智通财经APP讯，九洲药业(603456.SH)发布公告，近日，公司控股子公司浙江九洲生物医药有限公司 (简称"九洲生物")向美国食品药品监督管理局(简称"FDA")提交的西格列汀二甲双胍缓释片简略新药申 请的(简称"ANDA")已获得美国FDA的暂时批准(暂时批准：指FDA已经完成仿制药的所有审评要求，但 由于专利权或专卖权未到期而给予的一种批准形式)。 西格列汀二甲双胍缓释片主要用于经二甲双胍单药治疗血糖仍控制不佳或正在接受二者联合治疗的2型 糖尿病患者。西格列汀二甲双胍缓释片的原研药为JanumetXR，由默沙东公司研发，于2012年2月在美 国上市。目前该药品在美国尚处于专利保护期内，美国市场上仅有原研产品上市销售。根据公开数据显 示，2024年该药品美国市场销售额约11亿美元。 ...

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]