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research · [1 source] · · 中文(ZH) 复星医药:控股子公司药品新增适应症获欧盟批准
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Fosun Pharma subsidiary gains EU approval for two new cancer drug indications

Fosun Pharma announced that its subsidiary, Shanghai Henlius Biotech, has received European Commission approval for two new indications for its drug, Serplulimab Injection (Hetronifly®). These approvals cover the first-line treatment of advanced esophageal squamous cell carcinoma and non-squamous non-small cell lung cancer in adult patients under specific conditions. This marks a significant expansion of the drug's therapeutic applications within the European market. AI

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RANK_REASON Product approval for a pharmaceutical drug by a major regulatory body. [lever_c_demoted from significant: ic=1 ai=0.0]

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  1. 36氪 (36Kr) TIER_1 中文(ZH) ·

    Fosun Pharma: Subsidiary's Drug Approved by EU for New Indication

    复星医药公告,近日,公司控股子公司上海复宏汉霖生物技术股份有限公司及其控股子公司自主研发的斯鲁利单抗注射液(欧盟商品名:Hetronifly®)的如下两项新增适应症获欧盟委员会批准:1、联合氟尿嘧啶类及铂类化疗,适用于PD-L1综合阳性评分(CPS)≥5、不可切除的局部晚期、复发或转移性食管鳞状细胞癌(ESCC)成人患者的一线治疗;2、联合卡铂与培美曲塞,适用于EGFR基因突变阴性、ALK或ROS1阴性的不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌(nsNSCLC)成人患者的一线治疗。据此,该等新增适应症已于所有欧盟成员国及冰岛、列支敦士登和挪威(分…