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1、The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of thisApplication Proof,make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever forany loss howsoever arising from or in relian
2、ce upon the whole or any part of the contents of this Application Proof.Application Proof of君聖泰醫藥HighTide Therapeutics,Inc.(the“Company”)(Incorporated in the Cayman Islands with limited liability)WARNINGThe publication of this Application Proof is required by The Stock Exchange of Hong Kong Limited(
3、the“Exchange”)/theSecurities and Futures Commission(the“Commission”)solely for the purpose of providing information to the public in HongKong.This Application Proof is in draft form.The information contained in it is incomplete and is subject to change which can bematerial.By viewing this document,y
4、ou acknowledge,accept and agree with the Company,its sponsors,overall coordinators,advisers or members of the underwriting syndicate that:(a)this document is only for the purpose of providing information about the Company to the public in Hong Kong and not forany other purposes.No investment decisio
5、n should be based on the information contained in this document;(b)the publication of this document or supplemental,revised or replacement pages on the Exchanges website does not giverise to any obligation of the Company,its sponsors,overall coordinators,advisers or members of the underwriting syndi
6、cateto proceed with an offering in Hong Kong or any other jurisdiction.There is no assurance that the Company will proceedwith the offering;(c)the contents of this document or supplemental,revised or replacement pages may or may not be replicated in full or in partin the actual final listing documen
7、t;(d)the Application Proof is not the final listing document and may be updated or revised by the Company from time to time inaccordance with the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited;(e)this document does not constitute a prospectus,offering circular,n
8、otice,circular,brochure or advertisement offering to sellany securities to the public in any jurisdiction,nor is it an invitation to the public to make offers to subscribe for or purchaseany securities,nor is it calculated to invite offers by the public to subscribe for or purchase any securities;(f
9、)this document must not be regarded as an inducement to subscribe for or purchase any securities,and no such inducementis intended;(g)neither the Company nor any of its affiliates,advisers or underwriters is offering,or is soliciting offers to buy,anysecurities in any jurisdiction through the public
10、ation of this document;(h)no application for the securities mentioned in this document should be made by any person nor would such application beaccepted;(i)the Company has not and will not register the securities referred to in this document under the United States Securities Actof 1933,as amended,
11、or any state securities laws of the United States;(j)as there may be legal restrictions on the distribution of this document or dissemination of any information contained in thisdocument,you agree to inform yourself about and observe any such restrictions applicable to you;and(k)the application to w
12、hich this document relates has not been approved for listing and the Exchange and the Commission mayaccept,return or reject the application for the subject public offering and/or listing.No offer or invitation will be made to the public in Hong Kong until after a prospectus of the Company has been r
13、egistered with theRegistrar of Companies in Hong Kong in accordance with the Companies(Winding Up and Miscellaneous Provisions)Ordinance(Chapter 32 of the Laws of Hong Kong).If an offer or an invitation is made to the public in Hong Kong in due course,prospectiveinvestors are reminded to make their
14、investment decisions solely based on a prospectus of the Company registered with theRegistrar of Companies in Hong Kong,copies of which will be distributed to the public during the offer period.IMPORTANT:If you are in any doubt about any of the contents of this document,you should seek independent p
15、rofessional advice.君聖泰醫藥HighTide Therapeutics,Inc.(Incorporated in the Cayman Islands with limited liability)REDACTEDNumber of REDACTED underthe REDACTED:REDACTED Shares(subject to theREDACTED)Number of REDACTED:REDACTED Shares(subject toadjustment)Number of REDACTED:REDACTED Shares(subject to adjus
16、tmentand the REDACTED)Maximum REDACTED:HK$REDACTED per REDACTED,plusbrokerage of 1.0%,SFC transaction levyof 0.0027%,Stock Exchange trading fee of0.00565%and AFRC transaction levy of0.00015%(payable in full onREDACTED in Hong Kong Dollars andsubject to refund)Nominal Value:US$0.0001 per ShareREDACTE
17、D:REDACTEDJoint Sponsors,REDACTED,REDACTED,REDACTED and REDACTEDREDACTED,REDACTED,REDACTED and REDACTEDHong Kong Exchanges and Clearing Limited,The Stock Exchange of Hong Kong Limited and Hong Kong Securities Clearing Company Limited take no responsibility for thecontents of this document,make no re
18、presentation as to its accuracy or completeness,and expressly disclaim any liability whatsoever for any loss howsoever arising from or inreliance upon the whole or any part of the contents of this document.A copy of this document,having attached thereto the documents specified in“Appendix VDocuments
19、 Delivered to the Registrar of Companies and on Display”to this document,has been registered by the Registrar of Companies in Hong Kong as required by Section 342C of the Companies(Winding Up and Miscellaneous Provisions)Ordinance(Chapter32 of the Laws of Hong Kong).The Securities and Futures Commis
20、sion and the Registrar of Companies in Hong Kong take no responsibility for the contents of this document orany other document referred to above.Our Company is incorporated in the Cayman Islands and a significant portion of our businesses are located in the PRC.Potential REDACTED should be aware of
21、the differencesin legal,economic and financial systems between the Cayman Islands,the PRC and Hong Kong and that there are different risk factors relating to the REDACTED in ourCompany.Potential REDACTED should also be aware that the regulatory frameworks in the Cayman Islands and the PRC are differ
22、ent from the regulatory framework in HongKong and should take into consideration the different market nature of our REDACTED.Such differences and risk factors are set out in the sections headed“Risk Factors”and“Regulatory Overview”.The REDACTED is expected to be fixed by agreement between the REDACT
23、ED and the REDACTED(for themselves and on behalf of the REDACTED)and us on theREDACTED.The REDACTED is expected to be on or around REDACTED and,in any event,not later than REDACTED.The REDACTED will be not more thanHK$REDACTED per REDACTED and is currently expected to be not less than HK$REDACTED pe
24、r REDACTED.If,for any reason,the REDACTED is not agreed byREDACTED between the REDACTED and the REDACTED(for themselves and on behalf of the REDACTED)and us,the REDACTED will not proceed and will lapse.Applicants for REDACTED are required to pay,on application,the maximum REDACTED of HK$REDACTED for
25、 each REDACTED together with brokerage fee of 1%,SFC transaction levy of 0.0027%,Stock Exchange trading fee of 0.00565%and AFRC transaction levy of 0.00015%,subject to refund if the REDACTED as finally determinedis less than HK$REDACTED.The REDACTED(for themselves and on behalf of the REDACTED),and
26、with our consent,may,where considered appropriate,reduce the number of REDACTEDand/or the indicative REDACTED range below that is stated in this document(which is HK$REDACTED to HK$REDACTED)at any time prior to the morning of thelast day for lodging applications under the REDACTED.In such case,notic
27、es of the reduction in the number of REDACTED and/or the indicative REDACTED rangewill be published on the website of our Company at and on the website of the Stock Exchange at www.hkexnews.hk as soon as practicable followingthe decision to make such reduction,and in any event not later than the mor
28、ning of the day which is the last day for lodging applications under the REDACTED.Furtherdetails are set forth in“Structure of the REDACTED and“How to Apply for REDACTED”in this document.The obligations of the Hong Kong REDACTED under the REDACTED to subscribe for,and to procure applicants for the s
29、ubscription for,the REDACTED,aresubject to termination by the REDACTED(for themselves and on behalf of the Hong Kong REDACTED)if certain grounds arise prior to 8:00 a.m.on the day thatREDACTED in the REDACTED commences on the Hong Kong Stock Exchange.Such grounds are set out in the section headed“RE
30、DACTEDREDACTEDArrangements and ExpensesREDACTEDGrounds for termination”in this document.The REDACTED have not been and will not be registered under the Securities Act or any state securities law in the United States and may not be REDACTED,REDACTED,pledged or transferred within the United States or
31、to,or for the account or benefit of United States persons,except in transactions exempt from,or not subject to,the registrationrequirements of the Securities Act.The REDACTED are being REDACTED and REDACTED(i)in the United States solely to QIBs as defined in Rule 144A pursuant to anexemption from re
32、gistration under the Securities Act and(ii)outside the United States in offshore transactions in reliance on Regulation S under the Securities Act.REDACTEDTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNI
33、NG”ON THE COVER OF THIS DOCUMENT.IMPORTANTREDACTEDREDACTEDTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.IMPORTANTREDACTEDTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND S
34、UBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.IMPORTANTREDACTEDTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON T
35、HE COVER OF THIS DOCUMENT.EXPECTED TIMETABLE(1)i REDACTEDTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.EXPECTED TIMETABLE(1)ii REDACTEDTHIS DOCUMENT IS IN DRAFT FORM,IN
36、COMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.EXPECTED TIMETABLE(1)iii REDACTEDTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH T
37、HE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.EXPECTED TIMETABLE(1)iv IMPORTANT NOTICE TO REDACTEDThis document is issued by us solely in connection with the REDACTED and doesnot constitute an REDACTED to sell or a solicitation of an REDACTED to buy anysecurity other than the REDACTED by t
38、his document pursuant to the REDACTED.Thisdocument may not be used for the purpose of,and does not constitute,an REDACTED ora solicitation of an REDACTED to subscribe for or buy,any security in any otherjurisdiction or in any other circumstances.No action has been taken to permit aREDACTED of the RE
39、DACTED or the distribution of this document in any jurisdictionother than Hong Kong.The distribution of this document and the REDACTED and sale ofthe REDACTED in other jurisdictions are subject to restrictions and may not be madeexcept as permitted under the applicable securities laws of such jurisd
40、ictions pursuant toregistration with or authorization by the relevant securities regulatory authorities or anexemption therefrom.You should rely only on the information contained in this document and theREDACTED to make your REDACTED decision.We have not authorized anyone toprovide you with informat
41、ion that is different from what is contained in this document.Anyinformation or representation not made in this document must not be relied on by you ashaving been authorized by us,the Joint Sponsors,the REDACTED,the REDACTED,the REDACTED,the REDACTED,the REDACTED,any of the REDACTED,any ofour or th
42、eir respective directors,officers or representatives,or any other person or partyinvolved in the REDACTED.PageEXPECTED TIMETABLE.iCONTENTS.vSUMMARY.1DEFINITIONS.26GLOSSARY OF TECHNICAL TERMS.39FORWARD-LOOKING STATEMENTS.49RISK FACTORS.51WAIVERS AND EXEMPTIONS.109INFORMATION ABOUT THIS DOCUMENT AND T
43、HE REDACTED.114THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.CONTENTS v PageDIRECTORS AND PARTIES INVOLVED IN THE REDACTED.118CORPORATE INFORMATION.123INDUSTRY OVERVIEW
44、.126REGULATORY OVERVIEW.160HISTORY,REORGANIZATION AND CORPORATE STRUCTURE.199BUSINESS.238DIRECTORS AND SENIOR MANAGEMENT.356SHARE CAPITAL.376SUBSTANTIAL SHAREHOLDERS.379CONNECTED TRANSACTION.382FINANCIAL INFORMATION.391FUTURE PLANS AND USE OF REDACTED.425REDACTED.430STRUCTURE OF THE REDACTED.441HOW
45、TO APPLY FOR REDACTED.452APPENDIX IACCOUNTANTSREPORT.I-1APPENDIX IIREDACTED.II-1APPENDIX IIISUMMARY OF THE CONSTITUTION OF THE COMPANYAND CAYMAN ISLANDS COMPANY LAW.III-1APPENDIX IVSTATUTORY AND GENERAL INFORMATION.IV-1APPENDIX VDOCUMENTS DELIVERED TO THE REGISTRAR OFCOMPANIES AND ON DISPLAY.V-1THIS
46、 DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.CONTENTS vi This summary aims to give you an overview of the information contained in thisdocument.As this is a summary,it doe
47、s not contain all the information that may beimportant to you.You should read this document in its entirety before you decided toREDACTED in the REDACTED.There are risks associated with any REDACTED.Some of the particular risks in REDACTED in the REDACTED are set out in“RiskFactors”of this document.
