北極星藥業 - 股票
By Selena
at 2021-04-27T19:38
at 2021-04-27T19:38
Table of Contents
北極星藥業(6550)表示,收到FDA認可之獨立機構「數據和安全監視委員會(DSMB)」主動對正進行之肺間皮癌三期臨床試驗來文;由於整體存活率(OS)與無惡化生存期(PFS)兩者之CP值均已超過80%,建議提早結束肺間皮癌三期試驗直接申請藥證。
北極星表示,近期將與FDA進行會議,考慮依循DSMB之建議與FDA協商提早結束肺間皮癌三期臨床試驗直接申請藥證。
北極星藥業試驗是以ADI-PEG 20聯合化療藥 Pemetrexed及 Cisplatin 治療末期肺間皮癌的多國多中心二/三期雙盲臨床試驗,預計於美國、英國、澳洲、台灣及義大利等五個國家多中心進行臨床試驗及後續於台灣、美國、歐盟等各地區申請新藥查驗登記審查
https://turnnewsapp.com/livenews/finance/A89453002021042718580329
http://www.genetinfo.com/investment/featured/item/47993.html
北極星特快車一路北上看極光
生技重返榮耀 下一個護國產業
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