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天士力(600535.SH)子公司注射用重组人尿激酶原增加急性缺血性脑卒中新适应症获药品注册证书
智通财经网· 2025-09-22 08:29
Core Viewpoint - Tianjin Tasly Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its innovative drug, recombinant human urokinase (Puyouke), to be used for thrombolytic treatment of acute ischemic stroke, expanding its market potential and product line in the neurology/psychiatry sector [1] Group 1 - The company’s subsidiary, Tasly Biopharmaceuticals, has been granted a drug registration certificate for Puyouke, which now has a new indication for acute ischemic stroke [1] - Puyouke is the only approved recombinant human urokinase product in China and is the first class of innovative biological drug supported by the national "Major New Drug Creation" project during the "11th Five-Year Plan" [1] - The approval of the new indication enhances the company's product offerings and competitiveness in the market by targeting a broader patient population [1]
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。 ...