????

?й??????й?????????????????????????????

?????????II?e???

??II

??

??1991

???????????

????ι?

?????1?????йг??г?ɡ??????????????е1???????????Ч??II?????Ч??I?

??I???,??,?????????????????y????С??????Ч???

????II?????????Ч

CFDA???II9?????20mg?????IIг???????????????ú?????2012áй??2014?й???棬??3?????о????Ч???????Ч?ζ???о?

?????????II??IУ?г???50%????????????????20mg*30?/Уг??21.6??1~2????262.8-525.6?????30mg*7?/Уг??35.8??1???1866.7?

???????Ч????á???????70%?????????????3.3?????????????

?e?

?

??2000

??????????????á

???????

????2014?2010??·??27.48???20.90/10??8.89%λ?6λ

?а?1998?г???Debiopharm?????????20142012??FDA???????????У???Χз????бδге????????

?????????50mg0.1g??100ml0.1g?????50mg0.1g????????????--54.43%2015Q1~Q3??λ???????????з?????30%????????????18%??????

??б???к?????????ó????

????б?265????б?2,515??10????8????????8???6,360???60,360??????????????????4???70%???????e??????????????

??????б???б???б??????????????й????????ò??

?

? ?

????????γ?

(1)????С35???л?7?С6￡?????

(2)???-ST???????Q???????????á

-ST?????????????á

???????

?????е????????з1998У2001SFDA?ò??????з??????2000ùSFDA?ò????

????2??????????2013?????????ν2015???Ч????90%?г?��?????????16%??6.4%

?????????????????????е?á?????У?ò??????г???????

÷???????????????????????????????????????????У?????б?б

?????????????????г??????????????￡????????????е?????????????δ??????￥ 

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