浙江海正药业股份有限公司 关于全资子公司制剂产品注射用米卡芬净获得美国FDA批准的公告

Group 1 - The company’s subsidiary, Zhejiang Haizheng Pharmaceutical (Hangzhou) Co., Ltd., has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for injectable Micafungin, allowing it to produce and sell the product in the U.S. market [1][2] - The drug Micafungin is indicated for the treatment of candidemia, acute disseminated candidiasis, candidal peritonitis, and abscesses in adults and pediatric patients aged 4 months and older, as well as for the prevention of fungal infections in hematopoietic stem cell transplant patients [1] - The global sales of injectable Micafungin are projected to be approximately $208.33 million in 2024, with U.S. sales estimated at around $67.57 million [1] Group 2 - The company has invested approximately 17.94 million RMB in the development of injectable Micafungin [2]