of our other drug candidates.Clinical drug development involves a lengthy and expensiv

173、e process with uncertain outcomes,and top-line and interim results and results of earlier studies and trials may not be predictive offuture trial results.Many of our drug candidates are being tested or used by patients who are critically ill,who maybe unfit for certain medical interventions or for w

174、hom there are no other treatments or options,which can result in heightened risk of adverse events,including death.7TABLE OF CONTENTS Interim,initial,top-line and preliminary data that we announce from time to time may materiallychange as more patient data become available and are subject to audit a

175、nd verificationprocedures.We may also selectively report data to explore certain trends that are interesting,but you may not agree with our assessment as to what might be material or appropriate.We may not be successful in our efforts to identify or discover additional drug candidates.Dueto our limi

176、ted resources and access to capital,we must,and have in the past decided to,prioritize development of certain drug candidates;these decisions may prove to be wrong andmay adversely affect our business.If we encounter difficulties enrolling patients in our clinical trials,our clinical developmentacti

177、vities could be delayed or otherwise adversely affected.Risks related to obtaining regulatory approvalThe regulatory approval processes of the FDA,NMPA and other comparable regulatoryauthorities are lengthy,time consuming and inherently unpredictable,and if we are ultimatelyunable to obtain regulato

178、ry approval for our drug candidates,our business will be substantiallyharmed.The FDA,NMPA and other comparable foreign regulatory authorities may not accept data fromtrials conducted in locations outside of their jurisdiction.If we are unable to obtain NMPA approval for our drug candidates to be eli

179、gible for an expeditedregistration pathway as Category 1 drug candidates,the time and cost we incur to obtainregulatory approvals may increase.Even if we receive such Category 1 designation,it may notlead to a faster development,review or approval process.Where appropriate,we plan to secure approval

180、 from the FDA or comparable foreign regulatoryauthorities through the use of accelerated registration pathways.If we are unable to obtain suchapproval,we may be required to conduct additional preclinical studies or clinical trials beyondthose that we contemplate,which could increase the expense of o

181、btaining,and delay thereceipt of,necessary marketing approvals.Even if we receive accelerated approval from theFDA,if our confirmatory trials do not verify clinical benefit,or if we do not comply with rigorouspost-marketing requirements,the FDA may seek to withdraw accelerated approval.Risks related

182、 to commercializationWe are substantially dependent on the commercial success of olverembatinib.If we are unableto maintain or increase sales of olverembatinib,our ability to generate revenue and our financialcondition will be adversely affected.If we are not able to obtain,or experience delays in o

183、btaining,required regulatory approvals forour drug candidates(including olverembatinib outside of China),we will not be able tocommercialize our drug candidates in the markets that we desire,and our ability to generaterevenue will be materially impaired.We have and may continue to license commercial

184、ization or other rights and pursue other formsof collaboration worldwide,which can expose us to additional risks of conducting business inadditional international markets.We have limited commercialization experience,and we may lack the necessary expertise,personnel and resources to successfully comm

185、ercialize any of our other products that receiveregulatory approval on our own or together with collaborators.Risks related to our intellectual propertyIf we are unable to protect and defend our proprietary technology,or obtain and maintain patentprotection for our drug candidates,our competitors co

186、uld develop and commercializetechnology and drugs similar or identical to ours,and our ability to successfully commercializeour technology and drugs may be adversely affected.Risks related to our reliance on third partiesWe rely on third parties to manufacture a portion of our drug candidate supplie

187、s,and we intendto rely on third parties for at least a portion of the manufacturing process of our drugcandidates,including olverembatinib.8TABLE OF CONTENTS Our business could be harmed if those third parties fail to provide us with sufficient quantities ofproduct or fail to do so at acceptable qua

188、lity levels or prices.We have entered into collaborations and other relationships with leading biotechnologycompanies and research institutions and may form or seek other collaborations or strategicalliances or enter into additional licensing arrangements in the future,and we may not realizethe bene

189、fits of such alliances or licensing arrangements.We rely on third parties to conduct our preclinical studies and clinical trials and we must workeffectively with collaborators to develop our drug candidates.In many cases,our drugcandidates,including olverembatinib,are studied in third-party studies,

190、including in investigator-initiated trials.If these third parties do not successfully carry out their contractual duties or meetexpected deadlines,or fail to design,execute and complete appropriate and timely studies ofour drug candidates we may not be able to obtain regulatory approval for or comme

191、rcialize ourdrug candidates and our business could be substantially harmed.Risks related to our industry,business and operationsIf our manufacturing facilities are damaged or destroyed or production at such facilities isotherwise interrupted,our business and prospects would be negatively affected.We

192、 have significantly increased our research,development,manufacturing,and commercialcapabilities,and we may experience difficulties in managing our growth.Any failure to comply with applicable regulations and industry standards or obtain or maintainvarious licenses and permits could harm our reputati

193、on and our business,results of operationsand prospects.Risks related to doing business in the PRCWe are subject to the filing requirements in connection with this offering and listing,and may besubject to further approval,filing or other requirements with PRC governmental authorities inconnection wi

194、th future capital-raising activities.Recent greater oversight by the Cyberspace Administration of China,or CAC,over datasecurity,particularly for companies seeking to list on a foreign exchange,could significantly limitor completely hinder our ability in capital raising activities and materially and

