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Fc融合蛋白长效化技术
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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].