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复星医药(600196.SH):枸橼酸伏维西利胶囊新增适应症药品注册申请获批
智通财经网· 2025-09-15 08:52
智通财经APP讯,复星医药(600196.SH)发布公告,近日,公司控股子公司锦州奥鸿药业有限责任公司 就枸橼酸伏维西利胶囊(商品名:复妥宁,项目代号:FCN-437c;以下简称"该药品")新增适应症的药品 注册申请获国家药品监督管理局批准。本次获批适应症为用于激素受体(HR)阳性、人表皮生长因子受 体2(HER2)阴性局部晚期或转移性乳腺癌成人患者:与芳香化酶抑制剂联合使用作为初始内分泌治疗。 该药品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,于2018年被列入国家"重大新药创制"科技重大专项。 ...
复星医药:控股子公司获枸橼酸伏维西利胶囊药品注册批准
news flash· 2025-05-29 09:06
Group 1 - The core point of the article is that Fosun Pharma's subsidiary, Jinzhou Aohong Pharmaceutical, has received approval from the National Medical Products Administration for the registration of a new drug, Citrate Vofopitant Capsules, for specific breast cancer treatment [1] - The approved indication is for the use of the drug in combination with Fulvestrant for adult patients with hormone receptor-positive and HER2-negative recurrent or metastatic breast cancer who have previously undergone endocrine therapy [1] - The new drug is a novel small molecule CDK4/6 inhibitor, and the total R&D investment for this drug is approximately RMB 601 million, expected to be completed by April 2025 [1]