AMOYTOP(SH:688278) Zheng Quan Zhi Xing·2025-08-21 16:58Core Viewpoint - Xiamen Te Bao Biological Engineering Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of its product Yipeisheng (generic name: Yipei Growth Hormone Injection) for a new indication of Adult Growth Hormone Deficiency (AGHD) [1][2] Group 1: Drug Information - The product Yipeisheng is a long-acting growth hormone developed by the company, utilizing a 40kD Y-shaped branched polyethylene glycol for single-molecule modification [1] - Yipeisheng was previously approved for treating growth hormone deficiency in children aged 3 and above, with the approval granted in May 2025 [1] Group 2: Clinical Significance - Adult Growth Hormone Deficiency is caused by hypothalamic-pituitary dysfunction, leading to insufficient synthesis or secretion of growth hormone, resulting in growth and metabolic disorders [2] - Clinical features of AGHD include abnormal body composition and function, often accompanied by multiple complications that impair physical and mental health and affect quality of life [2] - Yipeisheng has the potential to provide effects equivalent to endogenous growth hormone for treating AGHD [2] Group 3: Company Impact - The approval for clinical trials does not have a significant immediate impact on the company's operating performance [2] - The drug development process is characterized by long cycles, high investment, and substantial risks, with many uncertainties regarding subsequent research progress and approval outcomes [2]