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李氏大药厂:Socazolimab已获国家药监局批准于中国内地联合化疗用于广泛期小细胞肺癌的一线治疗

Core Viewpoint - The approval of Socazolimab for first-line treatment of extensive-stage small cell lung cancer in mainland China represents a significant advancement for the company and the oncology sector, highlighting the drug's efficacy and safety profile based on clinical trial results [1] Company Summary - Lee's Pharmaceutical (00950) announced that its subsidiary, China Oncology Medical Co., has received approval from the National Medical Products Administration for Socazolimab to be used in combination with chemotherapy for first-line treatment of extensive-stage small cell lung cancer [1] - Socazolimab is a fully human anti-PD-L1 monoclonal antibody that has already been approved for first-line treatment of recurrent or metastatic cervical cancer and extensive-stage small cell lung cancer [1] Industry Summary - The approval is based on a Phase III, multi-center, randomized, double-blind, placebo-controlled clinical trial involving 54 centers, led by Professor Lu Shun from Shanghai Chest Hospital [1] - The trial results indicated that patients receiving Socazolimab had a significantly improved overall survival of 13.90 months compared to 11.58 months in the placebo group, without increasing safety risks associated with the treatment [1] - Another Phase III clinical trial for Socazolimab in the treatment of persistent, recurrent, or metastatic cervical cancer is currently ongoing [1]