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康寧傑瑞製藥-B(09966.HK):KN035(恩沃利單抗)獲得國家藥監局在中國的上市批准
格隆匯 11-25 22:40

格隆匯11月25日丨康寧傑瑞製藥-B(09966.HK)公吿,於2021年11月25日,KN035(恩沃利單抗)(商標名稱:恩維達®,一種由公司自主研發,與思路迪(北京)醫藥科技有限公司共同開發的重組人源化抗程序性死亡配體1("PD-L1")單域抗體Fc融合蛋白)正式獲得國家藥品監督管理局附條件上市批准,適用於不可切除或轉移性微衞星高度不穩定性(MSI-H)╱錯配修復功能缺陷("dMMR")的成人晚期實體瘤患者的治療,包括既往經過氟尿嘧啶類、奧沙利鉑和伊利替康治療後出現疾病進展的晚期結直腸癌患者以及既往治療後出現疾病進展且無滿意替代治療方案的其他晚期實體瘤患者。

KN035(恩沃利單抗)是全球首個通過皮下注射給藥的程序性死亡蛋白("1PD-1")╱PD-L1抗體,其獨特的注射方式區別於目前已上市的其他PD-1/PD-L1產品,具有給藥時間短、安全性良好等差異化優勢。KN035(恩沃利單抗)的上市將為中國患者提供高品質且更便捷的PD-L1抗體。

於2020年3月30日,集團與江蘇先聲藥業有限公司及思路迪(北京)醫藥訂立一份合作協議,據此,江蘇先聲獲授予於中華人民共和國(除香港特別行政區、澳門特別行政區及台灣地區外)內進行KN035(恩沃利單抗)的腫瘤適應症的獨家市場推廣權及於中國大陸內對外許可或轉讓下的優先受讓權,惟須受限於合作協議的條款及條件。 

KN035(恩沃利單抗)是重組人源化抗PD-L1單域抗體Fc融合蛋白,由公司自主研發,2016年起與思路迪(北京)醫藥共同開發。於2020年3月30日,公司全資附屬公司江蘇康寧傑瑞生物製藥有限公司、江蘇先聲(為先聲藥業集團有限公司的附屬公司,其股份於香港聯合交易所有限公司上市(股份代號:2096))及思路迪(北京)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,入組受試者總計近1000名。

美國食品藥品監督管理局於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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