48、You should read that section carefully before you decide toREDACTED in the REDACTED.In particular,we are a biotechnology company seekingto REDACTED on the Main Board of the Stock Exchange under Chapter 18A of theListing Rules on the basis that we are unable to meet the requirements under Rule 8.05(1
49、),(2)or(3)of the Listing Rules.There are unique challenges,risks and uncertaintiesassociated with REDACTED in companies such as ours.Your REDACTED decisionshould be made in light of these considerations.OVERVIEWEstablished in 2011,we are a biopharmaceutical company specializing in the discovery,deve
50、lopment and commercialization of multifunctional,multi-targeted therapies for the treatmentof metabolic and digestive diseases.We have developed a product pipeline of one Core Product andotherfourproductcandidatesin-house.OurCoreProduct,HTD1801(berberineursodeoxycholate),a new molecular entity,is a
51、gut-liver anti-inflammatory metabolic modulatorwhich targets multiple pathways pivotal to metabolic regulation,including those associated withmetabolic and digestive diseases.WE MAY NOT BE ABLE TO SUCCESSFULLY DEVELOP AND/OR MARKET OURCORE PRODUCT.Our PipelineAs of the Latest Practicable Date,we hav
52、e researched and developed in-house a pipelinewith five proprietary drug candidates covering nine indications,including five indications that areat clinical stage.The following chart summarizes the development status of our drug candidates asof the Latest Practicable Date.THIS DOCUMENT IS IN DRAFT F
53、ORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 1 CandidateMechanism/TargetIndicationRightDesignationsPre-ClinicalPhase IPhase IIPhase IIICompetent or regulatory authoritiesHTD1801Berberine
54、ursodeoxycholate(BUDC)MASHGlobal(1)FTDT2DMGlobalSHTGGlobalPSCGlobal(1)FTD,ODDPBCGlobalHTD4010Polypeptide drugAHGlobalHTD1804UndisclosedObesityGlobalHTD1805UndisclosedMetabolic diseaseGlobalHTD2802UndisclosedIBDGlobal1 1Ph IIa completed in US;Ph IIb initiated in US and Hong Kongto be initiated in Mex
55、ico and Mainland ChinaPh II completed in Mainland China,Ph III initiated in Mainland China(2)Ph II to be initiated in US(3)Ph II completed in US and Canada;IND approval obtained in China(4)Ph II completed in USPh I completed in AustraliaCore ProductMetabolic diseaseDigestive diseaseUpcoming Mileston
56、eFDA,NMPA,The Federal Commission for Protection against Sanitary Risks,Department of HealthPh IIb Mexico and Mainland China clinical sites to be initiated in December 2023 and studies in all clinical sites expected to be completed in 2025NMPAPh III to be completed in 2025FDAPh II to be initiated in
57、1H 2024FDA,Health Canada,NMPAFDATGAPh II to be initiated in late 2024 or beyondIND-enablingIND-enablingIND-enablingJoint collaboration strategyJoint collaboration strategyN/AN/AN/AAbbreviations:MASH:metabolic dysfunction-associated steatohepatitis,formerly known as nonalcoholic steatohepatitis or NA
58、SH;T2DM:type 2 diabetes mellitus;SHTG:severe hypertriglyceridemia;PSC:primary sclerosing cholangitis;PBC:primary biliary cholangitis;AH:alcoholic hepatitis;IBD:inflammatory bowel disease;FTD:Fast Track Designation;ODD:Orphan Drug Designation;Ph:Phase.Notes:1.Researched and developed in-house.We have
59、 granted Hepalink an exclusive,sublicensable(solely to Hepalinks designated wholly-owned subsidiaries),non-transferable license for the commercializationof HTD1801 for MASH and PSC in Europe.The Company reserved the rights to(i)research,develop and manufacturing HTD1801 globally;(ii)commercialize HT
60、D1801 for any indications outside Europe;(iii)commercialize HTD1801 in Europe for any indications other than MASH and PSC;and(iv)import and export HTD1801.For details,see“Business Collaboration Agreement HTD1801 License-OutAgreement”and“Connected Transaction”.2.In November 2023,we initiated the two
61、Phase III clinical trials(i.e.one with HTD1801 as a standalone treatment and one with HTD1801 as an add-on therapy with metformin)for the T2DM indication ofour self-developed HTD1801 in China.We expect to complete those two Phase III studies in 2025.For details,see“Business Clinical Stage Candidate
62、Core Product HTD1801 Summary of ClinicalTrials of HTD1801”.3.We have completed a Phase Ib/IIa trial for hypercholesterolemia in Australia and a Phase IIa trial for MASH in the United States.Based on FDAs written responses to the pre-IND meeting,the FDA concludedthat the available preclinical and cli
63、nical data of the above trials was adequate to support the initiation of Phase II trial for SHTG.4.We have obtained the IND approval from the NMPA to conduct the China part in the Phase II MRCT of PSC.However,due to COVID-19 pandemic,we did not initiate the China part of the Phase II clinicaltrial.A
64、fter the completion of Phase II trials in the United States and Canada,the China part of the Phase II trial is not required because the Phase II trials had met the endpoints in the United States and Canada.5.Competent authority in respective jurisdictions:US FDA;Mainland China NMPA;Canada Health Can
65、ada;Australia TGA;Hong Kong The Department of Health;Mexico The FederalCommission for Protection against Sanitary Risks.THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SU
66、MMARY 2 Core ProductHTD1801 is a salt with an ionic bond formed between two active moieties(the molecule orion responsible for the physiological or pharmacological action of the drug substance),berberine(“BBR”)and ursodeoxycholic acid(“UDCA”).The two active moieties BBR and UDCA have along history o
67、f medicinal applications as treatments for gut and liver diseases in traditionalChinese medicine.In HTD1801,BBR and UDCA work in tandem in the salt form with uniquemicrostructure to produce distinct and improved properties as demonstrated in our studies.Theimproved properties are not observed with e
68、ither of the individual active moieties or their physicalmixture.Our clinical results show that HTD1801 delivers a therapeutic effect for patientsincluding metabolic improvement,liver protection,anti-inflammation and antioxidative stress.However,therapeutic effect of the Core Product is based on pre
69、liminary clinical data only which isyet to be validated in later clinical trials,and the Core Product may fail to meet the primary andsecondary endpoints at the late-stage clinical trials due to higher clinical development risks.Fordetails,see“Risk Factors Risks relating to development,clinical tria
70、ls and regulatory approvalof our drug candidates the Core Product may fail to meet the primary and secondary endpointsat the late-stage clinical trials due to higher clinical development risks resulted from HTD1801being a new molecular entity and potential rejection from competent authorities”in thi
71、sDocument.HTD1801 is currently being developed by us for indications across metabolicdysfunction-associated steatohepatitis(“MASH”,formerly known as nonalcoholic steatohepatitisor NASH),type 2 diabetes mellitus(“T2DM”),severe hypertriglyceridemia(“SHTG”),primarysclerosing cholangitis(“PSC”)and prima
72、ry biliary cholangitis(“PBC”)globally,with a focus oncomorbidities and a potential for indication expansion.However,we may face uncertainties inclinical trial development which are subject to a variety of factors,including satisfactory safetyand efficacy results from clinical trials,successful enrol
73、lment of patients,performance of CROsand other parties involved in clinical trial development and others.For more details,please see“Risk Factors Risks relating to development,clinical trials and regulatory approval of our drugcandidates Clinical drug development involves a lengthy and expensive pro
74、cess with uncertainoutcomes,and we may be unable to commercialize our drug candidates at all.”The following diagram illustrates mechanism of action of HTD1801:HTD1801:A Gut-Liver Anti-inflammatory Metabolic Modulator(“GLAM”)InflammationSteatosisFibrosisCholestasisCholangitisAtherogenic LipidsOxidati
75、ve StressGlucose ClearanceBeneficial MicrobiotaBody WeightInflammationInsulin ResistanceGlycemic ControlHarmful MicrobiotaHarmful MicrobiotaHTD1801Berberine UrsodeoxycholateSource:Company DataTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJ
76、UNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 3 In the United States,we have received fast track designation(“FTD”)from the Food andDrug Administration(“FDA”)for MASH and PSC indications,as well as orphan drug designation(“ODD”)for the PSC indication.Under the Orphan
77、Drug Act,the FDA granted the ODD toHTD1801 for PSC on the condition that HTD1801 is intended to treat a rare disease of PSCaffecting fewer than 200,000 individuals in the United States.For more details,please see“Regulatory Overview Laws and Regulations in the United States and EU Orphan Drugs.”Acco
78、rding to CIC,HTD1801 is the first PSC drug candidate to receive FTD from the FDA.TheFTD is based on available preclinical and clinical data that demonstrate the potential to address anunmet medical need and is intended to facilitate an expedited regulatory review process.In China,we received governm
79、ent support from“Major National Science and Technology Projects for NewDrug Development”under the“National 13th Five-Year Plan”,which may further accelerate thedomestic market approval for HTD1801.According to the current development progress andtimeline,we expect to submit the first New Drug Applic
80、ation(“NDA”)for HTD1801 for T2DM in2025 in China.As of the Latest Practicable Date,we held 58 patents and patent applications in relation toour Core Product,representing four types of patents that have been applied in differentjurisdictions,including a new molecular entity(a“composition-of-matter”pa
81、tent),the processused to manufacture the drug,the way the drug is used and new formulations of the drug to protectour assets.The reasons for applying these patents in various jurisdictions are to provide extensivepatent protections and maintain our Core Products exclusivity in these jurisdictions.We
82、 havesuccessfully obtained composition of matter patent for HTD1801 in many countries and regions,including the United States,China,the European Union and Japan,as well as crystalline formpatent in United States and China.Considering the market size and addressable patient population of MASH and T2D
83、M,wehave and will continue to prioritize our resources for the clinical development of the MASH andT2DM indications of HTD1801.We are currently conducting the Phase IIb clinical trial for theMASH indication of our self-developed HTD1801,and may seek joint development opportunitiesfor its Phase III c
84、linical trials.For T2DM,we completed two Phase I clinical trials,one Phase Ibclinical trial,and one Phase II clinical trial in China,which are all required by the NMPA.InNovember 2023,we initiated the two Phase III clinical trials(i.e.one with HTD1801 as astandalone treatment and one with HTD1801 as
85、 an add-on therapy with metformin)for the T2DMindication of our self-developed HTD1801 in China.We expect to complete those two Phase IIIstudies in 2025.In addition,we have no immediate plans to conduct clinical trials for andcommercialise T2DM outside of China.Since the completion of Phase II clini