195、 adversely affectour business and the value of your investment.If the PCAOB is unable to inspect or investigate completely our auditors located in Chinabecause of a position taken by a foreign authority and the SEC identifies the company as aCommission-Identified Issuer under the Holding Foreign Com

196、panies Accountable Act for twoconsecutive years,the ADSs will be delisted and our ordinary shares and ADSs will beprohibited from trading on a national securities exchange or in the over-the-counter marketunder the Holding Foreign Companies Accountable Act.The delisting of the ADSs,or the threatof t

197、heir being delisted,and a prohibition from trading,may materially and adversely affect thevalue of your investment.We may be restricted from transferring our scientific data abroad.Risks related to our ordinary shares,the ADSs and this offeringThe dual listing of our ordinary shares and the ADSs may

198、 adversely affect the liquidity andvalue of the ADSs and ordinary shares.The trading prices of the ADSs are likely to be volatile,which could result in substantial lossesto you.We have identified a material weakness in our internal control over financial reporting and mayidentify additional material

199、 weaknesses in the future.If we fail to implement and maintain aneffective system of internal controls to remediate our material weakness over financialreporting,we may be unable to accurately report our results of operations,meet our reportingobligations or prevent fraud,and investor confidence and

200、 the market price of the ADSs may bematerially and adversely affected.9TABLE OF CONTENTS Corporate structureThe following diagram illustrates our corporate structure,including our principal subsidiaries,categorized into onshore entities,which are organized and registered in the PRC,and offshoreentit

201、ies,which are organized and registered outside of the PRC,as of the date of this prospectus:Cash flows through our organizationCash is transferred among Ascentage Pharma and our subsidiaries in the following manner:(1)funds are transferred to Ascentage Pharmas subsidiaries from Ascentage Pharma Grou

202、pInternational as needed as capital contributions or shareholder loans,as the case may be;and(2)dividends or other distributions may be paid by our subsidiaries to Ascentage Pharma.Oursubsidiaries generate and retain cash from operating activities and re-invest in their respectivebusiness.None of ou

203、r subsidiaries have made distributions to shareholders.In the future,Ascentage Pharmas ability to pay dividends,if any,to its shareholders and to service any debt itmay incur partially depends upon dividends paid by our subsidiaries.Apart from cash transferredin connection with paid-in capital and s

204、hareholder loans,no cash or other assets have beentransferred between Ascentage Pharma Group International and a subsidiary,no subsidiaries(including PRC subsidiaries)paid dividends or made other distributions to Ascentage PharmaGroup International,and no dividends or distributions were paid or made

205、 to U.S.investors.In thefuture,cash proceeds raised from financing activities may be transferred by Ascentage Pharmathrough our subsidiaries via capital contributions and shareholder loans,as the case may be,andour subsidiaries may pay dividends to their respective shareholders.Payment of dividends

206、issubject to restrictions under the PRC law.Any limitation on the ability of our PRC subsidiaries tomake payments to us could have a material and 10TABLE OF CONTENTS adverse effect on our ability to conduct our business.For a detailed discussion of applicable PRCregulations governing distribution of

207、 dividends,see“RegulationPRC regulationsPRCregulations relating to dividend distribution.”In addition,the PRC government imposesregulations on the convertibility of Renminbi into foreign currencies and the remittance of fundsout of China.Governmental regulations of currency conversion may limit our

208、ability to paydividends and other obligations and affect the value of your investment.We currently intend toretain most,if not all,of our available funds and any future earnings to operate and expand ourbusiness.See“Dividend policy.”Regulatory permissions and licenses for our operations in the PRC a

209、nd thisofferingWe conduct our business in mainland China primarily through our PRC subsidiaries.Ouroperations in mainland China are governed by laws and regulations of mainland China.On February 17,2023,the CSRC promulgated the Trial Administrative Measures of OverseasSecurities Offering and Listing

210、 by Domestic Companies,or the Trial Measures,and relevant notesand supporting guidelines,which became effective on March 31,2023.Pursuant to the TrialMeasures,PRC domestic companies that seek to offer and list securities in overseas markets,either in direct or indirect means,are required to fulfill

211、the filing procedure with the CSRC andreport relevant information.The Trial Measures provide that if the issuer meets both of thefollowing criteria,the overseas securities offering and listing conducted by such issuer will bedeemed an indirect overseas offering by a PRC domestic company:(1)50%or mor

212、e of any of theissuers operating revenue,total profit,total assets or net assets as documented in its auditedconsolidated financial statements for the most recent fiscal year is accounted for by PRCdomestic companies;and(2)the main parts of the issuers business activities are conducted inmainland Ch

213、ina,its main place(s)of business are located in mainland China or the majority ofsenior management staff in charge of its business operations and management are PRC citizensor have their usual place(s)of residence located in mainland China.On the same day,the CSRC also held a press conference for th

214、e release of the Trial Measuresand issued the Notice on Administration for the Filing of Overseas Offering and Listing byDomestic Companies,or the Filing Notice,which,among others,clarifies that(1)a six-monthtransition period will be granted to domestic companies which,prior to the effective date of

