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上海莱士(002252.SZ):"SR604 注射液"新增适应症获得药物临床试验批准通知书

Core Viewpoint - Shanghai Raist (002252.SZ) has received approval from the National Medical Products Administration (NMPA) for the clinical trial of SR604 injection, aimed at preventing bleeding episodes in patients with von Willebrand disease [1] Group 1: Drug Information - Drug Name: SR604 Injection [1] - Drug Registration Category: Class 1 therapeutic biological product [1] - Indication: Prevention of bleeding episodes in patients with von Willebrand disease [1] - Application: Clinical trial for domestic production of the drug [1] - Applicant: Shanghai Raist Blood Products Co., Ltd. [1] - Approval Conclusion: The clinical trial application for SR604 injection meets the requirements for drug registration and is approved to proceed [1] Group 2: Existing Clinical Trials - Currently conducted clinical trials for indications include: prevention of bleeding episodes in patients with Hemophilia A/B and congenital factor VII deficiency [2]