86、cal trials for PSC inAugust 2020 and for PBC in May 2022,no clinical development progress has been made for thePSC and PBC indications of HTD1801.We have no immediate development plans and will notallocate any net REDACTED of the REDACTED to these two indications,and we are seekingcollaboration oppo
87、rtunities with global partners for future clinical development andcommercialisation of HTD1801 for PSC and PBC indications.Despite the rebound in liverbiochemistry during the follow-up period in the Phase II trial for PBC and a long period of clinicaldevelopment suspension for the PBC and PSC indica
88、tions,we have not encountered anydifficulties in identifying collaboration opportunities with global partners for future clinicaldevelopment and commercialisation of HTD1801 for PBC and PSC.In addition to Hepalinkobtaining a license to commercialize HTD1801 in Europe for the MASH and PSC indications
89、,weare in negotiations with global partners for the future development of HTD1801 for such orphandiseases of cholestasis(the category of diseases which PSC and PBC fall within);however,due toTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJU
90、NCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 4 the time required to negotiate the commercial terms,as of the Latest Practicable Date,nocollaboration agreements had been entered into.The follow-up periods in the Phase II clinical trialfor PBC,during which HTD1801 treat
91、ment was withdrawn,showed a worsening in liverbiochemistry compared with baseline,also suggesting the efficacy of HTD1801.Therefore,webelieve that it has no impact on our clinical development.We designed the MRCTs for HTD1801 for MASH and PSC indications.The use of MRCTfor MASH and PSC was determine
92、d in 2017.The Phase IIb clinical trial for MASH and Phase IIclinical trial for PSC were conducted in the form of MRCT,and MRCT would also be the approachfor the clinical trials going forward for MASH and PSC.We believe MRCTs can expedite globalclinical development and facilitate registration in mult
93、iple regions across the globe.We use thesame study protocol for IND approval of clinical trials and conducting clinical trials in differentphases after obtaining IND approvals in each of MRCTs jurisdictions.The clinical results of theMRCT in various jurisdictions can be used to support registration
94、approval by the competentauthorities in those jurisdictions.There are no differences in primary endpoints,extent or type ofclinical trials to be conducted across various jurisdictions but might be slight differences inmaterials to be submitted among the different regulatory bodies.For Phase IIb MRCT
95、 of HTD1801 for MASH indication in the United States,Hong Kong,Mexico and Mainland China,the details of communications with competent authorities have beenset forth in the section“Business Clinical-Stage Candidates Core Product HTD1801 Material Communications with Competent Authorities”.In April 202
96、3,we submitted the Phase IIbstudy protocol to the FDA and we did not receive any comments or rejections from the FDA withinthe 30-day clearance period.We also obtained the IND approvals in Hong Kong and MainlandChina in August and September 2023,respectively,and filed an IND application in Mexico in
97、 July2023.For Phase II MRCT of HTD1801 for PSC in the United States,Mainland China and Canada,the details of communications with competent authorities have been set forth in the section“Business Clinical-Stage Candidates Core Product HTD1801 Material Communicationswith Competent Authorities”.We obta
98、ined IND approvals from the FDA in 2017,and from theNMPA and the Health Canada in 2019.Other Product CandidatesBuilding on our expertise in the development of HTD1801,we have also invested in anddeveloped our pipeline to cover alcoholic hepatitis(“AH”),obesity,inflammatory bowel disease(“IBD”)and ot
99、her metabolic diseases to address large unmet medical needs.For AH,we areadvancing the early clinical development of HTD4010.AH is one of the manifestations fromalcohol-associated liver disease(“ALD”)characterized by acute liver inflammation.There arecurrently no approved drug treatments specificall
100、y targeting AH.The current standard of care,corticosteroids,often used in patients with severe AH,has not shown a meaningful long-termsurvival benefit and usually carries serious side effects.HTD4010 is a Toll-like receptor 4(“TLR4”)inhibitor potentially capable of modulating the innate immune respo
101、nse and theresulting liver inflammation,a major contributor to AH pathogenesis.In animal studies,HTD4010demonstrated potent beneficial effects for AH,alleviating signs of severe liver injury and reducingsystemic inflammation.Our completed Phase I clinical trial demonstrated its favorable safetyprofi
102、le in healthy humans.THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 5 We are also evaluating HTD1804 for the treatment of obesity,which is a growing globalhealth
103、 risk associated with a wide range of comorbidities,most notably cardiovascular diseases(“CVDs”)and T2DM.Preclinical studies show that HTD1804 may be an important modulator ofenergy metabolism as well as cardiovascular protection.HTD1805,another drug candidate in ourpipeline,is a multifunctional sma
104、ll molecule drug for the treatment of metabolic diseases.HTD2802 is a preclinical-stage,multifunctional drug for the treatment of IBD.In preclinicalstudies,HTD2802 has shown positive effects on stool formation and the occurrence of fecal occultblood,as well as reducing inflammatory cytokine levels a
105、nd preventing pathological injury.Business ModelSelf-DevelopmentWe adopt a self-development business model.All our product candidates are self-developed.In addition,we have granted Shenzhen Hepalink Pharmaceutical Group Co.,Ltd.(深圳市海普瑞藥業集團股份有限公司)(“Hepalink”)an exclusive,sublicensable(solely to Hepal
106、inkswholly-owned subsidiaries),non-transferable license of HTD1801 for all aspects ofcommercialization for the indications of MASH and PSC in Europe.We retain the rights to(i)research and develop HTD1801 worldwide;(ii)manufacture HTD1801 worldwide;(iii)commercialize HTD1801 for any indications outsi
107、de Europe;(iv)commercialize HTD1801 in anyregion in Europe for indications other than for MASH and PSC;and(v)import and exportHTD1801 for the purposes described above.Please see the paragraphs headed“HTD1801License-Out Agreement”in this section for more details.Our CapabilitiesOur R&D team has profo
108、und expertise,deep understanding,and broad developmentexperience in metabolic and digestive diseases.Our R&D team pioneered the identification ofcompounds designed to modulate multiple pathways underlying chronic diseases,providing aunique advantage in addressing the unmet clinical needs across comp
109、lex pathologies.Our CMCteam is specialized in preclinical and clinical support throughout the drug development process.The CMC function plays a critical role in drug development.It is responsible for developing safe,robust,and economically sound production processes for our drug substances and drug
110、products,and ensuring their quality meets regulatory requirements.We have not established our in-housesales team.We will pursue the commercialization strategy of external cooperation for future assetsto maximize the value of our drug candidates globally.ADDRESSABLE MARKETS AND COMPETITIVE LANDSCAPE
111、OF CORE PRODUCTThere has been an increasing industry focus on metabolic and digestive diseases in recentyears,which has driven our continued investment in the development of new and more effectivetreatments.According to CIC,there are significant commercial opportunities across multiplemetabolic and
112、digestive diseases including MASH,T2DM,SHTG,PSC and PBC,togetherrepresenting a large global market size of US$330 billion in 2022.THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS D
113、OCUMENT.SUMMARY 6 MASH is a growing health issue,particularly in developed countries,due to the rising ratesof obesity and metabolic syndrome.As of the end of 2022,the prevalence of MASH reached 40.4million,20.7 million and 35.0 million in China,the United States and Europe,respectively,according to
114、 CIC.There are currently no approved therapies for the treatment of MASH.Whilelifestyle modifications and management of underlying conditions can help slow or stop theprogression of MASH,there are currently no approved pharmacologic therapies thatcomprehensively improve the full spectrum of MASH,fro
115、m inflammation and liver cell damage tofibrosis and cirrhosis.Therefore,there is a significant need for safe and effective pharmacologictherapies to treat MASH,specifically therapies that comprehensively improve the pathologicspectrum of MASH.Effects on cardiometabolic parameters such as lipid metab
116、olism,glycemiccontrol,and body weight are also important considerations given the prevalence of suchcomorbidities in patients with MASH.Lastly,given the pathogenetic complexity andheterogeneity of the disease,there is growing interest in developing therapies that target multiplepathways involved in
117、the development and progression of MASH.We may face uncertainties in clinical trial development which are subject to a variety offactors,including satisfactory safety and efficacy results from clinical trials,successful enrollmentof patients,and performance of CROs and other parties involved in clin
118、ical trial development andothers.For example,Intercepts ocaliva,one of the most advanced MASH drugs in the pipeline,filed the second application for MASH but it was rejected by the FDA in June 2023.The FDAreviewers flagged increased risk of diabetes and liver injury from using the oral tablets,calle
119、dobeticholic acid(“OCA”),for the treatment of MASH.The FDA concluded that benefits of ocalivadid not outweigh the risks in MASH patients with fibrosis based on current data.Interceptexpressed that continuing a long-term outcomes study as requested by the FDA may not beeconomically feasible and has d
120、ecided to discontinue all MASH-related investment,which has anegative impact on MASH market.Therefore,favorable safety profiles matter in new drugdevelopment for chronic diseases.We believe that such risk is low in our HTD1801 developmentgiven its good preliminary clinical results.We may fail to dev
121、elop the HTD1801 MASH indication,which is one of the majorindications of HTD1801,in particular the high probability of failure to achieve the primary andsecond efficacy endpoints in late-stage clinical trials because HTD1801 is based on a newmolecular entity,which is yet to be tested in large-scale
122、clinical studies,thus facing higher clinicalrisks.Despite that HTD1801 is different from ocaliva in many aspects,such as mechanism ofactions,PK profiles and others as applicable,our development of HTD1801 may still be subject todevelopment risks,including those faced by ocaliva in their development.
