康寧傑瑞(09966.HK)恩沃利單抗獲准在中國上市
康寧傑瑞製藥-B(09966.HK)公布,KN035(恩沃利單抗)(商標名稱:恩維達)正式獲得國家藥品監督管理局的附條件上市批准。
KN035由公司自主研發、2016年起與思路迪(北京)醫藥共同開發的重組人源化抗程序性死亡配體1單域抗體Fc融合蛋白,適用於不可切除或轉移性微衛星高度不穩定性/錯配修復功能缺陷的成人晚期實體瘤患者的治療。
2020年3月,公司與先聲藥業(02096.HK)及思路迪(北京)醫藥訂立一份合作協議,獲先聲藥業授予KN035於中國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。
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