先聲藥業(02096.HK)：國家藥監局受理KN035上市許可申請
格隆匯12月21日丨先聲藥業(02096.HK)公告，於2020年12月17日，中國國家藥品監督管理局已受理KN035（一種重組人源化抗程序性死亡配體1（PDL1）單域抗體，用於治療微衞星高度不穩定性（MSI-H）╱錯配修復功能缺陷（dMMR）晚期實體瘤）的生物製品上市許可申請。
KN035是公司與康寧傑瑞製藥-B(09966.HK)、思路迪（北京）醫藥科技有限公司進行合作的產品，由康寧傑瑞自主研發，2016年起與思路迪醫藥共同開發，在中國、美國和日本針對多個腫瘤適應症開展臨牀試驗，結果顯示出可控安全性及前景良好的臨牀效果。KN035預期將於獲批後成為全球首個通過皮下注射給藥的PD-1/PD-L1抗體。
KN035的BLA乃基於KN035於中國的II期臨牀試驗的結果作出。103名MSI-H/dMMR晚期癌症患者於25箇中心參與試驗。整體的客觀緩解率（ORR）為42.7%。結腸直腸癌（CRC）(n=65)、胃癌(n=18)及其他癌症(n=20)的患者的ORR經設盲的獨立評審委員會評估及確認後分別為43.1%、44.4%及40.0%。
據悉，KN035是重組人源化抗PD-L1單域抗體Fc融合蛋白，由康寧傑瑞自主研發，2016年起與思路迪醫藥共同開發。於2020年3月30日，公司全資附屬公司江蘇先聲藥業有限公司、江蘇康寧傑瑞生物製藥有限公司（康寧傑瑞全資附屬公司）及思路迪醫藥訂立一份合作協議。根據先聲協議，江蘇先聲獲授予KN035於中國大陸內的腫瘤適應症的獨家市場推廣權及對外許可或轉讓下的優先受讓權。
KN035在中國、美國和日本針對多個腫瘤適應症開展臨牀試驗，入組受試者總計超過900名。美國食品藥品監督管理局(FDA)於2020年1月18日授予KN035治療晚期膽道癌的孤兒藥資格。TRACON Pharmaceuticals,Inc.（其股份於納斯達克全球精選市場上市（股份代號：TCON））獲授KN035於美國、加拿大、墨西哥及其各自屬地在人類肉瘤治療方法領域上的獨家及不可轉讓許可。
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