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中国医药: 关于子公司获得化学原料药上市申请批准通知书的公告

Core Viewpoint - China National Pharmaceutical Group's subsidiary, Tianfang Pharmaceutical, has received approval for the listing application of the chemical raw material drug, Fumaric Acid Vonoprazan, indicating compliance with domestic drug registration requirements and enhancing the company's integrated development strategy in raw materials and formulations [1][2]. Group 1: Drug Approval Information - The drug approved is Fumaric Acid Vonoprazan, with the acceptance number CYHS2460031 and registration number Y20230001371 [1]. - The drug is packaged in 20kg barrels and produced by Tianfang Pharmaceutical [1]. - The approval was granted based on the review of the drug's compliance with the Drug Administration Law of the People's Republic of China [1]. Group 2: Drug Usage and Market Context - Fumaric Acid Vonoprazan is primarily used for treating gastroesophageal reflux disease and is combined with appropriate antibiotics to eradicate Helicobacter pylori [2]. - As of the announcement date, approximately 11.36 million RMB has been invested in the research and development of the drug's raw materials and formulations [2]. - There are 64 registered numbers for Fumaric Acid Vonoprazan in China, with 28 showing an "A" status according to the National Medical Products Administration [2]. Group 3: Impact on the Company - The approval of Fumaric Acid Vonoprazan will strengthen the company's strategy of integrating raw materials and formulations, expanding its product range [2]. - The company plans to actively promote the production and sales of the drug, although future sales may be affected by national policies and market conditions [2].