Group 1 - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security have announced the inclusion of the new drug Yipeisheng (generic name: Yipei Growth Hormone Injection) developed by TeBao Bioengineering Co., Ltd. in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025 Edition), effective from January 1, 2026, which will enhance drug accessibility and reduce the medication burden for a wider range of patients with dwarfism [1][2] - The prevalence of dwarfism among children in China is approximately 3%, corresponding to about 7.6 million patients, but the standardized treatment rate is less than 5%, with traditional treatment options being a significant limiting factor [1] - Yipeisheng is the world's first Y-type 40kD polyethylene glycol long-acting growth hormone, primarily used for treating growth retardation due to growth hormone deficiency in children aged 3 and above, featuring a structural modification that preserves biological activity and allows for weekly administration [1] Group 2 - TeBao Bio has focused on the research and development of long-acting protein drugs, particularly excelling in polyethylene glycol modification technology, establishing itself as a leading enterprise in the domestic long-acting protein field after nearly 30 years of technological accumulation [2] - In the first three quarters of 2025, the company's R&D investment reached 312 million yuan, a year-on-year increase of 38.53%, providing strong support for continuous innovation [2] - The company aims to continue increasing R&D efforts to launch more high-quality and accessible innovative treatment solutions, contributing to the standardized diagnosis and treatment of dwarfism and benefiting more children and families, aligning with the "Healthy China 2030" strategy [2]

Core Insights - The 2025 Innovation Drug High-Quality Development Conference will be held on December 7 in Guangzhou, where the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Directory will be released, including the long-acting growth hormone Yipeisheng developed by TEBIO [1] Group 1: Product Development and Market Impact - Yipeisheng is the first globally approved Y-type 40kD polyethylene glycol long-acting growth hormone, reducing the injection frequency from daily to weekly, significantly alleviating the psychological burden on children [2] - The product is preservative-free and features a "single-use" design, greatly reducing the risk of microbial contamination and cross-infection [2] - The accompanying smart electronic injection pen "Yushida" addresses children's fear of injections with an innovative needle-hidden design, allowing for self-administration by older children and enhancing treatment adherence [2] Group 2: Social Responsibility and Public Health - TEBIO is actively engaged in social responsibility through donations to the "Little Bamboo Shoot" children's health care project, focusing on early screening, diagnosis, and standardized treatment of growth disorders [3] - The inclusion of Yipeisheng in the national medical insurance directory is expected to significantly improve accessibility to this innovative drug, reducing the economic burden on families and promoting sustainable treatment options for children's growth disorders [3]

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]