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维昇药业-B(02561):注射用隆培生长激素的生物制品上市许可申请获国家药监局批准
智通财经网· 2026-01-26 10:49
Core Viewpoint - The approval of the long-acting growth hormone, Lonapegsomatropin (SKYTROFA®), by the National Medical Products Administration of China marks a significant advancement in the treatment of pediatric growth hormone deficiency (PGHD) in children aged 3 and above, providing a more convenient weekly dosing option compared to daily injections [1][2]. Group 1: Product Approval and Efficacy - Lonapegsomatropin is the first long-acting growth hormone that has demonstrated superior efficacy and equivalent safety compared to short-acting daily injections in a positive parallel-controlled trial [2][3]. - In a pivotal Phase 3 trial involving children aged 3 to 17 with PGHD, Lonapegsomatropin showed an annualized height velocity of 10.66 cm/year, compared to 9.75 cm/year for short-acting growth hormone, with a statistically significant difference of 0.91 cm/year (P=0.0010) [3]. - The height standard deviation score (SDS) for the Lonapegsomatropin group increased by 1.01, while the short-acting group saw an increase of 0.83, with a p-value of 0.0015, indicating significant improvement from week 13 onwards [3]. Group 2: Commercialization Strategy - Following the BLA approval, the company has initiated a comprehensive commercialization plan to ensure supply and expand market coverage for Lonapegsomatropin [4]. - The company has established a commercialization supply agreement with Ascendis Pharma to secure market launch supplies [4]. - Strategic partnerships have been formed with Shanghai Pharmaceuticals, United Family Healthcare, and Anke Bioengineering to enhance distribution and promotional activities for Lonapegsomatropin [4].