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长春高新:长效生长激素持续领跑全球 10年15万例临床验证安全壁垒
Zheng Quan Shi Bao· 2025-08-06 14:49
Core Insights - Multiple long-acting growth hormones are nearing market approval, breaking the trend of only one product being launched in the past decade, which enhances the diversity of growth hormone options [1] - The safety, efficacy, and quality of new drugs, along with sufficient clinical feedback, are critical for competition in the market [1] Group 1: Product Development and Innovation - Long-term growth hormone technology involves modifying or protecting the hormone to extend its retention time in the body, addressing issues of short-acting formulations [2] - The core subsidiary of Changchun High-tech, Jinsai Pharmaceutical, has focused on developing domestic long-acting formulations after successfully launching short-acting growth hormones [2] - Jinsai Pharmaceutical has optimized the PEG modification process, achieving a half-life extension to 32 hours, allowing for weekly dosing and improved efficacy over short-acting formulations [2][3] Group 2: Quality and Safety Assurance - Ensuring efficacy and safety is paramount for long-acting growth hormones, with individual differences in pediatric patients necessitating long-term monitoring [4] - Jinsai Pharmaceutical has achieved a PEG purity of 100%, significantly higher than the typical 95% standard from suppliers, ensuring product quality and safety [6] - The company has invested heavily in developing a comprehensive production process to maintain high purity levels, overcoming challenges in production quality control [5][6] Group 3: Market Position and Future Strategy - Jinsai Pharmaceutical's long-acting growth hormone, Jinsai Zeng, is currently the only product approved for multiple indications, including GHD, ISS, and TS, setting it apart from competitors [7] - The company aims to expand its international presence and enhance patient care in the pediatric health sector, focusing on continuous improvement in drug formulation [7][8] - The establishment of a positive feedback loop between clinical breakthroughs and patient confidence is essential for driving further innovation in the growth hormone sector [8]
科兴制药内分泌领域创新药GB08长效生长激素研发新进展
Core Viewpoint - Recently, Sinovac Biotech (688136) announced the Phase I clinical trial results of its self-developed innovative drug GB08, a long-acting growth hormone (LAGH), demonstrating good safety and tolerability, comparable pharmacodynamics to existing growth hormones in China, and providing scientific evidence for pediatric dosing selection in future studies [1][4]. Group 1: Drug Development and Technology - GB08 is primarily designed to treat Growth Hormone Deficiency (GHD) in children, characterized by short stature and metabolic complications due to insufficient growth hormone production [2]. - The drug utilizes Fc fusion protein technology, which significantly reduces immunogenicity risks and enhances treatment safety, particularly important for pediatric applications [3]. - GB08 has a long half-life (81.7-110.0 hours) and maintains high levels of IGF-1, aligning with its design goals to extend circulation time in the body and ensure safety without chemical modifications [4]. Group 2: Market Potential and Competitive Landscape - The market for growth hormone therapies in China is expected to grow at a compound annual growth rate (CAGR) of 15.7%, reaching $4.8 billion by 2030, with the 2022 sales of recombinant human growth hormone (rhGH) in public medical institutions estimated at approximately 6.7 billion yuan [5]. - Sinovac Biotech is expanding its endocrine product pipeline, having introduced several products based on overseas market demand, enhancing its competitive positioning in the endocrine field [5]. - The global growth hormone market is projected to reach $7.3 billion by 2032, with a CAGR of about 8.1% from a 2022 market size of $3.4 billion [5].