215、 theTrial Measures,have already obtained the approval from overseas regulatory authorities or stockexchanges,such as completion of registration in the market of the United States,but have notcompleted the overseas listing;and(2)domestic companies that have already submitted validapplications for ove

216、rseas offering and listing but have not obtained approval from overseasregulatory authorities or stock exchanges on or prior to the effective date of the Trial Measures,may reasonably arrange the timing for submitting their filing applications with the CSRC,andshall complete the filing before comple

217、tion of their overseas offering and listing.Taking into consideration the above-mentioned criteria,this offering is an indirect offering underthe Trial Measures,and we are therefore subject to the filing requirements of the CSRC.We arerequired to fulfill the filing procedure with the CSRC in accorda

218、nce with the Trial Measures andthe completion of the filing procedure is a condition to this offering and listing.We confidentiallysubmitted the filing with the CSRC in connection with this offering in accordance with the TrialMeasures,and in December 2024,we received the filing notice from the CSRC

219、 in relation to ouroverseas offering and listing,which indicates that we have completed the required filingapplication procedures for this offering.We have been closely monitoring regulatory developments in China regarding any necessaryapprovals from the CSRC,the CAC,or other PRC regulatory authorit

220、ies required for overseaslistings and securities offerings.However,we cannot predict the impact of these regulations onthe listing status of the ADSs and/or other securities,or on any of our future security offerings inforeign countries.For more detailed information,see“Risk factorsRisks related to

221、doingbusiness in the PRCWe are subject to the filing requirements in connection with this offeringand listing,and may be subject to further approval,filing or other requirements with PRCgovernmental authorities in connection with future capital-raising activities.”If(1)we do not receive or maintain

222、any required permissions or approvals,(2)we inadvertentlyconcluded that certain permissions or approvals have been acquired or are not required,or(3)applicable laws,regulations or 11TABLE OF CONTENTS interpretations thereof change and we become subject to the requirement of additionalpermissions or

223、approvals in the future,we may not be able to obtain such permissions orapprovals in a timely manner,or at all,and such approvals may be rescinded even if obtained.Any such circumstance could subject us to sanctions imposed by the PRC regulatory authorities,which could include fines and penalties,pr

224、oceedings against us,and other forms of sanctions,and our business,financial condition and results of operations may be materially and adverselyaffected.For more information,see“Risk factorsRisks related to doing business in the PRC.”Recent regulatory developmentOn July 6,2021,the relevant PRC gover

225、nment authorities issued the Opinions on StrictlyScrutinizing on Illegal Securities Activities in Accordance with the Law.These opinions call forstrengthened regulation over illegal securities activities,supervision of overseas securitiesofferings and listings by China-based companies,and propose to

226、 take effective measures,suchas promoting the development of relevant regulatory systems,to deal with perceived risks orincidents faced by China-based overseas-listed companies.On February 17,2023,the ChinaSecurities Regulatory Commission,or the CSRC,released the Trial Administrative Measures ofOver

227、seas Securities Offering and Listing by Domestic Companies,or the Trial Measures,and fivesupporting guidelines,which took effect on March 31,2023.Pursuant to the Trial Measures,domestic companies that seek to list overseas,both directly and indirectly,should fulfill the filingprocedure and report re

228、levant information to the CSRC.If a domestic company fails to completethe filing procedure or conceals any material fact or falsifies any major content in its filingdocuments,such domestic company may be subject to administrative penalties,such as order torectify,warnings,fines,and its controlling s

229、hareholders,actual controllers,the person directly incharge and other directly liable persons may also be subject to administrative penalties,such aswarnings and fines.As advised by our PRC legal advisor,this offering will be identified as anindirect overseas issuance and listing under the Trial Mea

230、sures.We are therefore subject to theapproval,filing or other requirements of the CSRC in connection with this offering.Accordingly,we shall fulfill the filing procedure with the CSRC as per requirement of the Trial Measures.The revised Measures of Cybersecurity Review as promulgated by a total of t

231、hirteengovernmental departments of the PRC,including the Cyberspace Administration of China,or theCAC,came into effect on February 15,2022.The revised Measures of Cybersecurity Reviewstipulated that,in addition to network products and services acquired by critical informationinfrastructure operators

232、,online platform operators are also subject to cybersecurity review if theycarry out data processing activities that affect or may affect national security.Moreover,onlineplatform operators listing in a foreign country with more than one million users personalinformation data must apply for a cybers

233、ecurity review with the Cybersecurity Review Office.Therevised Measures of Cybersecurity Review further elaborated the factors to be considered whenassessing the national security risks of the relevant activities.Since our business operation is notan operator of a network platform with personal info

234、rmation of over one million users,we shouldnot be required to undergo the cybersecurity review for this offering and the listing of the ADSsunder the revised Measures of Cybersecurity Review.On February 24,2023,the CSRC,jointly with other relevant governmental authorities,promulgated the Provisions

235、on Strengthening Confidentiality and Archives Management ofOverseas Securities Issuance and Listing by Domestic Enterprises,or the Confidentiality andArchives Management Provisions,which took effect on March 31,2023.The Confidentiality andArchives Management Provisions outline obligations of issuers