123、T2DM is one of the most common metabolic disorders worldwide,which is characterized bychronic hyperglycemia resulting from insulin deficiency due to pancreatic-cell dysfunction andinsulin resistance.According to CIC,China has the largest number of T2DM patients globally,with approximately 123.2 mill
124、ion patients in 2022,this number is expected to increase to 141.8million by 2032.Despite low diagnosis rate at 50%in 2022 and relatively low penetration rate,themarket size in T2DM treatment reached US$7.9 billion in 2022 in China.T2DM and metabolicdysfunction-associated steatotic liver disease(“MAS
125、LD”,formerly known as nonalcoholic fattyliver disease or NAFLD)are closely interrelated metabolic diseases.A key function of the liver isthe storage and management of energy(e.g.,sugars and lipids)in the body,as such a dysregulationin energy management or sensitivity(e.g.,insulin resistance in T2DM)
126、may have a substantialimpact in that function.T2DM aggravates MASLD and results in a higher risk of diseaseTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 7 progr
127、ession and outcomes including MASH,cirrhosis and hepatocellular carcinoma.Similarly,MASLD compounds the severity of T2DM and with an increase in comorbidities such ascardiovascular disease and liver-related outcomes.The worldwide prevalence of MASLD amongpeople with T2DM is 55.5%;in China the preval
128、ence of T2DM with MASLD was 64.1 million asof the end of 2022.According to CIC,there are currently no approved drugs which can providesufficient and comprehensive therapeutic benefits for both T2DM and MASLD.And most drugsunder development are designed for targeting a single target.The goal in treat
129、ing these patients isto halt or reverse the progression of T2DM and MASLD,thereby reducing the risk of clinicaloutcomes associated with advanced disease.Therefore,an ideal therapy for patients with T2DMand MASLD should provide comprehensive benefits across a wide variety of parameters whichencapsula
130、te the spectrum of these diseases.SHTG is the presence of high levels of triglycerides.The diagnosis of hypertriglyceridemia(“HTG”)is defined by the presence of serum triglycerides(“TGs”)greater than 150 mg/dL withSHTG being defined by TGs greater than or equal to 500 mg/dL.As of the end of 2022,the
131、prevalence of SHTG reached 1,586.4 thousand,339.8 thousand and 813.0 thousand in China,theUnited States and Europe,respectively,according to CIC.Dietary modification is one of thecurrent standard of cares(“SoC”)in treating patients with SHTG.In addition to dietarymodification,fibrates,prescription o
132、mega-3 fatty acids or statins are also considered as SoC ofSHTG to reduce risk of pancreatitis.Unfortunately,while each of these classes of therapeuticsoffer benefit in the treatment of SHTG,each of them still leaves a large fraction of patients with anincomplete response to treatment or presents ad
133、ditional risks or adverse reactions.Furthermore,while the existing therapies for SHTG offer a benefit in treating high TGs,they offer limitedbenefit in the treatment of the constellation of metabolic issues in orbit around or underlying theTG levels(e.g.,T2DM,MASLD/MASH,obesity).PSC is a rare,chroni
134、c cholestatic liver disease characterized by intrahepatic or extrahepaticbile duct injury,or both.Inflammation and fibrosis of the bile ducts leads to stricturing,impairedbile flow(i.e.cholestasis),and progressive liver dysfunction.As of the end of 2022,the prevalenceof PSC reached 171.9 thousand,48
135、.4 thousand and 60.7 thousand in China,the United States andEurope,respectively,according to CIC.PSC has a high incidence of liver related morbidity andmortality,cholangiocarcinoma,and an increased risk for colorectal cancer.There is also a strongassociation of PSC and inflammatory bowel disease.Pri
136、or to the liver transplant era,death fromliver failure was the leading outcome in PSC;but now,death due to cholangiocarcinoma(“CCA”)has been reported to be more common.The exact pathogenesis of PSC is not fully understood,butit is believed to be a complex interplay of genetic,environmental,and immun
137、e factors.Despite theseriousness of the disease,there is no available therapy for patients with PSC,and standard of careconsists of supportive therapies to manage symptoms and prevent complications.Given thepathogenesis of PSC is complex and multifactorial,an effective treatment should target multip
138、leunderlying mechanisms that contribute to the development and progression of PSC.PBC is a chronic,slowly progressive autoimmune,cholestatic liver disease characterized byfemale predominance.PBC is characterized by progressive inflammation and destruction of smallbile ducts,resulting in fibrosis,cir
139、rhosis,and eventually leading to complications of end-stageliver disease and death.As of the end of 2022,the prevalence of PBC reached 789.8 thousand,135.4 thousand and 175.6 thousand in China,the United States and Europe,respectively,accordingto CIC.There are only two approved treatments for PBC to
140、 date,each with their own limitations.While UDCA is prescribed for patients with PBC as the current first-line therapy,up to 40%ofTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS D
141、OCUMENT.SUMMARY 8 PBC patients do not achieve an adequate response to UDCA as a monotherapy.In the United Statesand Europe,obeticholic acid(“OCA”)is approved as second-line therapy for the treatment ofpatients with PBC patients who have had an inadequate response to or are intolerant of UDCA.Approxi
142、mately 40%of patients with PBC who are incomplete responders to UDCA alone also donot achieve a complete response with the addition of OCA.Further,OCA is contraindicated forpatients with PBC who have compensated cirrhosis with evidence of portal hypertension orpatients with decompensated cirrhosis.T
143、olerability concerns related to the use of OCA include anexacerbation of pruritus,a common symptom of PBC.Hence,there remains a significant unmetmedical need for patients with PBC.We face fierce competition from approved products and product candidates under clinicaldevelopment in the MASH,T2DM,SHTG
144、,PSC and PBC markets.We may also face potentialcompetition from off-label treatment paradigms for MASH and PSC.The indications of suchapproved products may also be expanded and potentially compete with HTD1801.As there aremultiple product candidates currently in Phase III clinical trials for each of
145、 the targeted indicationsof HTD1801,our development and commercialization of HTD1801 may be adversely affected ifsome or all of such product candidates receive NDA approval prior to HTD1801.For example,theFDA may request head-to-head studies for HTD1801 before granting the approval,which mayimpose h
146、igher risk of clinical failure and also delay the original development plan.For details,see“Risk Factors Risks relating to development,clinical trial and regulatory approvals of our drugcandidates We may face intense competition and rapid technological change and the possibilitythat our competitors
147、may develop therapies that are similar,more advanced,or more effective thanours,which may adversely affect our financial condition and our ability to successfullycommercialize our drug candidates”in this Document.STRENGTHSWe believe the following strengths differentiate us from our competitors:Devel
148、op novel multifunctional,multi-target therapies for metabolic and digestivediseases to treat patients as a wholeHTD1801,a“pipeline-in-a-product”new molecular entity with the potential tobecome a therapy for MASH,T2DM,and other metabolic and digestive diseasesPipeline of new molecular entities with a
149、 therapeutic profile to address unmet needsin metabolic and digestive diseasesCommercial opportunity in metabolic and digestive diseases for HTD1801 and ourpipeline of other highly differentiated therapeutic candidatesR&D capabilities bolstered by visionary management team and world-renowned keyopin
150、ion leaders with deep expertise in metabolic and digestive diseasesTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 9 STRATEGIESWe plan to pursue the following opp
151、ortunities and execute our key strategies accordingly:Rapidly advance our current pipeline of drug candidates through clinicaldevelopment,and continue to expand indication coverage to maximize thetherapeutic and economic value of our assetsLeverage our drug discovery capabilities and team expertise
152、to build a pipeline basedon the multi-mechanism approachExpand our R&D team and capabilitiesPursue strategic collaboration in drug development and commercialization in theglobal marketStrategically seek partnerships to drive long-term growthContinue to protect our global IP by employing various life
153、-cycle management patentstrategies including a new molecular entity(a“composition-of-matter”patent),theprocess used to manufacture the drug,how the drug is used,and new formulations ofthe drug to protect our assets and maintain the market exclusivityRESEARCH AND DEVELOPMENTAs of the Latest Practicab
154、le Date,our drug discovery members have average 11 yearsexperience.We have worked on our product candidatesadvancement for more than 10 years anddeveloped product candidates in-house.Our drug discovery team members have expertise inbiology,medicinal chemistry,drug metabolism and pharmacokinetics(“DM
155、PK”),chemistry andearly clinical areas,which support our product development,and all of them have obtainedpost-graduate degrees.Our drug discovery comprises(i)identifying unmet medical needs and integratingreal-world data,network pharmacology,known and established molecules with desired therapeuticb
156、enefits to design novel,multifunctional drug candidates;(ii)performing in vitro and in vivoassays of drug candidates including but not limited to pharmacological activities,pharmacokinetics and toxicities;and(iii)developing formulations,and analytical assays forquality control and assurance.During t
157、he drug discovery stage,our R&D chemistry team carriesout synthesis and optimization of the target molecules for potential drug candidates.During thedrug evaluation stage,our drug discovery team coordinates and accomplishes preclinical R&Dactivities in relation to the product candidatespharmacology,
158、pharmacokinetics and toxicology.THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 10 As of the Latest Practicable Date,the clinical development team consisted of 30
159、 members,including scientists and physicians with strong drug development experience,who participate inclinical development strategy development,clinical trial protocol design,clinical trial operationorganization,drug safety monitoring,and clinical trial quality control.Our clinical developmentteam
160、members have average 11 yearsexperience.Among our clinical development team members,over 60%have obtained post-graduate degrees.Our clinical development staff represent a highlyskilled and experienced team of professionals who work collaboratively to design and executecomplex clinical trials and dru
161、g development programs.Our core capabilities in the area ofdevelopment include clinical trial design,regulatory and quality compliance,project management,clinical operations,medical writing,safety monitoring and drug development strategy.Our teamhas the expertise to design clinical trials that are r
162、igorous and compliant with regulatoryrequirements.This involves collaborating internally,with experts and regulatory authorities todetermine the appropriate patient population,defining endpoints,and selecting appropriate controlgroups.Our regulatory team has a thorough understanding of regulatory re
163、quirements for clinicaltrials in the relevant countries and regions,including knowledge of Good Clinical Practice(“GCP”)guidelines.The team has proven to be able to manage complex projects,includingclinical trials that involve multiple sites and stakeholders.This involves developing and managingtime
164、lines,budgets,and resources,as well as monitoring and mitigating risks.Lastly,the team hasthe strategic vision to guide drug development programs from early-stage research through clinicaldevelopment and regulatory approval.In line with industry practice,we collaborate with contract research organiz
165、ations(“CROs”)to conduct and support our preclinical and clinical studies.We select our CROs byweighing various factors,such as their qualifications,academic and professional experience,industry reputation and service fees.To the best of our Companys knowledge,all of our CROsduring the Track Record
166、Period are Independent Third Parties.In 2021 and 2022 and the six months ended June 30,2023,we recorded R&D costs ofRMB84.0 million,RMB182.7 million and RMB120.1 million,respectively,representing 62%,81%and 70%of total operating expenses in 2021,2022 and the six months ended June 30,2023,respectivel
167、y.In 2021 and 2022 and the six months ended June 30,2023,we recorded R&D costs ofRMB76.0 million,RMB173.7 million and RMB114.4 million,respectively,for our Core ProductHTD1801,representing 90.5%,95.1%and 95.2%of total R&D expenses in 2021,2022 and the sixmonths ended June 30,2023,respectively.THIS D
