九洲药业：控股子公司九洲生物获得西格列汀二甲双胍缓释片ANDA批准文号

Core Viewpoint - Jiuzhou Pharmaceutical's subsidiary, Jiuzhou Biotech, has received temporary approval from the FDA for the ANDA of Sitagliptin Metformin Extended-Release Tablets, which is primarily used for blood sugar control in type 2 diabetes patients [1] Group 1 - The drug is a generic version of Janumet XR, originally developed by Merck [1] - The total R&D investment by Jiuzhou Pharmaceutical in this drug amounts to approximately 14.73 million yuan [1] - The approval of the ANDA will enhance the company's market competitiveness, although the product must wait for patent expiration and final FDA approval to be eligible for sale in the U.S. market [1]