236、 listed in overseas markets withoperations in mainland China when they provide information involving state secrets or sensitiveinformation to their securities service providers(such as auditors)and overseas regulators.Inaddition,under the Confidentiality and Archives Management Provisions,such issue

237、rs will also berequired to obtain approval from the CSRC and other authorities in mainland China beforeaccepting any investigation or inspection by overseas regulators.There are uncertainties withrespect to the interpretation and implementation of Confidentiality and Archives ManagementProvisions.Re

238、cent developmentsIn the following tables,we provide certain selected unaudited historical interim condensedconsolidated financial data.The selected unaudited interim condensed consolidated statement ofprofit or loss data for the nine months 12TABLE OF CONTENTS ended September 30,2024 and 2023 and un

239、audited interim condensed consolidated statement offinancial position data as of September 30,2024 have been prepared on the same basis as ouraudited consolidated financial statements,and,in the opinion of management,reflect alladjustments,consisting only of normal recurring adjustments,that are nec

240、essary for the fairstatement of such data.The selected unaudited consolidated financial data were prepared by ourmanagement based only upon information available to them as of the date of this prospectus andare not necessarily indicative of our operating results for any future period and should not

241、beviewed as a substitute for our full interim or annual financial statements prepared in accordancewith International Financial Reporting Standards,or IFRS Accounting Standards,issued by theInternational Accounting Standard Board,or the IASB.For the purposes of this section only,translations from RM

242、B to U.S.dollars and from U.S.dollars to RMB are made at RMB7.0176 toUS$1.00,the exchange rate set forth for cable transfers in the City of New York,as certified bythe Federal Reserve Bank of New York on September 30,2024.Please refer to“Managementsdiscussion and analysis of financial condition and

243、results of operations”and“Risk factors”included elsewhere in this prospectus for information regarding trends and other factors that mayaffect our results of operations.Selected unaudited interim condensed consolidated statement of profit orloss data Nine months ended September 30,2024 2024 2023(in

244、thousands)RMB US$RMB Revenue 876,769 124,939 175,500 Cost of sales (22,101 (3,149 (24,517 Gross profit 854,668 121,790 150,983 Other income and gains 34,830 4,963 47,720 Selling and distribution expenses (145,504 (20,734 (153,611 Administrative expenses (141,255 (20,129 (138,308 Research and develop

245、ment expenses (707,098 (100,761 (515,936 Other expenses (7,277 (1,037 (3,820 Finance costs (50,778 (7,236 (74,801 Share of(loss)/profit of a joint venture (1,450 (207 199 Loss before tax (163,864 (23,351 (687,574 Income tax credit 3,856 550 3,995 Loss for the period (160,008 (22,801 (683,579 Revenue

246、For the nine months ended September 30,2024,we generated revenue of RMB876.8 million(US$124.9 million)from intellectual property income,sales of pharmaceutical products andcommercialization rights income,compared to RMB175.5 million for the nine months endedSeptember 30,2023,representing an increase

247、 of RMB701.3 million,or 400.0%,which wasprimarily attributable to intellectual property income of RMB678.4 million from Takeda and theincrease in sales of pharmaceuticals products of RMB11.9 million.Operating expensesFor the nine months ended September 30,2024,(i)selling and distribution expenses de

248、creasedby RMB8.1 million,or 5.3%,to RMB145.5 million(US$20.7 million),compared toRMB153.6 million for the nine months ended September 30,2023,primarily attributable to thedecrease in selling and distribution expenses incurred in the commercialization of olverembatiniband other products,(ii)research

249、and development expenses increased by RMB191.2 million,or37.1%,to RMB707.1 million(US$100.8 million),from RMB515.9 million for the nine monthsended September 30,2023,primarily attributable to increased internal research and development 13)TABLE OF CONTENTS expenses for olverembatinib and lisaftoclax

250、,(iii)administrative expenses increased byRMB3.0 million,or 2.1%,to RMB141.3 million(US$20.1 million),from RMB138.3 million for thenine months ended September 30,2023,primarily attributable to the increase in legal andconsulting service fees,and(iv)finance costs decreased by RMB24.0 million,or 32.1%

251、,toRMB50.8 million(US$7.2 million),from RMB74.8 million for the nine months endedSeptember 30,2023,primarily attributable to decreased interest incurred in relation to bankborrowings.Loss for the periodOur loss for the nine months ended September 30,2024 was RMB160.0 million(US$22.8 million),compare

252、d to RMB683.6 million for the nine months ended September 30,2023.Selected unaudited consolidated statement of financial position As of September 30,2024 2024(in thousands)RMB US$Total non-current assets 1,160,261 165,336 Total current assets 1,637,170 233,295 Total current liabilities 1,158,485 165

253、,085 Total non-current liabilities 1,185,472 168,927 Total equity 453,474 64,619 As of September 30,2024,we had cash and bank balances of RMB1,479.3 million(US$210.8 million).Implications of the Holding Foreign Companies Accountable ActPursuant to the HFCAA and related regulations,as amended by the

254、Consolidated AppropriationsAct,2023,if the SEC determines that we have filed an audit report issued by a registered publicaccounting firm that the PCAOB has determined that it is unable to inspect and investigatecompletely because of a position taken by a foreign authority,the SEC will identify us a

