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复宏汉霖(02696):帕博利珠单抗生物类似药HLX17(重组抗PD-1人源化单克隆抗体注射液)在多种已切除实体瘤患者中的临床试验申请获美国食品药品管理局批准

Group 1 - The company, Junshi Biosciences, has received FDA approval for its IND application for HLX17, a biosimilar to Pembrolizumab, intended for use in various resected solid tumor patients [1] - HLX17 is designed to target multiple indications, including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, cholangiocarcinoma, triple-negative breast cancer, and gastric cancer, among others [1] - The clinical trial application for HLX17 was also approved by the National Medical Products Administration (NMPA) in September 2024 [1] Group 2 - According to IQVIA MIDAS data, the global sales of Pembrolizumab are projected to be approximately $32.056 billion in 2024 [2]