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中國生物製藥(01177.HK):“派安普利”三線治療鼻咽癌註冊性臨牀試驗達到主要終點
格隆匯 10-12 12:12

格隆匯10月12日丨中國生物製藥(01177.HK)宣佈,由集團與康方生物-B(09926.HK)共同開發及商業化的抗PD-1單抗藥物“派安普利”(商品名:安尼可;研發代號:AK105)用於三線治療轉移性鼻咽癌註冊性臨牀試驗,已於2020年9月完成受試者入組,達到了由獨立影像評估的客觀緩解率主要終點,展示了良好的臨牀療效和安全性,並擬於近期向中華人民共和國國家藥品監督管理局進行新藥上市申請前溝通。

早前,派安普利用於治療至少經過二線系統化療復發或難治性經典型霍奇金淋巴瘤的新藥上市申請已獲得國家藥品監督管理局受理。

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