此新药获批上市主要依据于中国完成对3至17岁儿童生长激素缺乏症患者的3期关键性试验。于此项试验 中，于52周时，隆培生长激素的年化身高速率为10.66厘米╱年，而短效(每日注射)人生长激素为9.75厘 米╱年，两组治疗差异为0.91厘米╱年(95% CI：0.37-1.45，P=0.0010)。隆培生长激素组于52周时的身 高标准差评分(SDS)较基线增加了1.01，短效(每日注射)人生长激素组则增加了0.83， p值为0.0015，从 治疗第13周开始，隆培生长激素组的身高SDS改善幅度较短效(每日注射)人生长激素组更为明显，且该 差异具有统计学显著性。试验所公布的结果表明了与已完成的全球3期关键性试验(该试验支持了FDA及 EMA对其治疗 PGHD的上市批准)的一致性，并证明了隆培生长激素与短效(每日注射)人生长激素相比 的优效性以及同等安全性。 隆培生长激素获BLA批准后，集团已启动全面商业化计划，以确保供应并扩大市场覆盖。为确保隆培生 长激素推出市场时的供应，集团已与合作伙伴 Ascendis Pharma订立商业化供应协议。同时，集团透过 打造一支专注及专业的商业化团队以及实施为商业化、医生认知及市 ...

Core Viewpoint - The introduction of the long-acting growth hormone, Pasi Growth Hormone Injection, in Hainan Boao Lecheng International Medical Tourism Pilot Zone provides a new treatment option for children with growth hormone deficiency (GHD), despite the availability of domestic alternatives. This is attributed to its advanced technology, clinical efficacy, and international safety standards [1][8]. Group 1: Technology and Efficacy - The Pasi Growth Hormone Injection utilizes a mature fatty acid derivatization technology, differing significantly from the domestic product that employs PEG technology. This allows for a longer half-life and reduced dosing frequency, requiring only weekly administration instead of daily [3][6]. - Clinical data indicates that children treated with Pasi Growth Hormone can achieve an annual height increase of approximately 11.0 cm, with reported height growth of 3-4 cm within three months of treatment in the Boao Lecheng area [6][8]. Group 2: Safety and Metabolism - The drug demonstrates a high metabolic recovery rate, with over 94% of the administered dose being excreted through urine and feces by day 28, surpassing the European Medicines Agency's standard of 90% [5]. - Safety profiles show that the adverse reactions reported are common childhood illnesses, with no new safety concerns arising from the use of Pasi Growth Hormone, indicating a safety level comparable to traditional short-acting growth hormones [6][8]. Group 3: Market Implications - The introduction of Pasi Growth Hormone in the Boao Lecheng area highlights China's commitment to synchronizing international medical resources and providing better treatment options for domestic patients, thereby enhancing the overall healthcare landscape [1][8].

Group 1 - The core point of the article is that Changchun High-tech (000661) announced that its subsidiary, Gensci Pharmaceutical, has received the acceptance notice from the National Medical Products Administration for the clinical trial application of GenSci134 injection, a biopharmaceutical developed for treating growth hormone deficiency (GHD) [1] - GenSci134 is intended for the treatment of both adult growth hormone deficiency (AGHD) and pediatric growth hormone deficiency (PGHD), as well as non-GHD conditions such as idiopathic short stature (ISS) [1] - The application specifically targets children experiencing growth retardation due to endogenous growth hormone deficiency (PGHD) and idiopathic short stature (ISS) [1]

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]