255、s a“Commission-Identified Issuer.”If we are identified as a Commission-Identified Issuer for twoconsecutive years,the trading of our securities on any U.S.national securities exchange,as wellas any over-the-counter trading in the United States,will be prohibited.Our auditor,Ernst&Young Hua Ming LLP,

256、is an independent registered accounting firm based in mainland China.InAugust 2022,the PCAOB,the CSRC and the Ministry of Finance of the PRC signed theStatement of Protocol,which establishes a specific and accountable framework for the PCAOB toconduct inspections and investigations of PCAOB-governed

257、 accounting firms in mainland Chinaand Hong Kong.On December 15,2022,the PCAOB announced that it was able to securecomplete access to inspect and investigate completely PCAOB-registered public accounting firmsheadquartered in mainland China and Hong Kong in 2022.The PCAOB Board vacated itsprevious 2

258、021 determinations that the PCAOB was unable to inspect or investigate completelyregistered public accounting firms headquartered in mainland China and Hong Kong.However,whether the PCAOB will continue to be able to satisfactorily conduct inspections of PCAOB-registered public accounting firms headq

259、uartered in mainland China and Hong Kong is subject touncertainties and depends on a number of factors out of our and our auditors control.ThePCAOB continues to demand complete access in mainland China and Hong Kong movingforward and pursue ongoing investigations and initiate new investigations as n

260、eeded.ThePCAOB has also indicated that it will act immediately to consider the need to issue newdeterminations that it is unable to inspect or investigate completely registered public accountingfirms in a jurisdiction because of positions taken by a foreign authority,if needed.If the PCAOB isunable

261、to inspect and investigate completely registered public accounting firms located in Chinaand Hong Kong and we fail to retain another registered public accounting firm that the PCAOB isable to inspect and investigate completely for two consecutive years in 2024 and beyond,theADSs will be delisted fro

262、m Nasdaq,and our ordinary shares and ADSs will be prohibited fromtrading over the counter in the United States.The risks and uncertainties related to the HFCAAand related regulations,including the possibility of delisting and a prohibition from trading,couldcause the value of the ADSs and ordinary s

263、hares to significantly decline or become 14TABLE OF CONTENTS worthless.For details,see“Risk factorsRisks related to doing business in the PRCIf thePCAOB is unable to inspect or investigate completely auditors located in China for twoconsecutive years,the ADSs will be delisted and our ordinary shares

264、 and ADSs will be prohibitedfrom trading in the over-the-counter market under the Holding Foreign Companies AccountableAct.The delisting of the ADSs,or the threat of their being delisted,may materially and adverselyaffect the value of your investment.”Channels for disclosure of informationInvestors,

265、the media,and others should note that,following the effectiveness of the registrationstatement of which this prospectus forms a part,we intend to announce material information tothe public through filings with the HKEx,the SEC,the investor relations page on our website,press releases,public conferen

266、ce calls,and webcasts.The information disclosed by the foregoing channels could be deemed to be material information.As such,we encourage investors,the media,and others to follow the channels listed above andto review the information disclosed through such channels.However,information disclosedthrou

267、gh these channels does not constitute part of this prospectus and is not incorporated byreference herein.We intend to post any updates to the list of disclosure channels through which we will announceinformation on the investor relations page on our website.Our corporate informationOur headquarters

268、and principal executive office is located at 68 Xinqing Road,Suzhou IndustrialPark,Suzhou,Jiangsu,China.Our telephone number at this address is+86-512-85557777.Ourregistered office in the Cayman Islands is located at the offices of Walkers Corporate Limited,190Elgin Avenue,George Town,Grand Cayman K

269、Y19008,Cayman Islands.Investors should submitany inquiries to the address and telephone number of our principal executive office as set forthabove.Our corporate website is ,and the information contained on,or that can beaccessed through,our website is not a part of,and is not incorporated by referen

270、ce into,thisprospectus.Our agent for service of process in the United States is Ascentage Pharma GroupInc.,located at 700 King Farm Blvd,Suite 510,Rockville,Maryland 20850.“Ascentage Pharma,”the Ascentage Pharma logo,and other trademarks or service marks ofAscentage Pharma Group International appear

271、ing in this prospectus are the property ofAscentage Pharma Group International.This prospectus contains additional trade names,trademarks,and service marks of others,which are the property of their respective owners.Solely for convenience,trademarks and trade names referred to in this prospectus may

272、 appearwithout the or TM symbols.Certain risks associated with our corporate structureWe are an exempted company incorporated under the laws of the Cayman Islands that conductsmost of our operations in China through our PRC subsidiaries.In addition,some our executiveofficers reside within China for

273、a significant portion of the time.As a result,it may be difficult forour shareholders to effect service of process upon us or those persons inside China.The recognition and enforcement of foreign judgments are provided for under the PRC CivilProcedures Law.PRC courts may recognize and enforce foreig

274、n judgments in accordance withthe requirements of the PRC Civil Procedures Law based either on treaties or similararrangements between China and the jurisdiction where the judgment is made or on principles ofreciprocity between jurisdictions.China does not have treaties or similar arrangements and o

