九洲药业：西格列汀二甲双胍缓释片ANDA通过美国FDA上市许可批准

Core Viewpoint - Jiuzhou Pharmaceutical (603456.SH) announced that its subsidiary, Zhejiang Jiuzhou Biopharmaceutical Co., Ltd., has received temporary approval from the FDA for its Abbreviated New Drug Application (ANDA) for Sitagliptin Metformin Extended-Release Tablets, which are used for treating type 2 diabetes patients whose blood sugar is not adequately controlled with metformin alone or who are receiving combination therapy [1] Group 1 - The Sitagliptin Metformin Extended-Release Tablets are primarily indicated for type 2 diabetes patients [1] - The original drug, JanumetXR, was developed by Merck and launched in the U.S. in February 2012 [1] - Currently, the original product is the only one available in the U.S. market, as it is still under patent protection [1] Group 2 - The projected sales for the drug in the U.S. market in 2024 are approximately $1.1 billion [1]