华兰生物：HL08新增适应症临床试验获批

Core Viewpoint - The company has received approval from the National Medical Products Administration for a new drug, HL08, which is a recombinant Exendin-4-Fc fusion protein injection aimed at treating type 2 diabetes and obesity [1] Group 1: Drug Approval Details - The approval notification was issued on February 2, 2026, under the notification number 2026LP00310 [1] - HL08 is classified as a Class 1 therapeutic biological product and is categorized as a new drug [1] Group 2: Drug Characteristics - HL08 is a next-generation GLP-1 receptor agonist developed by the company [1] - The active ingredient is a recombinant Exendin-4-Fc fusion protein, which combines Exendin-4 with the Fc fragment of IgG2 antibody [1] - This fusion significantly extends the biological half-life of the drug, enhancing convenience and sustained efficacy in treatment [1] Group 3: Indications - The original approved indication for HL08 was to improve blood glucose control in patients with type 2 diabetes [1] - An additional indication has been approved for improving weight control in obese patients [1]