维昇药业注射用隆培生长激素获批

Core Viewpoint - The approval of the long-acting growth hormone, Rongpei (SKYTROFA), by the National Medical Products Administration marks a significant advancement in the treatment of growth hormone deficiency in children aged 3 and above in China [1]. Group 1: Product Approval - Weisheng Pharmaceutical has received approval for the marketing authorization of Rongpei growth hormone in China [1]. - The product is specifically indicated for treating growth retardation due to growth hormone deficiency in children and adolescents [1]. Group 2: Product Characteristics - Rongpei is a weekly administered growth hormone replacement therapy, distinguishing itself as the only long-acting growth hormone that has demonstrated superior efficacy and equivalent safety compared to short-acting daily injections in positive parallel-controlled trials [1]. - The drug has successfully completed Phase III pivotal trials in China [1].