Core Viewpoint - Shanghai Haixin Group's subsidiary, Jiangxi Gannan Haixin Pharmaceutical Co., Ltd., has received approval for its Vitamin B6 injection to pass the consistency evaluation of quality and efficacy for generic drugs, enhancing its market competitiveness and experience for future drug development [1][6]. Group 1: Drug Information - The drug is named Vitamin B6 Injection, in the form of an injection with a specification of 1ml:0.1g, classified as a chemical drug [1]. - The approval number for the drug is H20258295, and it has been granted a 12-month validity period [1]. - The drug is indicated for the prevention and treatment of Vitamin B6 deficiency, as well as for various conditions such as pregnancy-related issues and certain metabolic disorders [2][3][4]. Group 2: Market Situation - Vitamin B6 is a water-soluble vitamin that cannot be synthesized by the human body and must be obtained through diet or intravenous injection [7]. - The injection is classified as a Category A drug under national medical insurance and is included in the national essential drug list, indicating its widespread application in disease prevention and treatment [7]. - According to the Minet database, the sales revenue of Vitamin B6 injection in public medical institutions in China is projected to be approximately RMB 304 million in 2024 [7]. Group 3: Impact on the Company - The approval of Vitamin B6 injection enhances the market competitiveness of Jiangxi Gannan Haixin and contributes to the accumulation of experience for future drug development [6]. - The current operational performance of the company is not expected to be significantly impacted by this approval [6].
上海海欣集团股份有限公司关于子公司药品通过仿制药一致性评价的公告