亚宝药业集团股份有限公司关于SY-005项目新适应症获得临床试验批准通知书的公告

Core Viewpoint - The announcement highlights that Yabao Pharmaceutical's subsidiary, Suzhou Yabao, has received approval from the National Medical Products Administration for clinical trials of the SY-005 injection for a new indication related to neurological deficits after brain glioma surgery [1][2]. Group 1: Drug Information - Drug Name: SY-005 Injection [1] - Dosage Form: Injection [1] - New Indication: Neurological deficits after brain glioma surgery [1] - Registration Category: Class 1 therapeutic biological product [1] - Applicant: Suzhou Yabao Pharmaceutical Research Co., Ltd. [1] - Acceptance Number: CXSL2500489 [1] - Approval Conclusion: The clinical trial application for SY-005 injection has been approved for the new indication [1][2]. Group 2: Research and Development Status - SY-005 is an innovative recombinant protein that received approval for the indication of sepsis in November 2018 and is currently in Phase II clinical trials [2]. - Brain glioma is the most common primary malignant tumor in the brain, accounting for approximately 80% of primary malignant brain tumors in China, characterized by high disability and recurrence rates [2]. - Post-surgical neurological deficits are common complications affecting patients' quality of life and adherence to subsequent tumor treatments, which may indirectly shorten survival [2]. Group 3: Financial Investment - As of the date of the announcement, the company has invested approximately 126.88 million RMB in the SY-005 project [3].