168、OCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 11 INTELLECTUAL PROPERTY RIGHTSAs of the Latest Practicable Date,we held 132 patents and patent applications,including 5
169、8patents and patent applications in relation to our Core Product.All of our material patents andpatent applications are self-owned.The following table sets forth an overview of our materialgranted patents and filed patent applications in connection with our Core Product as of the LatestPracticable D
170、ate:ProductName of Patent(1)JurisdictionStatusPatentExpiration(2)Marketcommercial rightsof the CompanyHTD1801.Berberine Salts,UrsodeoxycholicSalts and Combinations,Methods of Preparation andApplication ThereofAustralia,Brazil,Mainland China,EAPO,EPO,Israel,Japan,Korea,Mexico,Singapore,United States,
171、South Africa,Canada,India,New ZealandGranted2035OwnershipCanada,Mainland China,EAPO,Israel,Japan,Korea,Mexico,New Zealand,United StatesPendingOwnershipSolid Forms of BerberineUrsodeoxycholate andCompositions and MethodsThereofAustralia,Mainland China,EAPO,United StatesGranted2038(2037in MainlandChin
172、a)OwnershipAustralia,Canada,EPO,HongKong,Israel,Japan,Korea,New Zealand,United StatesPendingOwnershipCompositions of BerberineUrsodeoxycholate and MethodsThereof for Treating FattyLiver Disease,Diabetes and/orHyperlipidemia,and RelatedDiseases and DisordersUnited States,EPO,MainlandChinaPendingOwner
173、shipCompositions of BerberineUrsodeoxycholate and Methodsfor Treating PrimarySclerosing CholangitisUnited StatesPendingOwnershipAbbreviations:EPO=European Patent Office;PCT=Patent Cooperation Treaty;EAPO=Eurasian PatentOrganization.Notes:(1)Unless otherwise indicated,the patent for applications with
174、in the same family is the same and is thereforedisclosed once.(2)The patent expiration date is estimated based on current filing status,without taking into account anypossible patent term adjustments or extensions and assuming payment of all appropriate maintenance,renewal,annuity and other governme
175、nt fees.We conduct our business under the brand name of“HighTide”or“君聖泰.”As of the LatestPracticable Date,we held 34 trademarks and trademark applications in the United States,MainlandChina,Hong Kong,Europe and United Kingdom.We are also the owner of seven domain names.During the Track Record Period
176、 and up to the Latest Practicable Date,we had not been involved inany proceedings in respect of,and we had not received notice of any claims of infringement of,anyintellectual property rights,in which we may be a claimant or a respondent.To our best knowledge,we are not aware of any potential or mat
177、erial claims or disputes in relation to the infringement ofintellectual properties of our products during the Track Record Period.THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS D
178、OCUMENT.SUMMARY 12 LICENSING ARRANGEMENTS AND CONTINUING CONNECTED TRANSACTIONWe have entered into and will continue to engage in the below transaction which wouldconstitute continuing connected transaction for our Company under the Listing Rules followingcompletion of the REDACTED.We have applied t
179、o the Stock Exchange for,and the StockExchange has granted us,waivers from strict compliance with certain requirements set out inChapter 14A of the Listing Rules for such continuing connected transactions.For further details ofsuch potential non-exempt continuing connected transaction and the waiver
180、s,please see“Connected Transaction”.HTD1801 License-Out AgreementOn August 29,2020,we entered into a license-out agreement(“HTD1801 Agreement”)with Shenzhen Hepalink Pharmaceutical Group Co.,Ltd.(深圳市海普瑞藥業集團股份有限公司)(“Hepalink”)to promote the commercialization of innovative drug formulations containing
181、HTD1801 in Europe.Pursuant to the HTD1801 Agreement,we have granted Hepalink anexclusive,sublicensable(solely to Hepalinks wholly-owned subsidiaries),non-transferablelicense of HTD1801 for all aspects of commercialization for the indications of MASH and PSC inEurope,including,but not limited to,dist
182、ribution,dispensing,promotion,sales,branding,pricing,import,export and use of the product,use of the product name and packaging.We reserved therights to(i)research and develop HTD1801 worldwide;(ii)manufacture HTD1801 worldwide;(iii)commercialize HTD1801 for any indications outside Europe;(iv)commer
183、cialize HTD1801 inany region in Europe for indications other than for MASH and PSC;and(v)import and exportHTD1801 for the purposes described above.Hepalink is the owner of new intellectual propertyrights generated from the commercialization of HTD1801 by Hepalink.In consideration of the license gran
184、t,Hepalink shall pay milestone payments for variousdevelopment milestones for MASH and PSC,each ranging from RMB30.0 million to RMB50.0million.In addition,during the royalty term of HTD1801 in Europe,Hepalink is also obligated topay tiered royalty payments calculated as a percentage ranging from 10%
185、to 25%of total annualnet sales of HTD1801 in Europe.After expiration of the royalty term of HTD1801 in Europe,bothparties shall agree in advance on a separate written agreement regarding the sales royalties ifHepalink plans to continue sales of HTD1801,or continue to accrue sales royalties on thefor
186、egoing rates.The term of HTD1801 Agreement shall continue in full force until the date of expiration ofthe last applicable royalty term(the patent expiration date or the expiration date of regulatoryexclusion for other administrative protections,whichever is later),or the date of earliertermination,
187、whichever is earlier.For details,please refer to“Business CollaborationAgreement HTD1801 License-Out Agreement.”THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 13
188、 SUPPLIERSDuring the Track Record Period,our major suppliers primarily consisted of CROs,SMOsand CDMOs and we did not experience any material disputes with our suppliers.In addition,webelieve that adequate alternative sources for such supplies exist,and we have developed alternativesourcing strategi
189、es for these supplies.In 2021 and 2022 and the six months ended June 30,2023,our purchases from our five largest R&D suppliers in each year/period in aggregate amounted toRMB26.9 million,RMB68.7 million and RMB36.4 million,representing 45.5%,54.4%and 45.7%of our total corresponding purchases,respect
190、ively,and our purchases from the largest R&Dsupplier in each year/period accounted for 12.0%,17.9%and 26.5%of our total correspondingpurchases,respectively.All of our five largest suppliers during the Track Record Period are Independent ThirdParties.None of our Directors or any Shareholder who,to th
191、e knowledge of our Directors,ownsmore than 5%of our issued share capital immediately following completion of the REDACTED,nor any of their respective associates had any interest in any of our five largest suppliers during theTrack Record Period.MANUFACTURINGAs of the Latest Practicable Date,our CMC
192、team consisted of six professionals withextensive experience in process development,production and quality management fromwell-known biopharmaceutical and pharmaceutical companies.Our CMC team members have onaverage approximately eight years experience.Among our CMC team members,over 50%haveobtained
193、 post-graduate degrees.As of the Latest Practicable Date,we had not established an internal clinical manufacturingfacility.Collaborating with leading CDMOs,we currently outsource the production of productcandidates to support global clinical trials.Given the highly sophisticated nature of the drugsu
194、bstance and drug product manufacturing process,we support our CDMOs with our extensiveCMC know-hows in production,packaging,transportation,and storage of our products throughtechnology transfer.We have a stable relationship with our major CDMOs for more than five years,in particular,the CDMO providi
195、ng APIs for HTD1801.To the best of our Companys knowledge,none of CDMOs,including their shareholders,directors and senior management,have any past orpresent relationships with our Group,our Directors,shareholders,senior management or any oftheir respective associates.After market launch of our drug
196、candidates,we plan to continue tooutsource our commercial-scale manufacturing to globally recognized CDMOs.SHAREHOLDING OF AIC GROUP AND HEPALINK ENTITIESAs of the Latest Practicable Date,our single largest group of Shareholders comprised Dr.Liu,the Founder BVI,Greaty Investment,ZT Global Energy and
197、 Orient Champion(collectively,the“AIC Group”),each of which is a party to the Concert Party Agreement,which provided that(i)such parties had acted in concert since September 1,2019 and would continue to act in concertand collectively for all matters relating to the operation and development of our G
198、roup that need tobe approved by the Shareholders pursuant to applicable laws and the constitutional documents ofour Company after the REDACTED,and(ii)when and if they could not reach unanimousconsent,the decision of Dr.Liu shall prevail.Prior to REDACTED,the shareholdings of AICTHIS DOCUMENT IS IN D
199、RAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 14 Group and Hepalink entities in our Company are approximately 30.84%and 24.06%,respectively.Upon REDACTED,the shareholdings of AIC Gr
200、oup and Hepalink entities in our Company areapproximately REDACTED%and REDACTED%,respectively.Immediately after the REDACTED,Dr.Liu will abstain from voting on theREDACTED(REDACTED as adjusted after the REDACTED)unvested Shares held in the2020 ESOP Platform for the purpose of compliance with Rule 17
201、.05A of the Listing Rules.As aresult,the exercisable voting rights of the AIC Group and the Hepalink Entities in our Companywill not be equal to their respective shareholding in our Company upon REDACTED.For detailsof the exercisable voting rights of the AIC Group and the Hepalink Entities,please re
202、fer to“History,Reorganization and Corporate Structure Shareholding and Voting Rights of AICGroup and Hepalink Entities”.Upon REDACTED,the day-to-day management and operation of the Group will remain tobe driven by the executive Directors and the senior management under Dr.Lius leadership as thefound
203、er,chief executive officer,executive Director and chairwoman of the Board.Therefore,theAIC Group will continue to have day-to-day control over the management and operation of ourGroup upon REDACTED,while the designated director from Hepalink Entities remains anon-executive Director of the Company wh
204、o will not involve in the day-to-day management of ourCompany.For further details,see“History,Reorganization and Corporate Structure Day-to-DayControl over Management and Operation of the Group before and after the REDACTED”.OUR REDACTED INVESTORSWe have received seven rounds of REDACTED investments
205、 with an aggregate amount ofRMB12,000,000 and USD188,316,000 raised since our establishment.Our REDACTEDInvestors include Hepalink,Qianhai Haichuang,Goldlink,Able Holdings,Yuexiu Jinchan IV,Pingtan Rongjing and Yuthai Investment,MPCAPITAL,Greaty Investment,ZT Global Energy,Green Pine,Orient Champion
206、,Blue Ocean and Shenzhen BioResearch,Shenzhen Taixun,PolyPlatinum and Greater Bay Area Fund,HK Tigermed and Hangzhou Tigermed,Pluto and CITIC,Xinyu Cowin,Shenzhen Winzac,Sichuan Rongxin,Ningbo Borui,Hongtu Capital,BAIYI Capitaland Traditional Chinese Medicine Fund.Our REDACTED Investors include two
207、SophisticatedInvestors,namely,Greater Bay Area Fund and Traditional Chinese Medicine Fund,which will holdapproximately REDACTED%and REDACTED%respectively,of the total issued Shares ofthe Company upon the completion of the REDACTED(assuming that the REDACTED is notexercised).The Shares held by each o
208、f the Sophisticated Investors will be subject to lock-up for aperiod of six months commencing from the REDACTED.We utilize the proceeds from theREDACTED Investments to finance our research and development activities and fund our dailyoperations.For further details of the identity and background of o
209、ur REDACTED Investors,andthe principal terms of the REDACTED Investments,see“History,Reorganization and CorporateStructure REDACTED Investments.”THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE
210、COVER OF THIS DOCUMENT.SUMMARY 15 SUMMARY OF KEY FINANCIAL INFORMATIONSummary of Consolidated Statements of Profit or Loss and Other Comprehensive IncomeThe following table sets forth a summary of our consolidated statements of profit or loss andother comprehensive income for the years indicated.Our
211、 historical results presented below are notnecessarily indicative of the results that may be expected for any future period.During the TrackRecord Period and as of the Latest Practicable Date,we had not generated any revenue.For the year endedDecember 31,For the six months endedJune 30,2021202220222
212、023(unaudited)(RMB in thousands)Other income and gains.13,82120,5813,92522,722Fair value(losses)/gains on convertibleredeemable preferred shares.(93,656)23,24231,247(399,635)Other expenses.(1)(7,518)(4,381)(502)Fair value losses on financial liabilities atFVTPL.(4,609)Research and development costs.
