VICTOZA
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南京健友生化制药股份有限公司关于产品利拉鲁肽注射液获得美国FDA药品注册批件的公告
Shang Hai Zheng Quan Bao· 2025-04-06 18:16
Core Viewpoint - Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. has received FDA approval for its liraglutide injection, which is expected to positively impact the company's operating performance [1][4]. Group 1: Product Information - Product Name: Liraglutide Injection [6] - Dosage Form: Injection [6] - Specification: 18 mg/3 mL (6 mg/mL) [6] - ANDA Number: 218115 [6] - Indication: Assists in blood sugar control for adults and children aged 10 and above with type 2 diabetes [1][2]. Group 2: Market Context - The original drug is held by NOVO NORDISK INC, which was approved by the FDA for marketing in the U.S. on January 25, 2010, under the brand name VICTOZA [3]. - Currently, only one other company, HIKMA PHARMACEUTICALS USA INC, has a similar liraglutide injection approved for sale in the U.S. [3]. Group 3: Financial Implications - The company has invested approximately RMB 57.3731 million in the research and development of liraglutide injection [3]. - The newly approved product is expected to be launched in the U.S. soon, which may have a positive effect on the company's financial performance [4].