275、nlyhas limited reciprocity arrangements with the United States,the Cayman Islands or many othercountries and regions that provide for the reciprocal recognition and enforcement of foreignjudgments as of the date of this prospectus.Therefore,recognition and enforcement in China ofjudgments of a court

276、 in any of these non-PRC jurisdictions in relation to any matter not subject toa binding arbitration provision may be difficult 15TABLE OF CONTENTS or impossible.In addition,according to the PRC Civil Procedures Law,PRC courts will notenforce a foreign judgment if it is decided as having violated th

277、e basic principles of PRC laws ornational sovereignty,security or public interest.As a result,it is uncertain whether and on whatbasis a PRC court would enforce a judgment rendered by a court in the United States or theCayman Islands.The SEC,U.S.Department of Justice and other U.S.authorities often

278、have substantial difficultiesin bringing and enforcing actions against non-U.S.companies and non-U.S.persons,includingcompany directors and officers,in certain emerging markets,including China.Legal and otherobstacles to obtaining information needed for investigations or litigation or to obtaining a

279、ccess tofunds outside the United States,lack of support from local authorities,and other various factorsmake it difficult for the U.S.authorities to pursue actions against non-U.S.companies andindividuals,who may have engaged in fraud or other wrongdoing.Additionally,publicshareholders investing in

280、the ADSs have limited rights and few practical remedies in emergingmarkets where we operate,as shareholder claims that are common in the United States,including class actions under securities law and fraud claims,generally are difficult or impossibleto pursue as a matter of law or practicality in ma

281、ny emerging markets,including China.See also“Risk factorsRisks related to doing business in the PRCYou may experience difficulties ineffecting service of legal process,enforcing foreign judgments or bringing actions in the regionswhere we operate against us or our management named in this prospectus

282、 based on foreignlaws.”Holding company structureAs of the date of this prospectus,Ascentage Pharma Group International has not previouslydeclared or paid any cash dividend or dividend in kind,and has no plan to declare or pay anydividends in the near future on its ordinary shares or the ADSs.Ascenta

283、ge Pharma GroupInternational is a holding company with no operations of its own.Ascentage Pharma GroupInternational conducts its business operations through its subsidiaries,including its subsidiariesin China.If the PRC government deems that any of our business operations carried out by ourHong Kong

284、 or PRC subsidiaries were to be restricted or prohibited from foreign investment in thefuture,we may be required to stop our business operations in China,and we could be subject tomaterial penalties or be forced to relinquish our interests in the affected operations.Such eventscould result in a mate

285、rial change in our operations and a material change in the value of oursecurities,including causing the value of such securities to significantly decline or becomeworthless.If we become profitable,Ascentage Pharma Group Internationals ability to paydividends,if any,to the shareholders and ADS invest

286、ors and to service any debt it may incur willcome from dividends paid by its operating subsidiaries.Under PRC laws and regulations,our PRC subsidiaries are subject to certain restrictions withrespect to paying dividends or otherwise transferring any of their net assets offshore toAscentage Pharma Gr

287、oup International.In particular,under the current effective PRC laws andregulations,dividends may be paid only out of distributable profits upon satisfaction of relevantstatutory conditions and procedures.Distributable profits are the net profit after tax as determinedunder PRC GAAP,less any recover

288、y of accumulated losses and appropriations to statutory andother reserves required to be made.Each of our PRC subsidiaries is required to appropriate 10%of the net profits as reported in its respective statutory financial statements(after offsetting anyprior years losses)to the statutory reserves un

289、til such reserves have reached 50%of itsrespective registered capital.In addition,the PRC Enterprise Income Tax Law,or EIT Law,and itsimplementation rules provide that a withholding tax rate of up to 10%will be applicable todividends payable by PRC companies to non-PRC-resident enterprises unless ot

290、herwiseexempted or reduced according to treaties or arrangements between the PRC central governmentand governments of other countries or regions where the non-PRC-resident enterprises areincorporated.Furthermore,the payment of current account items,including profit distributions,trade andservice rel

291、ated foreign exchange transactions,can be made in foreign currencies without priorapproval from State Administration of Foreign Exchange,or SAFE,or its local branches,providedthat(i)the declaration and payment of such current account items comply with applicable PRClaws and regulations and the const

292、itutional documents of the related company,and(ii)theremittance of dividends and other distributions out of the PRC complies with the proceduresrequired by the relevant PRC laws and regulations relating to foreign exchange administrationand withholding tax provisions,such as the overseas investment

293、registrations by ourshareholders or the ultimate 16TABLE OF CONTENTS shareholders of our corporate shareholders who are PRC residents.However,where RMB is tobe converted into foreign currency and remitted out of the PRC to pay capital expenses,such asthe repayment of loans denominated in foreign cur

294、rencies,approval from or registration withcompetent government authorities or its authorized banks is required.The PRC government maytake measures from time to time to restrict access to foreign currencies for current account orcapital account transactions in accordance with the procedural requireme

295、nts of PRC laws.If theforeign exchange control system prevents us from obtaining sufficient foreign currencies to satisfyour foreign currency demands,we may not be able to pay dividends in foreign currencies to ouroffshore intermediary holding companies or ultimate parent company,and therefore,oursh

