九洲药业(603456.SH)：控股子公司获得美国ANDA批准文号

Core Viewpoint - The company has received temporary approval from the FDA for its abbreviated new drug application (ANDA) for Sitagliptin Metformin Extended-Release Tablets, indicating progress in its product development and potential market entry in the U.S. [1] Company Summary - The company's subsidiary, Zhejiang Jiuzhou Biopharmaceutical Co., Ltd., submitted the ANDA for Sitagliptin Metformin Extended-Release Tablets to the FDA [1] - The drug is primarily used for treating type 2 diabetes patients who have inadequate blood sugar control with Metformin alone or are receiving combination therapy [1] - The original drug, Janumet XR, was developed by Merck and launched in the U.S. in February 2012, and it is currently under patent protection [1] Market Potential - The U.S. market sales for Sitagliptin Metformin Extended-Release Tablets are projected to be approximately $1.1 billion in 2024 [1] - The company has invested around RMB 14.73 million in the research and development of this product to date [1] Competitive Position - The FDA's approval signifies that the company's product has met safety and efficacy standards comparable to the original drug, enhancing its market competitiveness [1] - The product will only be eligible for sale in the U.S. market after the patent expires and the FDA grants final approval [1]