VISEN PHARMA-B(02561) core product Longpei growth hormone approved for domestic market, weekly formulation innovation expected to reshape competitive landscape.

On January 26th, the official website of the National Medical Products Administration (NMPA) showed that VISEN PHARMA-B (02561) core product Longpei growth hormone has been approved for market launch, becoming the third long-acting growth hormone approved for sale domestically, used to treat pediatric growth hormone deficiency (PGHD). Public information shows that Longpei growth hormone is a new long-acting growth hormone introduced by Visen Pharma from Ascendis Pharma. The product has previously been approved in Europe and the United States, demonstrating strong commercial growth since its launch. With the TransCon "temporary link technology" long-acting pathway, Longpei growth hormone is the only long-acting growth hormone that releases unmodified human growth hormone continuously in the body between weekly doses. In terms of safety, Longpei growth hormone is overall safe and well-tolerated, with adverse events consistent in type and frequency with those observed with short-acting human growth hormone therapy, and comparability between test groups. Longpei growth hormone provides a convenient once-weekly dosing regimen, reducing injection frequency by 86% compared to daily regimens. Clinical trials in the global and Chinese market have shown that this product is the only long-acting growth hormone to date that is superior to daily growth hormone products. Currently, the domestic growth hormone market is dominated by daily regimens. The active ingredient in Longpei growth hormone's weekly formulation is structurally identical to human growth hormone secreted by the body, and clinical trial results show superiority over daily regimens, potentially filling a technological gap in this field and providing patients with new treatment options. Based on substantial progress in the innovative pipeline, Visen Pharma is expected to drive the establishment of a commercialization system, significantly enhancing positive expectations for its future growth logic and track prospects.