296、areholders or investors in the ADSs.Further,we cannot assure you that new regulations orpolicies will not be promulgated in the future,which may further restrict the remittance of RMBinto or out of the PRC.We cannot assure you,in light of the restrictions in place,or anyamendment to be made from tim

297、e to time,that our current or future PRC subsidiaries will be ableto satisfy their respective payment obligations that are denominated in foreign currencies,including the remittance of dividends outside of the PRC.Implications of being an emerging growth companyWe qualify as an“emerging growth compa

298、ny”pursuant to the Jumpstart Our Business StartupsAct of 2012,as amended,or the JOBS Act.An emerging growth company may take advantage ofspecified reduced reporting and other requirements compared to those that are otherwiseapplicable generally to public companies.These provisions include exemption

299、from the auditorattestation requirement under Section 404 of the Sarbanes-Oxley Act of 2002 in the assessmentof the emerging growth companys internal control over financial reporting.The JOBS Act alsoprovides that an emerging growth company does not need to comply with any new or revisedfinancial ac

300、counting standards until such date that a private company is otherwise required tocomply with such new or revised accounting standards.We do not plan to opt out of suchexemptions afforded to an emerging growth company.As a result,our operating results andfinancial statements may not be comparable to

301、 the operating results and financial statements ofother companies who have adopted the new or revised accounting standards.We will remain an emerging growth company until the earliest of(1)the last day of the fiscal yearduring which we have total annual gross revenues of at least US$1.235 billion;(2

302、)the last day ofour fiscal year following the fifth anniversary of the completion of this offering;(3)the date onwhich we have,during the preceding three-year period,issued more than US$1.0 billion in non-convertible debt;or(4)the date on which we are deemed to be a“large accelerated filer”underthe

303、Securities Exchange Act of 1934,as amended,or the Exchange Act,which would occur if wehave been a public company for at least 12 months and the market value of the ADSs andordinary shares that are held by non-affiliates exceeds US$700 million as of the last business dayof our most recently completed

304、 second fiscal quarter.Once we cease to be an emerging growthcompany,we will not be entitled to the exemptions provided in the JOBS Act discussed above.Implications of being a foreign private issuerWe are also a foreign private issuer within the meaning of the rules under the Exchange Act,andas such

305、 we are exempt from certain provisions of the securities rules and regulations in theUnited States that are applicable to U.S.domestic issuers.Moreover,the information we arerequired to file with or furnish to the SEC will be less extensive and less timely compared to thatrequired to be filed with t

306、he SEC by U.S.domestic issuers.In addition,as an exempted companyincorporated in the Cayman Islands,we are permitted to adopt certain home country practices inrelation to corporate governance matters that differ significantly from the corporate governancestandards of Nasdaq.See the sections of this

307、prospectus titled“Risk factorsRisks related to ourordinary shares,the ADSs and this offeringWe are a foreign private issuer within the meaningof the rules under the Exchange Act,and as such we are exempt from certain provisionsapplicable to U.S.domestic public companies”and“Risk factorsRisks related

308、 to our ordinaryshares,the ADSs and this offeringAs an exempted company incorporated in the CaymanIslands,we are permitted to adopt certain home country practices in relation to corporategovernance matters that differ significantly from the Nasdaq corporate governance standards;these practices may a

309、fford less protection to shareholders than they would enjoy if we complyfully with the Nasdaq corporate governance standards.”17TABLE OF CONTENTS Conventions that apply to this prospectusExcept where the context otherwise requires and for purposes of this prospectus only:“ADSs”refer to American depo

310、sitary shares,each of which representsof our ordinaryshares;“ADRs”refer to the American depositary receipts that evidence the ADSs;“Ascentage Pharma,”“we,”“us,”“our company,”and“our”refer to Ascentage Pharma GroupInternational,a Cayman Islands exempted company,and its subsidiaries;“CCASS”refers to t

311、he Central Clearing and Settlement System established and operated byHKSCC;“China”or“PRC”refer to the Peoples Republic of China,and only in the context of describingthe PRC laws,rules,regulations,regulatory authorities,and any PRC entities or citizens undersuch rules,laws and regulations and other l

312、egal or tax matters in this prospectus,excludes,Taiwan,the Hong Kong Special Administrative Region and the Macau Special AdministrativeRegion;“ordinary shares”refer to our ordinary shares,par value US$0.0001 per share;“RMB”and“Renminbi”refer to the legal currency of China;“HKEx”refers to The Stock E

313、xchange of Hong Kong Limited;“HK$”refers to the legal currency of Hong Kong;“HKSCC”refers to Hong Kong Securities Clearing Company Limited;“Hong Kong Listing Rules”refer to the Rules Governing the Listing of Securities on HKEx,asamended,supplemented,or otherwise modified from time to time;“Innovent”

314、refers to Innovent Biologics(Suzhou)Co.,Ltd.,a company with limited liabilityestablished under the laws of the PRC;“SFC”refers to the Securities and Futures Commission of Hong Kong;and“US$,”“U.S.dollars”or“dollars”refer to the legal currency of the United States.18TABLE OF CONTENTS The offeringADSs

315、offered by usADSs(orADSs if the underwritersexercise their option to purchase additional ADSsin full).Offering price per ADSOn,the closing price of our ordinary shareson the HKEx was HK$per ordinary shares,equivalent to a price of US$per ADS,basedon the exchange rate set forth on the cover page ofth

