注射用达巴万星
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南京健友生化制药股份有限公司 关于子公司产品注射用达巴万星获得美国FDA批准的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-11-28 00:33
Core Points - The company, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd., announced that its subsidiary, Jianjin Pharmaceutical Co., Ltd., received ANDA approval from the U.S. FDA for injectable Dapavans, 500 mg/bottle [1][2] - The approved drug is indicated for the treatment of acute bacterial skin and skin structure infections in adult and pediatric patients [2] - The reference product for the approved generic is held by AbbVie Inc., which was approved by the U.S. FDA on May 23, 2014, under the brand name DALVANCE [2] - Currently, two other companies, Teva Pharmaceuticals Inc. and Fresenius Kabi USA LLC, have also received approval for their generic versions of injectable Dapavans in the U.S. [2] - The company has invested approximately RMB 18.53 million in the research and development of the injectable Dapavans project [3] - The newly approved product is expected to be launched in the U.S. soon, which is anticipated to have a positive impact on the company's operating performance [4]
南京健友生化制药股份有限公司关于子公司产品注射用达巴万星获得美国FDA批准的公告
Shang Hai Zheng Quan Bao· 2025-11-27 19:35
Core Viewpoint - The company, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd., announced that its subsidiary, Jianjin Pharmaceutical Co., Ltd., received FDA approval for its injectable drug Dapavansin, which is expected to positively impact the company's financial performance [1][3]. Group 1: Product Information - The drug name is Dapavansin for injection, with a dosage of 500 mg per bottle [2][6]. - It is indicated for the treatment of acute bacterial skin and skin structure infections in both adult and pediatric patients [1][6]. - The reference product for Dapavansin is held by AbbVie Inc., which was approved by the FDA on May 23, 2014, under the brand name DALVANCE [2]. Group 2: Financial and Development Impact - The company has invested approximately RMB 18.53 million in the research and development of Dapavansin to date [3]. - The newly approved product is expected to be launched in the U.S. market soon, which may have a positive effect on the company's operating performance [3].
28日投资提示:金23转债不下修
集思录· 2025-11-27 14:47
Group 1 - The core viewpoint of the article highlights the approval of a product by a subsidiary of Jianyou Co., Ltd. from the FDA, which is a significant milestone for the company [1][2]. - The article mentions that the Jin 23 convertible bond will not undergo any adjustments, indicating stability in its terms [2]. - The article provides a detailed table of various convertible bonds, including their current prices, redemption prices, last trading dates, and conversion values, which are essential for investors to assess their investment options [4][6]. Group 2 - Jianyou Co., Ltd.'s subsidiary has received FDA approval for its injectable product, Daba Wanxing, which could enhance the company's market position and growth potential [1]. - The article lists several convertible bonds with their respective financial metrics, such as the current price of 110.499 for Hengbang Convertible Bond and a conversion value of 110.63, which reflects the bond's performance [4]. - The convertible bond market is highlighted with various bonds showing different metrics, such as the Z Qibin Convertible Bond with a current price of 109.529 and a conversion value of 109.95, indicating the diverse investment opportunities available [4][6].
健友股份子公司产品注射用达巴万星获得美国FDA批准
Zhi Tong Cai Jing· 2025-11-27 08:36
Core Viewpoint - The company announced that its subsidiary, Jianjin Pharmaceutical Co., Ltd., received ANDA approval from the U.S. FDA for its injectable Dapavansine, 500mg/vial, for treating acute bacterial skin and skin structure infections in adults and pediatric patients [1] Group 1 - The ANDA number for the approved product is 218929 [1] - The approval expands the company's product offerings in the U.S. market [1] - The indication covers both adult and pediatric patients, indicating a broad potential market [1]
健友股份:注射用达巴万星获美国FDA批准
Zheng Quan Shi Bao Wang· 2025-11-27 08:23
Core Viewpoint - The company Jianyou Co., Ltd. has received ANDA approval from the U.S. FDA for its injectable drug Dapavansheng, which is indicated for acute bacterial skin and skin structure infections in both adult and pediatric patients [1] Group 1 - The approved product is a 500mg per bottle formulation [1] - The product is expected to be launched in the U.S. market soon [1] - The approval is anticipated to have a positive impact on the company's operating performance [1]
健友股份:子公司产品注射用达巴万星获得美国FDA批准
Xin Lang Cai Jing· 2025-11-27 08:22
Core Viewpoint - The company announced that its subsidiary, Jianjin Pharmaceutical Co., Ltd., received ANDA approval from the FDA for injectable Dalbavancin, which is expected to positively impact the company's financial performance [1] Group 1: Regulatory Approval - Jianjin Pharmaceutical received ANDA approval for injectable Dalbavancin, 500 mg/vial, on November 27, 2025 [1] - The reference formulation for injectable Dalbavancin is held by AbbVie Inc., which was approved by the FDA on May 23, 2014, under the brand name DALVANCE [1] Group 2: Market Competition - Currently, there are two other companies, Teva Pharmaceuticals Inc. and Fresenius Kabi USA LLC, that have also received approval for injectable Dalbavancin generics in the U.S. [1] Group 3: Investment and Financial Impact - The company has invested approximately RMB 18.53 million in research and development for this project [1] - The newly approved product is expected to be launched in the U.S. soon, which is anticipated to have a positive effect on the company's operating performance [1]