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类型智慧芽:Sotorasib药物报告(2022)(29页).pdf

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    智慧 Sotorasib 药物 报告 2022 29
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    1、 1/1 Copyright2022?(?)?Drug?Data?Report?Series?研?200+?&50+?2022?8?1400?+?6100?+?6.8?+?4.4?+?1?+?33?+?84?+?13?+?https:/?Web?Drug Data Report Series:Sotorasib 1 Copyright2022?(?)?1.?.?3?1.1!#$.3 1.2!%&.4 1.3()*.5 1.4+,-.5 1.5/012.6 1.6 3456789:.6 1.7;?.6 2.?.?8?2.1 CMC#.8 2.2 Sotorasib ABCD.9 3.?.?11?

    2、3.1 E,FG.11 3.2!HI.11 3.3!JKLI.11 4.?.?14?4.1 MNOPMQROPSTLUV.14 4.2 KWXIY/Z!XI.14 5.?.?15?Drug Data Report Series:Sotorasib 2 Copyright2022?(?)?5.1 _abc.17 6.?.?21?7.?SOTORASIB?.?23?8.?SOTORASIB?.?24?Drug Data Report Series:Sotorasib 3 Copyright2022?(?)?Sotorasib?1.?Sotorasib?Lumakras?AMG-510?Amgen?

    3、first-in-class?KRAS-G12C?2021?5?28?FDA?KRAS-G12C?NSCLC?KRAS?2022?1?10?EMA?Sotorasib?Lumakras?AMG-510?1?KRAS?G12C?Sotorasib?KRAS-G12C?NSCLC?KRAS?/?NSCLC?KRAS-G12C?1.1!#$?Drug Data Report Series:Sotorasib 4 Copyright2022?(?)?3D?Structure?Pubchem?1.2!%&Sotorasib?AMG-510?KRAS?KRAS-G12C?Sotorasib?KRAS-G1

    4、2C?KRAS-G12C?KRAS-G12C?Sotorasib?120?mg?AMG?120?Sotorasib?Drug Data Report Series:Sotorasib 5 Copyright2022?(?)?1.3()*Sotorasib?120mg?960mg?8?/120mg?1.4+,-.1?Sotorasib?2?1?Sotorasib?3?4?Sotorasib?120mL?(?模?)?2?120mL?溶?5?4?10?Sotorasib?6?溶?Sotorasib?溶?6?7?研?导?Sotorasib?导?240mg?Sotorasib?480?(4?)?240?

    5、(2?)?Drug Data Report Series:Sotorasib 6 Copyright2022?(?)?1.5/012?Sotorasib?20?-25?1.6 3456789:Sotorasib?研?Sotorasib?研?Sotorasib?NCE?研 FDA?2028?5?28?1.7;?FDA?EMA?KRASG12C?(NSCLC)?Sotorasib?Drug Data Report Series:Sotorasib 7 Copyright2022?(?)?研?Drug Data Report Series:Sotorasib 8 Copyright2022?(?)?

    6、2.?2.1 CMC#?去?去?AMGAMG-510510?Sotorasib?Lumakras?120?mg?C30H30F2N6O3?CASCAS?2296729-00-3?560.6?g/mol?1.1?1.3?mg/mL?pH?1.2?/?0.03?mg/mL?pH?6.80?pKapKa?8.06,?4.56?BCSBCS?IV?FDA?214665Orig1s000?PRODUCT?QUALITY?REVIEW(S)?Drug Data Report Series:Sotorasib 9 Copyright2022?(?)?2.2 Sotorasib ABCD?Sotorasib?

    7、AMG-510?1?导?2?1b?告?3?DCM?3?41%?4?75?2-MeTHF?(+)-2,3-?-D-?4 导?模?20?M-dione?5M?37%?M-dione?5M?去?SNAr?去导?导?6?66%?6?6A?Suzuki?7?7?80%?boc-?导?8?94%?9A?Sotorasib?Drug Data Report Series:Sotorasib 10 Copyright2022?(?)?Sotorasib?WO2021097207A1/?WO2020232130A1?Improved?Synthesis?of?New?FDA-Approved?Treatment

