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 supplemental application to produce a new specification (0.1g) of the injectable drug Cytarabine, expanding its product line and enhancing market competitiveness [1][4]. Group 1: Drug Information - The drug approved is Cytarabine for injection, with a new specification of 0.1g, which is a chemical drug registered under the approval number H20269025 [1]. - Cytarabine is used for the induction and maintenance treatment of acute non-lymphocytic leukemia in adults and children, and it is effective against other types of leukemia as well [2]. - The company had previously obtained a registration certificate for the 0.5g specification of Cytarabine in March 2025, with a projected domestic market sales amount of approximately RMB 306 million for 2025 [2]. Group 2: R&D Investment - The company has invested approximately RMB 8.17 million in the research and development of the Cytarabine project to date [3]. Group 3: Impact on the Company - The approval of the 0.1g specification is considered equivalent to passing a consistency evaluation, which will enrich the company's product line and improve its market competitiveness [4].