HISUN(SH:600267) Ge Long Hui A P P·2026-01-23 09:15Core Viewpoint - Haizheng Pharmaceutical's subsidiary has received FDA approval for the abbreviated new drug application (ANDA) for injectable micafungin, allowing the company to produce and sell the product in the U.S. market [1] Group 1: FDA Approval - Haizheng Pharmaceutical (600267.SH) announced that its wholly-owned subsidiary, Haizheng Pharmaceutical (Hangzhou) Co., Ltd., has received notification from the U.S. FDA regarding the approval of its ANDA for injectable micafungin [1] - The approval signifies that Haizheng Hangzhou can now manufacture and market the product in the United States [1] Group 2: Indications for Use - Injectable micafungin is indicated for the treatment of: 1. Candidemia, acute disseminated candidiasis, candidal peritonitis, and abscesses in adults and pediatric patients aged 4 months and older 2. Candidemia, acute disseminated candidiasis, candidal peritonitis, and abscesses in pediatric patients under 4 months (without meningitis and/or ocular dissemination) 3. Esophageal candidiasis in adults and pediatric patients aged 4 months and older 4. Prevention of candidal infections in adults and pediatric patients aged 4 months and older following hematopoietic stem cell transplantation [1]