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皮下注射PD-L1在中国申报上市,拟优先审评

2020-09-19 医药魔方 医药魔方

9月17日,思路迪药业恩沃利单抗注射液上市申请拟纳入优先审评,用于既往接受过氟尿嘧啶类、奥沙利铂和伊立替康治疗的微卫星高度不稳定(MSI-H)晚期结直肠癌和既往至少一线标准治疗失败的MSI-H晚期胃癌

9月17日,思路迪药业恩沃利单抗注射液上市申请拟纳入优先审评,用于既往接受过氟尿嘧啶类、奥沙利铂和伊立替康治疗的微卫星高度不稳定(MSI-H)晚期结直肠癌和既往至少一线标准治疗失败的MSI-H晚期胃癌及其他既往至少一线标准治疗失败的DNA错配修复功能缺陷(dMMR)晚期实体瘤。

恩沃利单抗(KN035)是重组人源化PD-L1单域抗体Fc融合蛋白,由康宁杰瑞自主研发,2016年起与思路迪医药共同开发,有望成为全球首个上市的通过皮下注射给药的PD1/PD-L1抗体。KN035在安全性、便利性、依从性等方面和已上市的同类药物相比,具有显着的差异化优势,可切实改善病人生活品质。

3月30日,康宁杰瑞与先声药业、思路迪医药订立合作协议,就KN035肿瘤适应症在中国大陆的商业化达成战略合作。协议规定,康宁杰瑞是KN035的独家生产商,负责KN035的生产供应;思路迪医药负责KN035的临床开发、注册和市场销售;先声药业负责KN035在中国大陆注册上市后的独家商业推广,先声药业将向思路迪医药收取推广服务费(见:先声药业、思路迪、康宁杰瑞达成PD-L1抗体合作协议)。

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    2020-09-21 smartjoy
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