    8、?for?KRAS?G12C?Mutation?in?Non-small?Cell?Lung?Cancer?American?Chemical?Society?2021?https:/doi.org/10.1021/acsmedchemlett.1c00330 Drug Data Report Series:Sotorasib 11 Copyright2022?(?)?3.?3.1 E,FG Sotorasib?KRAS?G12C?KRAS?G12C?KRAS?RAS?GTPase?Sotorasib?KRAS?G12C?尼?KRAS?Sotorasib?KRAS?G12C?KRAS?尼?So

    9、torasib?KRAS?G12C?Sotorasib?KRAS?G12C?Sotorasib?3.2 !HI?Sotorasib?QTc?(?20?ms)?3.3 !JKLI 溶?KRAS-G12C?NSCLC?Sotorasib?去?180?mg-960?mg?0.19?1?Sotorasib?去?AUC0-24?h?Cmax?Sotorasib?Sotorasib?22?Sotorasib?0.56?(CV)?59%?Drug Data Report Series:Sotorasib 12 Copyright2022?(?)?Sotorasib?1?800-1000?150?250?50

    10、0-600?960?mg?Sotorasib?Sotorasib?AUC0-24?h?25%?Sotorasib?(Vd)?211?L(CV?135%)?Sotorasib?89%?Sotorasib?5?(SD)?2?960?mg?Sotorasib?Sotorasib?26.2?L/h(CV?76%)?Sotorasib?去?CYP3A?去?sotorasib?74%?53%?6%?1%?28-86?千?(36.8-157.9?kg)?ECOG?PS(0?1)?(eGFR?30?mL/min/1.73?m2)?Sotorasib?去?AST?ALT?2.5ULN?1.5ULN?Sotora

    11、sib?去?Drug Data Report Series:Sotorasib 13 Copyright2022?(?)?Sotorasib?Sotorasib?Sotorasib?Sotorasib?Sotorasib?Sotorasib?Sotorasib?P-?H2?4?10?Sotorasib?CYP3A4CYP3A4?CYP3A4?CYP3A4CYP3A4?CYP3A?4?研?P P-gpgp?P-gp?研?Drug Data Report Series:Sotorasib 14 Copyright2022?(?)?4.?4.1 MNOPMQROPSTLUV?Sotorasib?So

    12、torasib?(Ames)?然?Sotorasib?/?4.2 KWXIY/Z!XI?Sprague-Dawley?960?mg?AUC?0.5?/?S-?-?去?去?3?Sotorasib?0.4?960?mg?AUC?导?告?溶?去?Drug Data Report Series:Sotorasib 15 Copyright2022?(?)?5.?副?KRAS?25%?NSCLC?13%?KRAS?G12C?Sotorasib?KRAS?G12C?KRAS?G12C?KRAS?KRAS?FDA?Sotorasib?CodeBreaK?I/II?千?千?124?/?KRAS?G12C?NS

    13、CLC?960?mg?Sotorasib?36%?95%?CI?28-45?81%?95%?CI?73-87?10?导?9%?Sotorasib?导?Drug Data Report Series:Sotorasib 16 Copyright2022?(?)?Sotorasib?I/II?研?NEJM?副?A?124?121?B?研?Sotorasib?46?Drug Data Report Series:Sotorasib 17 Copyright2022?(?)?C?研?124?Kaplan-Meier?D?126?Kaplan-Meier?EGFR?VEGFR?PI3K?,?副?,?岁?

    14、导?5.1 _abc?8?30?Sotorasib?KRAS?G12C?III?CodeBreaK?200?Sotorasib?PFS?KRAS?G12C?CodeBreaK?200?III?Lumakras?345?KRAS?G12C?(NSCLC)?Drug Data Report Series:Sotorasib 18 Copyright2022?(?)?CodeBreaK?200?研?Sotorasib?CodeBreaK?200?研?ESMO?Sotorasib?KRAS?G12C?KRAS-G12C?NSCLC?PFS?BICR?PFS?Sotorasib?5.6?4.5?HR0.

