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          “Fast follow??????“Fast”????β???“Follow”??

??????????????????????????棬??????????????????????????????????????????????????й????棬??????????????????????????????????????·????????????棬??????????????????????????????????????????????????????????
?й?????????????л????????????“???????????з?????????????????????????????????????????????????????????????????????????????????”
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????????????з?????????·??????????????First-in-class????????????????Fast follow???Me-Only????
 
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First-in-class????????з????????????????????????о??????????????????????????????????????????з?????????FDA???壬??????First-in-class?????????????????????????????????????????????????????????????е?????е?????????????????????о?????????????????????????????????????????????????????????first-in-class???????????д???????о???????????First-in-class?????л?????????????——??????г?????????????о???????????????
??????????????????????????“??а?????????”????First-in-class?????в?????First-in-class??????а????е???????????????????????????????????????????
Fast follow????????????????First-in-class?????????????о???????Me-too??Me-better??Me-worse??Me-best??Fast follow??????????????????????????????????ае????????????????н???????????????Σ???????????????????????????????Ч?????????
Fast follow?????????????壨NCE???????????????????????У?Me-too????????????????????С?????????????????Ч??????First-in-class????????Me-better?????????Щ??????????????????????????????????????????????????????Me-worse??????壬??????????????????????Me-best??????????First-in-class?????????????????????????е?????????????????????????????????????
Me-only??????????First-in-class????First-in-class??????????Me-only???????????????Ч???????????????Me-too????????????????????????????????????????????????????????
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??1??First-in-class??????
?????????????????????1999-2018??FDA?????620???????????????first-in-class?????194??????????????
???????????????????????“??”??????????????????з?????10???????????10?????2016????????о?????Tufts Center???????????first-in-class????з????????????26????????????Tufts???о???????з????????????????????????????????????з???????????????????9???????Tufts?????У?9????????????????????????????С?
??????ο???????????????з?????1????????7???????????A???г???????????????2019???з????ó???10???????????????????????к???????38???????????????20??????????????13???????????????12???????????????10?????5????????????????????????????е?First-in-class?????з????????????????????????????裬??????????????????Щ???????????FIC?????м???????????????????????????????????2??12???NMPA??????????к?????δ????
 
?1 2018????????????з???????а?
 
????First-in-class???????????????????????????2018?????????110????????з????????а???????????????з???????108????????????з????λ?????????97.5??????????ò??????????????????????з?????????????????????????????????????з????????????????????н?????
??2??Fast follow???????
??????????????????????????????????з??????????????????????????????Σ????????????????Σ????Fast follow????????????????з?·????????????????????????????????????????????????????????????PD-(L)1??BTK??CD47??????е?????в???????????I???????????????????????????????II???????????????????????????????????????????????ò??????????????????????????С??????????????????????????????з?????飬?????????????????????????????????????????У??????????????????????????????г????????1.4w??????????????????æ²»??“??”???
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??Fast follow????????????????????????????????????
??PD-1?????????????????Ч???????????PD-1?з?????????????Follow???????????????????????????涨??е???????м??????????????Me-too????????з???????????????????????????PD-1???????????????????
?????????????????????????????????????é¡£FDA??????棬PD-1?????з????????????????????K???????????С??????????з??????????????????????ο?K??????????á?????“????”?????????????50????????????????????????????????з???????????????п????????????????????????????é¡£
??????????з????????????????????????????First in class???г???????????????????????Ч??????????Me-too??Me-better????????????????з??????档???????????????????????????????к?follower???????Ч?????????????????????г???λ???????Σ??
????????????òο????????????????????follower????????г??????????????5????follower?г?????????????ò????????????Fast follow??????“Fast”????β???“Follow”??
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(2020/6/30 14:25:22      ???2067??)

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