UNITED LAB (03933.HK): Semaglutide Weight Management Application Accepted
NewTimeSpace News: The United Laboratories International Holdings Limited (stock code: 03933) announced that the marketing registration application for the weight management indication of Semaglutide Injection, submitted by its wholly-owned subsidiary Zhuhai United Bio-Pharmaceutical Co., Ltd., has been accepted by the China National Medical Products Administration, with acceptance numbers CXSS2600179, CXSS2600180, CXSS2600181, CXSS2600182 and CXSS2600183.
Semaglutide Injection is a long-acting recombinant human glucagon-like peptide-1 (GLP-1) analogue administered by subcutaneous injection once a week. It is primarily indicated for glycemic control in patients with type 2 diabetes, long-term weight management in patients with obesity or overweight, reduction of major adverse cardiovascular event (MACE) risk in such patients, and treatment of MASH (metabolic dysfunction-associated steatohepatitis) with moderate-to-advanced liver fibrosis. The Company said the product achieves weight loss through mechanisms including appetite suppression, delayed gastric emptying, regulation of energy metabolism and improvement of liver histology.
In January 2025, the Company submitted a marketing registration application for the diabetes indication of Semaglutide Injection, which has been accepted for review. The Company said the new filing broadens the product's indication portfolio, and that it has built a differentiated GLP-1 pipeline combining innovative drugs and biosimilars.
- UNITED LAB (03933.HK): semaglutide weight-management filing accepted
- United Lab(3933.HK) gets US$9M second milestone from Novo for UBT251
- UNITED LAB (03933.HK): NMPA Accepts Filing for IDegLira; First Chinese Biosimilar Applicant
- UNITED LAB (03933.HK): UBT251 injection completes first participant dosing in Phase III clinical study for type 2 diabetes in China
- UNITED LAB (03933.HK): Receives US$13.5 Million Milestone Payment from Novo Nordisk for UBT251