Core 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]

格隆汇8月21日丨特宝生物(688278.SH)公布，公司于近日收到国家药品监督管理局核准签发的关于公司 产品益佩生（通用名称：怡培生长激素注射液）新增适应症"成人生长激素缺乏症（AGHD）"的《药物 临床试验批准通知书》，益佩生是公司自主研发的一款采用40kD Y型分支聚乙二醇进行单分子修饰的 长效生长激素，是治疗用生物制品1类新药，其"适用于治疗3岁及以上儿童的生长激素缺乏症所致的生 长缓慢"的适应症于2025年5月获批上市，本次临床试验申请新增的适应症为"成人生长激素缺乏症 （AGHD）"。 ...

特宝生物公告，近日收到国家药品监督管理局核准签发的关于公司产品益佩生（通用名称：怡培生长激 素注射液）新增适应症"成人生长激素缺乏症（AGHD）"的《药物临床试验批准通知书》。益佩生是公 司自主研发的一款采用40kD Y型分支聚乙二醇进行单分子修饰的长效生长激素，是治疗用生物制品 1类 新药，其"适用于治疗 3 岁及以上儿童的生长激素缺乏症所致的生长缓慢"的适应症于 2025年 5月获批上 市，本次临床试验申请新增的适应症为"成人生长激素缺乏症（AGHD）"。 ...