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石药集团(01093.HK):SYS6036注射液在中国获临床试验批准

Core Viewpoint - The approval of SYS6036 injection by the National Medical Products Administration of China marks a significant advancement for the company in the field of tumor immunotherapy, potentially expanding its product portfolio in oncology treatments [1] Group 1: Product Development - SYS6036 is a humanized monoclonal antibody drug aimed at tumor immunotherapy, approved for clinical trials in China [1] - The drug is classified under Category 3.3 of therapeutic biological products and is expected to be used for treating various cancers, including melanoma, non-small cell lung cancer, esophageal cancer, and head and neck squamous cell carcinoma [1] - The development of SYS6036 adheres to the research guidelines for biosimilars, indicating a strategic alignment with regulatory standards [1] Group 2: Research Findings - Pharmaceutical and non-clinical research results demonstrate that SYS6036 shows high similarity in quality, safety, and efficacy compared to the reference drug, supporting the initiation of subsequent clinical studies [1]