复星医药(02196)：FCN-437c胶囊的药品注册申请获国家药品监督管理局受理
复星医药(02196)发布公告，公司控股子公司锦州奥鸿药业有限责任公司(奥鸿药业)就FCN-437c胶囊(以下简称“该新药”)联合氟维司群用于治疗既往接受内分泌治疗后出现疾病进展的激素受体(HR)阳性、人表皮生长因子受体(HER2)阴性的局部晚期或转移性乳腺癌的药品注册申请于近日获国家药品监督管理局受理。
该新药为集团拥有自主知识产权的创新型小分子CDK4/6抑制剂，是一种口服、强效、高选择性、全新结构的创新小分子药物，拟用于晚期/转移性实体瘤(包括 HR+、HER2-的晚期乳腺癌)治疗。该新药已于2018年被列入国家“重大新药创制”科技重大专项。截至2023年10月，集团现阶段针对该新药累计研发投入约为人民币5.14亿元(未经审计)。
截至本公告日，于全球范围内已上市的CDK4/6抑制剂主要包括Pfizer Inc.的哌柏西利胶囊、Eli Lilly and Company的阿贝西利片以及Novartis AG的琥珀酸瑞波西利片等。根据IQVIA MIDASTM最新数据2022年，CDK4/6抑制剂于全球范围内的销售额约为102.26亿美元。
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