本报讯(记者李婷)近日，国家医疗保障局、人力资源社会保障部联合公布《国家基本医疗保险、工伤保 险和生育保险药品目录(2025年版)》，厦门特宝生物工程股份有限公司(以下简称"特宝生物")自主研发 的国家1类新药益佩生(通用名：怡培生长激素注射液)成功纳入该目录，将于2026年1月1日正式实施， 此举将有效提升药物可及性，降低患者用药负担，惠及更广泛的矮小症患者群体。 在创新研发领域，特宝生物长期聚焦长效蛋白质药物研发，尤其在聚乙二醇修饰技术领域优势显著。经 过近30年技术积累，公司已构建起以"聚乙二醇长效化药物"为核心的创新平台，依托该平台已上市多款 聚乙二醇长效化国家1类新药，成长为国内聚乙二醇长效蛋白质领域的领军企业。研发投入上，2025年 前三季度公司研发投入达3.12亿元，同比增长38.53%，为持续创新提供强劲支撑；同时公司还推动多平 台技术协同创新，已建立聚乙二醇重组蛋白质修饰、蛋白质药物生产、药物筛选及优化三大核心技术平 台，并在核酸药物、腺相关病毒(AAV)基因治疗等领域形成技术积累。 特宝生物表示，未来将持续加大研发创新力度，推出更多高质量、可及性强的创新治疗方案，助力儿童 生长发育领域规范 ...

2025创新药高质量发展大会12月7日在广州召开，会上发布了2025年《国家基本医疗保险、生育保险和 工伤保险药品目录》，特宝生物(688278)自主研发的治疗用生物制品国家1类新药——长效生长激素益 佩生(通用名：怡培生长激素注射液)成功纳入医保目录。该药物适用于治疗3岁及以上儿童生长激素缺 乏症(GHD)所致生长缓慢，此次入围将有助于减轻我国矮小症患儿家庭的治疗负担，在为患儿家庭提供 新的治疗选择基础上，进一步提升了药物可及性。 近年来，儿童生长发育问题日益受到社会关注。生长激素作为调控儿童生长发育的关键激素，其缺乏不 仅影响身高，还可能增加成年后代谢紊乱、心血管疾病等风险。据统计，我国矮小症患者总数约760 万，然而接受规范治疗的比例不足5%，存在显著的认知率低、就诊率低、治疗依从性差等挑战。部分 家长对孩子身高过度焦虑或对生长激素认识存在极端化误区；部分家长在发现孩子身高低于同龄人时急 于采用药物手段介入干预。实际上，在干预前需要经过专业医学评估和检查判断是否属于生长激素缺乏 症，儿童生长发育的认知亟需科学引导和有效解决方案。 公开资料显示，益佩生是特宝生物自主研发的国家1类新药，是全球首个获批上市的 ...

Core Viewpoint - The company is committed to supporting children with growth hormone deficiency through a charitable initiative, addressing both health and economic challenges faced by affected families [1] Group 1: Company Initiatives - The company has developed a national class 1 new drug, Yipeisheng (怡培生长激素注射液), for treating growth hormone deficiency in children aged 3 and above [1] - The company has decided to donate up to 40,000 doses of Yipeisheng and up to 661,600 RMB in cash to the Beijing Hongxin Xiangtong Charity Foundation to support the "Yilu Xiangban" patient assistance project [1] Group 2: Industry Context - Growth hormone deficiency in children can lead to various issues, including reduced height, lower quality of life, and potential behavioral, cognitive, and psychological disorders [1] - The initiative aligns with the "Healthy China 2030" planning outline, aiming to provide continuous and standardized treatment for more children in need [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]

Core Viewpoint - The company Teva Biopharmaceuticals (688278.SH) has received approval from the National Medical Products Administration for a new indication of its product Yipeisheng (generic name: Yipei Growth Hormone Injection) for "Adult Growth Hormone Deficiency (AGHD)" [1] Group 1 - Yipeisheng is a long-acting growth hormone developed by the company, utilizing 40kD Y-type branched polyethylene glycol for single-molecule modification [1] - The product was previously approved for treating growth hormone deficiency in children aged 3 years and older, with market approval expected by May 2025 [1] - The newly approved clinical trial application expands the indication to include treatment for Adult Growth Hormone Deficiency (AGHD) [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for a new indication of its product Yipeisheng (generic name: Yipei Growth Hormone Injection) for "Adult Growth Hormone Deficiency (AGHD)" [1] Group 1: Product Development - Yipeisheng is a long-acting growth hormone developed by the company, utilizing 40kD Y-type branched polyethylene glycol for single-molecule modification [1] - The product is classified as a Class 1 new drug for therapeutic biological products [1] Group 2: Market Approval - The existing indication for Yipeisheng, which is "for the treatment of growth retardation due to growth hormone deficiency in children aged 3 years and older," was approved for market launch in May 2025 [1] - The newly approved clinical trial application expands the indication to include "Adult Growth Hormone Deficiency (AGHD)" [1]