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复星医药:斯鲁利单抗注射液的新适应症上市许可获批准

Fosun Pharma: The new indication approval for Surulitinib injection has been granted.

Breakings ·  Dec 3 17:00

Fosun Pharma announced that its subsidiary henlius has independently developed Hanshuo (Surulitinib injection) in combination with Pemetrexed and Carboplatin, suitable for the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with negative epidermal growth factor receptor (EGFR) gene mutation and anaplastic lymphoma kinase (ALK) negativity under the new indication approval application. This application has recently been approved by the National Medical Products Administration. Hanshuo is an innovative anti-PD-1 monoclonal antibody independently developed by Fosun Pharma Group. In addition to the newly approved indications, the pharmaceutical has already been approved in China for related indications, including first-line chemotherapy in combination for squamous non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), among others. Furthermore, the application for marketing authorization in the European Union was accepted by the European Medicines Agency in March 2023, and received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2024.

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