316、is prospectus.For a discussion of factorsconsidered in determining the price to the public ofthe ADSs,see“Underwriting.”ADSs outstanding immediately afterthis offeringADSs(orADSs if the underwritersexercise their option to purchase additional ADSsin full).Ordinary shares outstandingimmediately after

317、 this offeringordinary shares(orordinary shares ifthe underwriters exercise their option to purchaseadditional ADSs in full).The ADSsEach ADS representsof our ordinaryshares.The depositary(as identified below)will be theholder of the underlying ordinary sharesrepresented by the ADSs and you will hav

318、e therights of an ADR holder as provided in the depositagreement among us,the depositary andregistered holders and beneficial owners of ADSsfrom time to time.You may surrender your ADSs to the depositary towithdraw the ordinary shares underlying yourADSs.The depositary will charge you a fee for anys

319、uch exchange.We may amend or terminate the deposit agreementfor any reason without your consent.Anyamendment that imposes or increases fees orcharges or which materially prejudices anysubstantial existing right you have as an ADSholder will not become effective as to outstandingADSs untildays after

320、notice of theamendment is given to ADS holders.If anamendment becomes effective,you will be boundby the deposit agreement as amended if youcontinue to hold your ADSs.To better understand the terms of the ADSs,seethe section of this prospectus titled“Description ofAmerican depositary shares.”We also

321、encourageyou to read the deposit agreement,which is anexhibit to the registration statement that includesthis prospectus.Underwriters option to purchaseadditional sharesWe have granted the underwriters an option for aperiod of 30 days to purchase uptoadditional ADSs.Use of proceedsWe intend to use t

322、he net proceeds from thisoffering,together with our existing cash and cashequivalents,as follows:(1)to fund the researchand development of 19TABLE OF CONTENTS olverembatinib,including activities related to thevarious registrational trials and other clinical trials,as well as pursuing approvals with

323、regulatoryauthorities in multiple countries;(2)to fund theresearch and development of lisaftoclax,includingactivities related to the various registrational trialsand other clinical trials,as well as pursuingapprovals with regulatory authorities in multiplecountries;and(3)to fund the research anddeve

324、lopment of our other product candidates,andstrengthen our technology platforms and researchand development capabilities.We intend to useany remaining net proceeds for working capital andgeneral corporate purposes.See the section titled“Use of proceeds”for moreinformation.Lock-upWe,our directors,exec

325、utive officers,and certain ofour significant shareholders have agreed with theunderwriters,subject to certain exceptions,not tosell,transfer or otherwise dispose of any ADSs,ordinary shares or similar securities for a period of180 days after the date of this prospectus.See thesections of this prospe

326、ctus titled“Shares eligiblefor future sale”and“Underwriting”for moreinformation.Risk factorsSee the section of this prospectus titled“Riskfactors”beginning on page 24 and otherinformation included in this prospectus for adiscussion of the risks related to investing in theADSs.You should carefully co

327、nsider these risksbefore deciding to invest in the ADSs.ListingWe have applied to list the ADSs on the NasdaqGlobal Market under the symbol“AAPG.”Ourordinary shares are currently listed on the HKExunder the stock code“6855.”Payment and settlementThe underwriters expect to deliver the ADSsagainst pay

328、ment on,2025,through thefacilities of the Depository Trust Company,or DTC.DepositaryJPMorgan Chase Bank,N.A.The total number of ordinary shares that will be issued and outstanding immediately after thisoffering is based on 314,654,405 ordinary shares issued and outstanding as of June 30,2024,and exc

329、ludes:3,178,159 of our ordinary shares issuable upon the exercise of outstanding options to purchaseour ordinary shares outstanding as of June 30,2024 under our Pre-IPO Share Option Scheme,at a weighted average exercise price of HK$0.01(US$0.0014)per share,of which options topurchase 7,938,470 ordin

330、ary shares were vested at a weighted average exercise price ofHK$0.01(US$0.0014)per share;42,586 of our ordinary shares subject to RSUs outstanding as of June 30,2024 under our 2021RSU Scheme;1,390,709 of our ordinary shares subject to RSUs outstanding as of June 30,2024 under our2022 RSU Scheme;20,

331、707,462 of our ordinary shares reserved for future issuance under our Post-IPO ShareOption Scheme;2,087,693 of our ordinary shares reserved for future issuance under our 2018 RSU Scheme;20TABLE OF CONTENTS 1,266,217 of our ordinary shares reserved for future issuance under our 2021 RSU Scheme;and2,9

332、31,626 of our ordinary shares reserved for future issuance under our 2022 RSU Scheme.Except as otherwise indicated,all information in this prospectus assumes:no exercise of outstanding share options or settlement of outstanding RSUs subsequent toJune 30,2024;andno exercise by the underwriters of the

333、ir option to purchase additional ADSs in this offering.Summary consolidated financial dataThe following summary consolidated statement of profit or loss data for the fiscal years endedDecember 31,2023 and 2022 and summary consolidated statement of financial position data asof December 31,2023 and 2022 have been derived from our audited consolidated financialstatements included elsewhere in this pr