浙江华海药业股份有限公司 关于获得药品补充申请批准通知书的公告

Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for a supplementary application to produce a new specification (0.1g) of injectable cytarabine, expanding its product line and enhancing market competitiveness [1][4]. Group 1: Drug Information - The drug name is injectable cytarabine, with a new specification of 0.1g approved for domestic production [1]. - The drug is classified as a chemical drug and is used for the induction and maintenance treatment of acute non-lymphocytic leukemia in adults and children, with efficacy against other types of leukemia as well [2]. - The injectable cytarabine was first developed by Upjohn and launched in the U.S. in June 1969, with domestic approval in September 1988 [2]. Group 2: Financial and Market Impact - The company has invested approximately RMB 8.17 million in the research and development of injectable cytarabine [3]. - The domestic market sales for injectable cytarabine are projected to reach approximately RMB 306 million by 2025 [2]. Group 3: Company Impact - The approval of the 0.1g specification is considered equivalent to passing a consistency evaluation, which will further enrich the company's product line and enhance its market competitiveness [4].