智慧芽：Sotorasib药物报告（2022）（29页）.pdf

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?