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1年长高11厘米!维昇药业生长激素周制剂获批上市
Xin Lang Cai Jing· 2026-01-26 11:09
Core Viewpoint - Lonapegsomatropin, developed by Ascendis Pharma in collaboration with Weisheng Pharma, has been approved for market release in China for the treatment of growth hormone deficiency in children [1][5]. Group 1: Product Approval and Details - The National Medical Products Administration (NMPA) approved the injection of Lonapegsomatropin on January 20, 2026, under multiple registration numbers [3][7]. - Lonapegsomatropin is designed using the innovative TransCon (Transient Conjugation) technology platform, allowing for weekly administration, unlike most existing growth hormone products that require daily injections [3][7]. Group 2: Clinical Research and Efficacy - In 2021, Lonapegsomatropin was approved in the U.S. for children weighing at least 11.5 kg (25.4 lbs) with growth disorders due to endogenous growth hormone deficiency [4][8]. - A Phase III study in 2022 for Chinese children with growth hormone deficiency showed that after 52 weeks of treatment, the annualized height velocity (AHV) for Lonapegsomatropin was 10.66 cm/year compared to 9.75 cm/year for daily growth hormone formulations, demonstrating non-inferiority [4][8].