213、(84,012)(182,651)(76,322)(120,088)Administrative expenses.(48,064)(43,433)(28,357)(52,014)Finance costs.(4,528)(426)(217)(201)Loss before tax.(221,049)(190,205)(74,105)(549,718)Total comprehensive loss for the year/period.(217,410)(223,888)(92,387)(586,343)We have incurred operating losses during th
214、e Track Record Period.Our loss before tax wasRMB221.0 million,RMB190.2 million and RMB549.7 million for 2021,2022 and the six monthsended June 30,2023,respectively.Substantially all of our loss resulted from fair value losses onconvertible redeemable preferred shares,research and development costs a
215、nd administrativeexpenses,as a result of the expansion of our business operations.Our research and development costs increased by 57.3%from RMB76.3 million in the sixmonths ended June 30,2022 to RMB120.1 million in the six months ended June 30,2023.Ourresearch and development costs increased by 117.
216、4%from RMB84.0 million in 2021 to RMB182.7million in 2022.The increase was primarily attributable to an increase in expenditures for ourclinical and preclinical development activities,including increase in third-party contractingexpenses,staff costs and ESOP expenses.THIS DOCUMENT IS IN DRAFT FORM,I
217、NCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 16 We recorded fair value gains on convertible redeemable preferred shares of RMB31.2million in the six months ended June 30,2022 and fair value l
218、osses on convertible redeemablepreferred shares of RMB399.6 million in the six months ended June 30,2023,mainly due to theincrease in fair value of our convertible redeemable preferred shares as of June 30,2023.Werecorded fair value losses on convertible redeemable preferred shares of RMB93.7 millio
219、n in 2021mainly because of the increase in fair value of Series B+convertible redeemable preferred sharesas of December 31,2021 compared with December 31,2020.We recorded fair value gains onconvertible redeemable preferred shares of RMB23.2 million in 2022 mainly because of thedecrease in fair value
220、 of Series B+and C convertible redeemable preferred shares as of December31,2022 compared with December 31,2021,resulting from the issuance of Series C+convertibleredeemable preferred shares in 2022,which retained with more preferential rights.For more details,see“Financial Information Description o
221、f Certain Key Items of theConsolidated Statements of Profit or Loss and Other Comprehensive Income.”Summary of Consolidated Statements of Financial PositionThe following table sets forth a summary of our consolidated statements of financialposition for the years indicated.As of December 31,As of Jun
222、e 30,202120222023(RMB in thousands)Total non-current assets.3,4504,8065,263Total current assets.775,182851,018753,319Total assets.778,632855,824758,582Total current liabilities.28,5341,319,720310,888Total non-current liabilities.1,022,3606,6321,476,120Total liabilities.1,050,8941,326,3521,787,008Net
223、 liabilities.(272,262)(470,528)(1,028,426)Net current assets/(liabilities).746,648(468,702)442,431THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 17 As of June 30
224、,2023,we maintained a net liabilities position,primarily due to therecognition of convertible redeemable preferred shares issued to investors as our non-currentliabilities.We had net liabilities of RMB272.3 million,RMB470.5 million and RMB1,028.4million as of December 31,2021 and 2022,and June 30,20
225、23,respectively.The increase in our netliabilities was primarily due to the increase in total comprehensive loss.Our total comprehensiveloss increased from RMB217.4 million in 2021 to RMB223.9 million in 2022 and our totalcomprehensive loss increased from RMB92.4 million for the six months ended Jun
226、e 30,2022 toRMB586.3 million for the six months ended June 30,2023.The increase in total comprehensiveloss was driven by the expanded research and development activities,fair value changes onconvertible redeemable preferred shares issued to investors,as well as administrative expenses.The majority o
227、f our convertible redeemable preferred shares was reclassified from currentliabilities as of December 31,2022,to non-current liabilities as of June 30,2023,as we enteredinto the supplementary deferred redemption agreement with majority of our investors of series B+,series C and series C+convertible
228、redeemable preferred shares.All preferred shares will bereclassified from financial liabilities to equity as a result of the automatic conversion into ourShares upon REDACTED,which will reverse our net liability position to a net asset position.See the AccountantsReport set out in Appendix I to this
229、 document for a detailed description of ourstatements of changes in equity.We had net current liabilities of RMB468.7 million as of December 31,2022,as comparedto net current assets of RMB442.4 million as of June 30,2023.This was mainly attributable to ourconvertible redeemable preferred share recla
230、ssification from short-term to long-term liabilities asof June 30,2023.We had net current assets of RMB746.6 million as of December 31,2021,ascompared to net current liabilities of RMB468.7 million as of December 31,2022.This was mainlyattributable to an RMB1,260 million increase in convertible rede
231、emable preferred shares which isprimarily due to reclassification of our convertible redeemable preferred shares from long-term toshort-terms liabilities.The convertible redeemable preferred shares will be re-classified as equityas the convertible redeemable preferred shares will automatically conve
232、rt into Shares uponREDACTED,after which we do not expect to recognize any further loss or gain on fair valuechanges from the convertible redeemable preferred shares.See the AccountantsReport set out inAppendix I to this document for a detailed description of our statements of changes equity.For more
233、 details,see“Financial Information Description of Certain Selected Items fromthe Consolidated Statements of Financial Position.”THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOC
234、UMENT.SUMMARY 18 Summary of Consolidated Statements of Cash FlowsThe following table sets forth the components of our consolidated statements of cash flowsfor the years indicated.For the year ended December 31,For the six months ended June 30,2021202220222023(unaudited)(RMB in thousands)Net cash flo
235、ws used inoperating activities.(90,546)(172,379)(74,419)(143,908)Net cash flows from/(used in)investing activities.1,588(415,661)2,749271,034Net cash flows from financingactivities.493,98246,034845(1,946)Net increase/(decrease)incash and cash equivalents.405,024(542,006)(70,825)125,180Cash and cash
236、equivalents atbeginning of year.367,252765,290765,290273,047Effects of foreign exchange ratechanges,net.(6,986)49,76329,29019,671Cash and cash equivalents atend of year.765,290273,047723,755417,898In the six months ended June 30,2023,our net cash used in operating activities wasRMB143.9 million.This
237、 net outflow from operating activities primarily reflected loss before tax ofRMB549.7 million,positively adjusted primarily by(i)fair value losses on convertible redeemablepreferred shares of RMB399.6 million,(ii)equity-settled share option arrangements of RMB28.4million and(iii)an increase in trade
238、 payables of RMB8.1 million,partially offset by(i)an increasein prepayments,other receivable and other assets of RMB8.4 million and(ii)a decrease in otherpayables and accruals of RMB6.3 million.In 2022,our net cash used in operating activities was RMB172.4 million.This net outflowfrom operating acti
239、vities primarily reflected loss before tax of RMB190.2 million,positivelyadjusted primarily by(i)equity-settled share option arrangements of RMB25.6 million and(ii)foreign exchange differences,net of RMB7.5 million.The amount was further adjusted by changesin working capital,primarily including(i)an
240、 increase in trade payables of RMB15.6 million and(ii)an increase in other payables and accruals of RMB13.5 million,partially offset by a decrease indeferred income of RMB3.9 million.THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION W
241、ITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 19 In 2021,our net cash used in operating activities was RMB90.5 million.This net outflowfrom operating activities primarily reflected loss before tax of RMB221.0 million,positivelyadjusted primarily by(i)fair value losses on conve
242、rtible redeemable preferred shares of RMB93.7million and(ii)transaction costs for preferred shares of RMB16.2 million.This amount wasfurther adjusted by changes in working capital,primarily including(i)an increase in otherpayables and accruals of RMB14.4 million and(ii)an increase in deferred income
243、 of RMB3.4million,partially offset by an increase in prepayments,other receivables and other assets ofRMB3.6 million.In 2022,our net cash used in investing activities was RMB415.7 million,which wasprimarily attributable to purchase of financial assets at FVTPL of RMB717.8 million and purchaseof shor
244、t-term time deposits of RMB621.4 million,partially offset by proceeds from disposal offinancial assets at FVTPL of RMB717.8 million,proceeds from disposal of short-term timedeposits of RMB197.5 million,receipts of investment income from short-term time deposits ofRMB3.9 million and bank interest rec
245、eived of RMB3.5 million.Our cash burn rate refers to our average monthly(i)net cash used in operating activities,(ii)capital expenditures and(iii)lease payments.Assuming an average cash burn rate going forward of2.1 times the level in 2022,we estimate that our total cash balance as of June 30,2023,w
246、ill be ableto maintain our financial viability for approximately 25 months or,if taking into account theestimated net REDACTED(based on the mid-point of the indicative REDACTED andassuming the REDACTED is not exercised)from the REDACTED,for at least REDACTED.We will continue to monitor our cash flow
247、s from operations closely and expect to raise our nextround of financing,if needed,with a minimum buffer of 12 months.Key Financial RatiosAs of December 31,As of six months ended June 30,2021202220222023(unaudited)Gearing Ratio(1).(3%)(2%)(2%)(1%)Current Ratio(2).27.20.60.72.4Notes:(1)Equals bank lo
248、ans and other borrowings divided by total equity as of the same date.(2)Equals current assets divided by current liabilities as of the same date.THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE
249、COVER OF THIS DOCUMENT.SUMMARY 20 REDACTEDDIVIDENDWe have never declared or paid regular cash dividends on our Shares.Any declaration andpayment as well as the amount of dividends will be subject to our Memorandum and Articles andthe Cayman Companies Act.Our Board of Directors has the discretion to
250、pay interim dividendsand to recommend to Shareholders to pay final dividends,and will depend on a number of factors,including our earnings,capital requirements,overall financial condition and contractualrestrictions.In addition,our Shareholders in a general meeting may approve any declaration ofdivi
251、dends,which must not exceed the amount recommended by our Board.As advised by ourCayman counsel,under the Cayman Companies Act,a Cayman Islands company may pay adividend out of either profits and/or share premium account,provided that in no circumstancesmay a dividend be paid out of share premium if
252、 this would result in the company being unable topay its debts as they fall due in the ordinary course of business.In light of our accumulated lossesas disclosed in this document,it is unlikely that we will be eligible to pay a dividend out of ourprofits in the foreseeable future.We may,however,pay
