圣湘生物科技股份有限公司 关于自愿披露控股子公司产品新增适应症获得临床试验批准的公告

Core Viewpoint - The company, Shengxiang Biotechnology Co., Ltd., has received approval from the National Medical Products Administration for a clinical trial application to expand the indications of its product, Human Growth Hormone Injection (brand name: Haizhiyuan), to include idiopathic short stature (ISS) [1][3]. Group 1: Product Information - The product, Human Growth Hormone Injection (Haizhiyuan), is a water injection formulation developed based on Shengxiang Haiji's injectable human growth hormone, which was approved for market on November 7, 2023, for use in children with growth retardation due to endogenous growth hormone deficiency and those with short stature due to Noonan syndrome [2]. Group 2: Clinical Trial Approval - The clinical trial application for the new indication of ISS has been approved, allowing Shengxiang Haiji to initiate Phase III clinical trials to enhance clinical research data and expand application scenarios [1][3]. Group 3: Impact on the Company - The approval for the ISS indication is expected to optimize the company's business structure, improve strategic product line layout, and enhance core competitiveness [3]. - The company acknowledges the high investment, high risk, and high added value associated with biopharmaceutical products, noting that the clinical trial process is complex and subject to various uncertainties [3].