????:1?????VX:??????????

2????yp??

3????????

4?????

5???????

????????????11?10??????????????(? ???????????)??????????????????????113????????????????;????????????????????????14.1????????????;??:????;????????FDA????;????;?KRAS G12C??????????;??????????????????????????;????……????????????11??????????????????????4??????????-11??????????????????????10????????????,????

????????

??????????

11????5?,?,?,?“??????????”?????????“?”?????????????????,???????????????????????,???????????????????,??????????????????????

???????????:????113??????????

11?7?????????????????????????????????,???,????????40?????????????????,??“????”??????????????????30???????????????????????????,??????????,113??????????«?(ICD-11)»??????????,?????????????,?,????????ISO/TC249,????????113?????

????????????????????????

?14.1??

11???7????,????App?,????????,??????????,?????????????2.1????14.1?,????????????????????????571%?????????????2022????????????????4???,??????????,???????????(??????????????)?,?(600436)???????????????

??????????????????:????

11?8??,????????,??????????????????????????????????HRS-2189????????HRS-5041 ???????HRS-1358??HRS-8080????????????????????SHR-8068??????????HRS-620 ????«???????»,?????????

?????????FDA?????????????

11??8?,?????????????????,??????(FDA)???(New Drug Application,NDA),???????????,????????? FDA ?,??????????(EGFR)20 ???(Exon20ins)??(NSCLC)??????????????? FDA ???

????

????????????????

11????6????????,????????,????????®(?)?,?????????????????????(ANCA)??????????????(???[GPA]????[MPA])?????

??????KRAS G12C????????????

11?9???????????????,???,??KRAS G12C?????(???“?????????”)??????????,?KRAS G12C?????(NSCLC)????????????????????????,??????????????????????????????????????????,??1???????????????,????????5????????????,??????6?????????????????????????????????KRAS G12C????,?????????????KRAS G12C??????????????

????????????????????

????????????????????????

11??7???????????????????????????,?????«????»?«???????»??????????????,???,??????????????????????????????????,????«??????????????»«?????????»?????????????????????????????????????????,???????????????????,???????,????????????,?????????????????????????????????????????????,????????????

?

??????????????11?5???

???Aradhana Sarin???????????????????,???????????,????,?????????????????????????

??????????????????,???????????????,?????????????????????????????????????,??(??????) ????????????????????????????:?????