253、a dividend out of our share premiumaccount unless the payment of such a dividend would result in our Company being unable to payour debts as they fall due in the ordinary course of business.There is no assurance that dividends ofany amount will be declared to be distributed in any year.THIS DOCUMENT
254、 IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 21 If we pay dividends in the future,in order for us to distribute dividends to our Shareholders,we will rely to some extent on
255、 any dividends distributed by our PRC subsidiaries.Any dividenddistributions from our PRC subsidiaries to us will be subject to PRC withholding tax.In addition,regulations in the PRC currently permit payment of dividends of a PRC company only out ofaccumulated distributable after-tax profits as dete
256、rmined in accordance with its articles ofassociation and the accounting standards and regulations in China.See“Risk Factors RisksRelating to Doing Business in the PRC”in this document.USE OF REDACTEDWe estimate that we will receive net REDACTED of approximately HK$REDACTEDafter deducting the REDACTE
257、D fees and expenses payable by us in the REDACTED,assumingnoexerciseoftheREDACTEDandassuminganREDACTEDofHK$REDACTED per REDACTED,being the midpoint of the indicative REDACTED rangeof HK$REDACTED to HK$REDACTED per REDACTED in this document.We intend touse the net REDACTED from the REDACTED for the f
258、ollowing purposes:Approximately HK$REDACTED,representing REDACTED%of the netREDACTED,will be used to fund the continuing clinical development activities aswell as registration filings,post-approval studies and costs and expenses of R&D staffand activities of our Core Product HTD1801;Approximately HK
259、$REDACTED,representing REDACTED%of the netREDACTED,will be used to fund the ongoing research and development as well asR&D personnel costs,drug production for the clinical studies and contracting costswith third parties of our product candidate HTD1804 for obesity.We are currentlyconducting the prec
260、linical study of HTD1804 in China;Approximately HK$REDACTED,representing REDACTED%of the netREDACTED,will be used for the early drug discovery and development of otherdrug candidates and the enhancement of FUSIONTX development approach;Approximately HK$REDACTED,representing REDACTED%of the netREDACT
261、ED,will be used for working capital and other general corporatepurposes.For further details,see“Future Plans and Use of REDACTED.”RISK FACTORSWe believe that there are certain risks involved in our operations,many of which are beyondour control.These risks are set out in the section headed“Risk Fact
262、ors”in this document.Some ofthe major risks we face include:The Core Product may fail to meet the primary and secondary endpoints at thelate-stage clinical trials due to higher clinical development risks resulted fromHTD1801 being a new molecular entity and potential rejection from competentauthorit
263、ies.THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 22 Clinical drug development involves a lengthy and expensive process with uncertainoutcomes,and we may be una
264、ble to commercialize our drug candidates at all.If our drug candidates fail to demonstrate safety and efficacy to the satisfaction ofregulatory authorities or do not otherwise produce positive results,we may incuradditional costs or experience delays in completing,or may ultimately be unable tocompl
265、ete,the development and commercialization of our drug candidates.If we lose the Fast Track Designation or the Orphan Drug Designation by the FDA forour drug candidates,the time and cost we incur to obtain regulatory approvals mayincrease.The regulatory approval processes of the NMPA,FDA,EMA and othe
266、r comparableregulatory authorities are time-consuming and may evolve over time,and if we areultimately unable to obtain regulatory approval for our drug candidates,our businesswill be substantially harmed.We work with third parties to manufacture a portion of our drug candidates forclinical developm
267、ent and commercial sales.Our business could be harmed if thosethird parties fail to deliver sufficient quantities of products or fail to do so atacceptable quality levels or prices.We have incurred significant net losses since inception and we may continue to incurnet losses and may fail to achieve
268、or maintain profitability in the future.As a result,you may lose substantially all of your REDACTED in us if our business fails.We could be unsuccessful in obtaining or maintaining adequate patent protection forone or more of our drug candidates through intellectual property rights,or if the scopeof
269、 such intellectual property rights obtained is not sufficiently broad,third partiesmay compete directly against us.The market size of our drug candidates might be smaller than we expected.REDACTEDOur REDACTED represent professional fees,REDACTED and other fees incurred inconnection with the REDACTED
270、.Assuming an REDACTED of HK$REDACTED per Shareat the mid-point of the indicative REDACTED range stated in this document and noREDACTED is exercised,we estimated that the total REDACTED for the REDACTED areapproximately HK$REDACTED,accounting for approximately REDACTED%of the grossREDACTED from the R
271、EDACTED,including HK$REDACTED that we have incurred forthe years ended December 31,2021 and 2022 and the six months ended June 30,2023,of whichHK$REDACTED was charged to our consolidated statements of profit or loss,while theremaining amount of HK$REDACTED was directly attributable to the issue of S
272、hares as of June30,2023 and will be subsequently deducted from equity upon completion of the REDACTED,and HK$REDACTED that we expect to further incur after June 30,2023,of whichHK$REDACTEDwillbechargedtoourconsolidatedincomestatements,andTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANG
273、E AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 23 HK$REDACTED is expected to be accounted for as a deduction from equity upon thecompletion of REDACTED.The above expenses comprise of(i)REDACTED-relatedexpenses,including RED
274、ACTED and other expenses,of HK$REDACTED;and(ii)non-REDACTED-related expenses of HK$REDACTED,including(a)fee paid and payable tolegal advisors and reporting accountants of HK$REDACTED,and(b)other fees and expenses ofHK$REDACTED.The REDACTED above are the latest practicable estimate for referenceonly,
275、and the actual amount may differ from this estimate.RECENT DEVELOPMENTSImpact of the COVID-19 OutbreakThe outbreak of the COVID-19 and its recurrence had caused temporary disruption to ouroperations to the extent that certain on-site meetings,deployment and technical support had to bedelayed or canc
276、elled.As of the Latest Practicable Date,however,COVID-19 had not had anymaterial adverse impact on our R&D activities,clinical development,daily operation,supply chainand regulatory affairs.Given that the PRC government has substantially lifted its COVID-19prevention and control policies since Decem
277、ber 2022,our Directors are of the view that it isunlikely that the COVID-19 will have a material adverse impact on our business going forward.Recent Developments in Clinical DevelopmentFor MASH,we initiated our Phase IIb study(HTD1801.PCT014)in the United States inDecember 2022 and in Hong Kong in O
278、ctober 2023,and we are actively enrolling patients in thisstudy in the United States and Hong Kong.We obtained the IND approval from the NMPA inMainland China in September 2023.In July 2023,we submitted an IND application to initiatePhase IIb study(HTD1801.PCT014)for MASH with T2DM or prediabetes in
279、 Mexico.We expectto initiate the same study in Mexico and Mainland China in December 2023.For T2DM,we initiated Phase II study(HTD1801.PCT103)in China in March 2022 andcompleted in January 2023 with 113 patients enrolled.The Phase II clinical trial has demonstrateda strong therapeutic effect in impr
280、oving glucose metabolism,including statistically significantdecreases in HbA1c and fasting glucose levels,which may be the result of decreased insulinresistance.In the clinical trial,improvements in other disease-relevant parameters were alsoobserved.With HTD1801 treatment,liver biomarkers(ALT,AST,G
281、GT)were reduced.HTD1801also led to improvement of lipid profiles,such as reduction of low-density lipoprotein cholesterol(“LDL-c”)and non-high-density lipoprotein cholesterol(“non-HDL-c”)levels.In November2023,we initiated the two Phase III clinical trials(i.e.one with HTD1801 as a standalonetreatme
282、nt and one with HTD1801 as an add-on therapy with metformin)for the T2DM indicationof our self-developed HTD1801 in China.We expect to complete those two Phase III studies in2025.For SHTG,in April 2023,the FDA concluded that the available clinical results from PhaseIb/IIa study for hypercholesterole
283、mia(HTD1801.PCT004)in Australia and completed Phase IIaMASH study in the United States(HTD1801.PCT012)were sufficient to support a Phase II studyin subjects with SHTG.We plan to file IND with the FDA to initiate the Phase II of HTD1801 forSHTG in the United States in the first half of 2024.THIS DOCU
284、MENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 24 Recent Regulatory DevelopmentsOn February 17,2023,the CSRC promulgated the Trial Administrative Measures ofOverseas Secu
285、rities Offering and Listing by Domestic Companies(境內企業境外發行證券和上市管理試行辦法)(the“Overseas Listing Trial Measures”)and relevant supporting guidelines,which came into effect on March 31,2023.The Overseas Listing Trial Measures comprehensivelyimprove and reform the existing regulatory regime for overseas off
286、ering and listing of PRCdomestic companiessecurities and regulate both direct and indirect overseas offering and listingof PRC domestic companiessecurities.Pursuant to the Overseas Listing Trial Measures,where a PRC domestic company submitsan application for initial public offering to competent over
287、seas regulators or overseas stockexchanges,such issuer must file with the CSRC within three business days after such application issubmitted.As advised by our PRC Legal Advisor,we are required to complete the filing with theCSRC pursuant to the Overseas Listing Trial Measures.We submitted required f
288、iling documents tothe CSRC on June 1,2023.On October 19,2023,the CSRC issued a notification on our Companyscompletion of the PRC filing procedures for the REDACTED of our Shares on the StockExchange.Expected Increase in Net LossWe expect to incur a significant increase in net loss for 2023 due to(i)
289、increase in fair valuelosses on convertible redeemable preferred shares,(ii)the anticipated costs associated withincreased research and development activities and(iii)expenses in connection with theREDACTED incurred in 2023.No Material Adverse ChangeOur Directors confirm that up to the date of this
290、document,save as disclosed above,therehas been no material adverse change in our financial,operational or trading positions or prospectssince June 30,2023,being the end of the period reported on as set out in the AccountantsReportincluded in Appendix I to this document.THIS DOCUMENT IS IN DRAFT FORM
291、,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.SUMMARY 25 In this document,unless the context otherwise requires,the following terms shallhave the meanings set out below.Certain other terms are expla
292、ined in the section headed“Glossary of Technical Terms”in this document.“2020 ESOP Platform”Wisdom Spring Group Limited“2020 Share Incentive Plan”the employee long term incentive plan originally adoptedby our Company on January 22,2020,amended andrestated on October 18,2021 and further amended andre
293、stated in its entirety on March 4,2022,the principalterms of which are set out in“Appendix IV Statutoryand General Information D.Incentive Plans 1.2020Share Incentive Plan”to this document“2023 ESOP Platform”Wisdom Summer Group Limited“2023 Share Incentive Plan”the employee long term incentive plan