    15、66?P=0.002?12?PFS?Sotorasib?24.8%?10.1%?Sotorasib?ORR?DCR?TTR?DOR?告 OS?Sotorasib?导?导?Drug Data Report Series:Sotorasib 19 Copyright2022?(?)?Sotorasib?KRAS-G12C?NSCLC?Sotorasib?模?研?7?Sotorasib?/Revolution?Medicines?SHP2?RMC-4630?研?11?NSCLC?3?27%?PR?2?研?7?(64%)?10?11?BridgeBio?Pharma?SHP2?BBP-398?Soto

    16、rasib?1/2?模?FDA?(RTK)?Sotorasib?Sotorasib?副?RTK?尼?SHP2?SOS1?CodeBreaK?101?ESMO?副?Sotorasib?EGFR?Vectibix?panitumumab?KRAS?G12C?CLL?Ib?的?研?37?DCR?92.5%?mPFS?5.7?研?(RECIST?1.1)?88%?5.9?8.8?mOS?Sotorasib?Drug Data Report Series:Sotorasib 20 Copyright2022?(?)?溶?KRASG12C?(NSCLC)?确?NSCLC?CLL?确?KRAS?Sotora

    17、sib 溶?KRAS?p.G12C?NSCLC?KRAS?/?NSCLC?KRAS?p.G12C?Sotorasib?CDE?Drug Data Report Series:Sotorasib 21 Copyright2022?(?)?6.?/?尼?WO2018119183WO2018119183?KRASG12C?3,4-b?2,3-d?2,3-d?2018?8?23?尼?尼?US20180177767A1US20180177767A1?2037-12-21?US62438334P0US62438334P0?/?US10532042B2US10532042B2?2037-12-21?US20

    18、200069657A1US20200069657A1?2037-12-21?US11285135B2US11285135B2?2037-12-21?US20220168280A1US20220168280A1?/?研?CN110366550A?/?尼?WO2018217651WO2018217651?Kras?g12c?inhibitors?and?methods?of?using?the?same?KRAS-G12C?2018?11?29?尼?尼?US20180334454A1US20180334454A1?2038-05-21?US62509629P0US62509629P0?/?US10

    19、519146B2US10519146B2?2038-05-21?US20200055845A1US20200055845A1?/?US20210009577A1US20210009577A1?/?研?CN110997668A?1?4?Sotorasib?Sotorasib?Drug Data Report Series:Sotorasib 22 Copyright2022?(?)?尼?WO2020102730A1WO2020102730A1?Improved?synthesis?of?key?intermediate?of?KRAS-G12C?inhibitor?compound?KRAS-G

    20、12C?2020?5?22?尼?尼?US62768802P0US62768802P0?/?US20200216446A1US20200216446A1?2040-02-01?US11299491B2US11299491B2?2040-02-01?US20220220112A1US20220220112A1?/?研?sotorasib?4a?5M?29?9?14?CN113015724A?Drug Data Report Series:Sotorasib 23 Copyright2022?(?)?7.Sotorasib?研?Sotorasib?83.4?666.8?19000?5%副?FIRST

    21、?STEP?0?5?Amgen?Assist?360?研?研?2015?2019?KRAS?G12C?26.3?29.3?2024?33.5?2028?KRAS?40?KRAS-G12C?副?Sotorasib?副?9?6200?38%?1500?2500?Sotorasib?7700?24%?副?1.39?first-in-class?Evaluate?Pharma?2026?Sotorasib?15.1?告?研 OS?Sotorasib?Sotorasib?Sotorasib?模?研?2000?副?尽?副?Drug Data Report Series:Sotorasib 24 Copyr

    22、ight2022?(?)?8.Sotorasib?40?RAS?副?80?去?告?30%?RAS?KRAS?HRAS?NRAS?KRAS?80%?RAS?KRAS?90%?30-40%?15-20%?KRAS-G12C?KRAS千?KRAS?12?KRAS?44?14?34%?2?KRAS?G12C?KRAS-G12C?Drug Data Report Series:Sotorasib 25 Copyright2022?(?)?KRAS?副?KRAS?Sotorasib?研?130?KRAS?G12C?40?溶?Sotorasib?Mirati?Therapeutics?Adagrasib 溶

    23、?副?KRAS?G12C?NSCLC?Sotorasib?FDA?2022?12?14?Sotorasib?Sotorasib?Adagrasib?研?研?Adagrasib?KRAS?G12C?NSCLC?研?112?48?42.9%?Drug Data Report Series:Sotorasib 26 Copyright2022?(?)?DCR?79.5%?6?5.4%?48?导?1.4?8.5?95%?CI?6.2-13.8?6.5?95%?CI?4.7-8.4?研?Sotorasib?告 Adagrasib?CNS?溶?Mirati?Adagrasib?Mirati?6500?2.73?Sotorasib?Mirati?Therapeutics?KRAS?G12C?溶?研?研?副?尽?KRAS?G12C?研?!#$%&https:/ 26/26 Copyright2021?(?)?

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