速递｜中国首款周制生长激素落地！诺和诺德生长激素获批上市

Core Viewpoint - The article discusses the approval and clinical efficacy of the long-acting growth hormone injection, Pasi Growth Hormone, developed by Novo Nordisk, which is now available in China for treating growth hormone deficiency in children aged 2.5 years and older [4][6]. Group 1: Product Approval and Details - Pasi Growth Hormone injection received approval from the National Medical Products Administration in China on December 22, 2025, with the approval number SJ20250030 [6]. - The product is a long-acting growth hormone analog that has been optimized to extend its half-life, allowing for weekly administration [4][6]. - It was first approved by the FDA in the United States in August 2020 for adult growth hormone deficiency and expanded its indications in April 2023 to include both children and adults [4]. Group 2: Clinical Efficacy - The efficacy of Pasi Growth Hormone has been validated in multiple global Phase III clinical studies, including the REAL4 study, which confirmed its safety and efficacy in an international population [8]. - In the REAL6 study conducted in China, 110 previously untreated children were randomized to receive either Pasi Growth Hormone or a daily regimen of recombinant human growth hormone. The results showed that the average height growth rate in the Pasi group was 11.0 cm/year, comparable to the daily regimen group [8]. - The overall safety profile of Pasi Growth Hormone was consistent with previous growth hormone formulations, with an injection site reaction rate of only 2.7% and no reported injection site pain during the 52-week treatment period, indicating a lower treatment burden and good drug tolerance [8].