Core Viewpoint - China National Pharmaceutical Group's subsidiary, Tianfang Pharmaceutical, has received approval for the supplement application of enteric-coated aspirin tablets, which have passed the consistency evaluation for generic drug quality and efficacy [1][3]. Group 1: Drug Approval Information - The drug approved is enteric-coated aspirin tablets, with a specification of 100mg and classified as a chemical drug [1]. - The approval was granted based on the Drug Administration Law of the People's Republic of China and relevant regulations regarding the consistency evaluation of generic drugs [1]. Group 2: Drug Usage and Market Context - Enteric-coated aspirin tablets are primarily used for treating unstable angina, acute myocardial infarction, and preventing recurrent myocardial infarction, among other conditions [2]. - As of the announcement date, the total R&D investment for this drug project is approximately 9.36 million RMB (about 1.3 million USD) [4]. - The domestic annual sales for this drug in public hospitals and primary medical terminals are estimated to be around 2.8 billion RMB (approximately 400 million USD) for 2024, with first-quarter sales for 2025 at about 800 million RMB (approximately 113 million USD) [5]. Group 3: Market Competition - Other companies, including Chenxin Pharmaceutical and Lepu Medical, have also passed or are deemed to have passed the consistency evaluation for this drug, with a total of 20 companies in the domestic market [5]. Group 4: Impact on the Company - The approval of the drug is expected to enhance its market share due to increased support in medical insurance payments and procurement by medical institutions [7].
中国医药健康产业股份有限公司关于子公司获得药品补充申请批准通知书的公告