294、adopted by ourCompany on May 24,2023,the principal terms of whichare set out in“Appendix IV Statutory and GeneralInformation D.Incentive Plans 2.2023 ShareIncentive Plan”to this document“AFRC”the Accounting and Financial Reporting Council“AIC Group”refers to Dr.Liu,the Founder BVI,Greaty Investment,
295、ZTGlobal Energy and Orient Champion“Articles of Association”or“Articles”the amended and restated articles of association of ourCompany conditionally adopted on,2023,and witheffect from the REDACTED,a summary of which is setout in Appendix III to this document,as amended fromtime to time“associate(s)
296、”has the meaning ascribed to it under the Listing Rules“Audit Committee”the audit committee of the Board“Australia HighTide”HIGHTIDE BIOPHARMA PTY.LTD.,a proprietarycompany limited by shares registered in Australia on July15,2015,and a subsidiary of our Company“Board”or“Board of Directors”the board
297、of directors of our Company“Business Day”a day on which banks in Hong Kong are generally open fornormal banking business to the public and which is not aSaturday,Sunday or public holiday in Hong KongTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ
298、IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.DEFINITIONS 26“BVI HighTide”HighTideTherapeutics,Ltd.,alimitedcompanyincorporatedintheBVIonMarch26,2018,awholly-owned subsidiary of our CompanyREDACTED“CCASS”the Central Clearing and Settlement System establishedand operate
299、d by HKSCC“CDE”the Center for Drug Evaluation of the NMPA(國家藥品監督管理局藥品審評中心),a division of the NMPA mainlyresponsible for the review and approval of IND and NDA“China”,“Mainland China”or“PRC”Peoples Republic of China,but for the purpose of thisdocument and for geographical reference only and exceptwhe
300、re the context requires otherwise,references in thisdocument to“China”and the“PRC”do not apply to HongKong,Macau and Taiwan“CIC”China Insights Industry Consultancy Limited,a globalmarket research and consulting company,which is anIndependent Third Party“close associate(s)”has the meaning ascribed th
301、ereto under the Listing Rules“Company”or“our Company”HighTide Therapeutics,Inc.,a company incorporatedunder the laws of the Cayman Islands with limited liabilityon February 28,2018“Companies(Winding Up andMiscellaneous Provisions)Ordinance”theCompanies(WindingUpandMiscellaneousProvisions)Ordinance(C
302、hapter 32 of the Laws of HongKong)as amended,supplemented or otherwise modifiedfrom time to time“Companies Act”or“CaymanCompanies Act”the Companies Act,Cap.22(As Revised)of the CaymanIslandsTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUN
303、CTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.DEFINITIONS 27“Companies Ordinance”the Companies Ordinance(Chapter 622 of the Laws ofHong Kong)as amended,supplemented or otherwisemodified from time to time“connected person(s)”has the meaning ascribed thereto under the Listing Rul
304、es“connected transaction(s)”has the meaning ascribed thereto under the Listing Rules“core connected person(s)”has the meaning ascribed thereto under the Listing Rules“Core Product”has the meaning ascribed to it in Chapter 18A of the ListingRules;for the purpose of this document,our Core Productrefer
305、s to HTD1801“COVID-19”disease caused by a new strain of coronavirus where COstands for corona,VIfor virus,and Dfor disease“CSRC”China Securities Regulatory Commission(中國證券監督管理委員會)“Director(s)”or“our Director(s)”the directors of our Company,including all executive,non-executive and independent non-ex
306、ecutive Directors“Dr.Liu”Dr.LIU Liping(劉利平),the founder,executive Directorand chief executive officer of our Company“EIT Law”the PRC Enterprise Income Tax Law(中華人民共和國企業所得稅法),as enacted by the NPC on March 16,2007 andeffective on January 1,2008,as amended,supplemented orotherwise modified from time t
307、o time“EMA”the European Medicines Agency“ESOP Platforms”the 2020 ESOP Platform and the 2023 ESOP Platform“Extreme Conditions”extreme conditions caused by a super typhoon asannounced by the Government of Hong Kong“Family Trust”an irrevocable discretionary trust settled by Dr.Liu as thesettlor pursuan
308、t to a trust deed dated December 31,2020under the laws of the State of Delaware for her successionplanning,and pursuant to the aforesaid trust deed,thebeneficiary is any one or more of Dr.Lius children andmore remote issue“FDA”the United States Food and Drug AdministrationTHIS DOCUMENT IS IN DRAFT F
309、ORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.DEFINITIONS 28 REDACTED“Founder BVI”GREAT Mantra Group Limited,a limited companyincorporated in the BVI on November 24,2017,one of themembers of the
310、AIC Group and wholly-owned by theFamily TrustREDACTED“Group”or“our Group”our Company and all of our subsidiaries or,where thecontext so requires,in respect of the period before ourCompany became the holding company of its presentsubsidiaries,the businesses operated by such subsidiariesor their prede
311、cessors(as the case may be)“Hebei Puhui”Hebei Puhui Pharmaceutical Co.,Ltd.(河北普惠醫藥有限公司),a limited liability company established in the PRCon September 27,2023,a wholly-owned subsidiary of ourCompany“Hepalink”Shenzhen Hepalink Pharmaceutical Group Co.,Ltd.(深圳市海普瑞藥業集團股份有限公司),a joint stock limitedcompa
312、ny incorporated under the laws of the PRC,whose Ashares are listed on the Shenzhen Stock Exchange(stockcode:002399)and H Shares are listed on the StockExchange(stock code:9989)“HK$”or“Hong Kong Dollars”or“HKD”Hong Kong dollars,the lawful currency of Hong Kong“HK HighTide”HighTide Therapeutics(Hong K
313、ong)Limited,a limitedcompany incorporated in Hong Kong on April 9,2018,awholly-owned subsidiary of our Company“HKSCC”Hong Kong Securities Clearing Company Limited,awholly-owned subsidiary of Hong Kong Exchanges andClearing LimitedTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND TH
314、AT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.DEFINITIONS 29 REDACTED“HKSCC Nominees”HKSCC Nominees Limited,a wholly-owned subsidiary ofHKSCC“Hong Kong”the Hong Kong Special Administrative Region of the PRCREDACTED“Hong Kong Stock Exchang
315、e”or“Stock Exchange”TheStockExchangeofHongKongLimited,awholly-owned subsidiary of Hong Kong Exchange andClearing Limited“Hong Kong Takeovers Code”or“Takeover Code”the Codes on Takeovers and Mergers and Share Buy-backsissued by the SFC,as amended,supplemented or otherwisemodified from time to timeRED
316、ACTEDTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.DEFINITIONS 30 REDACTED“Incentive Plans”the 2020 Share Incentive Plan and the 2023 Share IncentivePlan“Independent Th
317、ird Party(ies)”party or parties that,to the best of our Directorsknowledge,information and belief,having made allreasonable enquiries,is or are not a connected person orconnected persons of the Company within the meaning ofthe Listing RulesREDACTEDTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJEC
318、T TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.DEFINITIONS 31 REDACTED“Joint Sponsors”UBS Securities Hong Kong Limited and Huatai FinancialHoldings(Hong Kong)Limited“JSK Healthcare”JSK Consumer Healthcare,Ltd.(深圳君聖康生物技術有限
319、公司),a limited liability company established in thePRC on July 21,2015,a wholly-owned subsidiary of ourCompany“Latest Practicable Date”November 27,2023,being the latest practicable date forthe purpose of ascertaining certain information containedin this document prior to its publicationREDACTED“Listi
320、ng Committee”the listing committee of the Hong Kong Stock ExchangeREDACTED“Listing Rules”the Rules Governing the Listing of Securities on The StockExchange of Hong Kong Limited,as amended orsupplemented from time to time“M&A Rules”Regulations on Mergers and Acquisitions of DomesticCompanies by Forei
321、gn Investors(關於外國投資者併購境內企業的規定),which were jointly promulgated byMOFCOM,theStateAssetsSupervisionandAdministration Commission,the SAT,the SAIC,theCSRC,and the SAFE on August 8,2006,and came intoeffect on September 8,2006 and subsequently amended onJune 22,2009,as amended,supplemented or otherwisemodi
322、fied from time to time“Main Board”the stock exchange(excluding the option market)operatedby the Stock Exchange which is independent from andoperated in parallel with the GEM of the Stock Exchange.THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN
323、CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.DEFINITIONS 32“Memorandum”or“Memorandumof Association”the amended and restated memorandum of association ofour Company conditionally adopted on 2023 witheffect from the REDACTED,a summary of which is setout in Appendix III to
324、this document,as amended fromtime to time“MOFCOM”or“Ministry ofCommerce”the Ministry of Commerce of the PRC(中華人民共和國商務部)“Nanchang Fusion”Nanchang Fusion Therapeutics,Ltd.(南昌福藥生物技術有限公司),a limited liability company established in thePRC on November 29,2021,a wholly-owned subsidiary ofour Company“Nation
325、al Bureau of Statistics”the National Bureau of Statistics of China(中華人民共和國國家統計局)“NDRC”the National Development and Reform Commission of thePRC(中華人民共和國國家發展和改革委員會)“NHFPC”National Health and Family Planning Commission(國家衛生和計劃生育委員會)“NMPA”National Medical Products Administration(國家藥品監督管理局)and its predece
326、ssor,the China Food and DrugAdministration(國家食品藥品監督管理總局)from 2013to 2018 and the State Food and Drug Administration(國家食品藥品監督管理局)from 2003 to 2013“Nomination Committee”the nomination committee of the Board“Non-PRC Resident Enterprise”as defined under the EIT Law,means companiesestablished pursuant to
327、 a non-PRC law with their de factomanagement conducted outside the PRC,but which haveestablished organizations or premises in the PRC,or whichhave generated income within the PRC without havingestablished organizations or premises in the PRC“NPC”the National Peoples Congress of the PRC(中華人民共和國全國人民代表
328、大會)THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.DEFINITIONS 33 REDACTED“PBOC”the Peoples Bank of China(中國人民銀行),the centralbank of the PRC“PRC Legal Advisor”Han Kun Law
329、 Offices“Preferred Shares”the Series A Preferred Shares,the Series B-1 PreferredShares,the Series B-2 Preferred Shares,the Series B+Preferred Shares,the Series C Preferred Shares and theSeries C+Preferred Shares“REDACTED Investments”certain rounds of financing carried out by the Group beforethe REDA
330、CTED,details of which are set out in thesection headed“History,Reorganization and CorporateStructure REDACTED Investments”in this document“REDACTED Investors”The investors of the REDACTED InvestmentsREDACTEDTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUST
331、BE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.DEFINITIONS 34 REDACTED“QIB”qualified institutional buyer within the meaning of Rule144A“Regulation S”Regulation S under the U.S.Securities Act“Remuneration Committee”the remuneration committee of the Board“Renminbi
332、”or“RMB”the lawful currency of the PRC“Reorganization”the reorganization conducted by our Group in preparation forthe REDACTED as described in the section headed“History,Reorganization and Corporate Structure Reorganization”in this document“Rule 144A”Rule 144A under the United States Securities Act“
333、SAFE”the State Administration of Foreign Exchange of the PRC(中華人民共和國國家外匯管理局)“SAIC”the State Administration of Industry and Commerce of thePRC(中華人民共和國國家工商行政管理總局)“SAT”the State Administration of Taxation of the PRC(中華人民共和國國家稅務總局)“Series A Preferred Shares”the series A preferred shares of our Company with a parvalue of US$0.0001 each“Series B-1 Preferred Shares”the series B-1 preferred shares of our
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