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]

Core Viewpoint - The approval of the abbreviated new drug application (ANDA) for injectable micafungin by the U.S. FDA allows the company to produce and sell the product in the U.S. market [1] Group 1: Company Announcement - The company’s wholly-owned subsidiary, Zhejiang Hisun Pharmaceutical Co., Ltd. (referred to as "Hisun Hangzhou"), has received notification from the U.S. FDA regarding the approval of its ANDA for injectable micafungin [1] - This approval signifies a significant milestone for Hisun Hangzhou, enabling it to enter the U.S. market with this product [1] Group 2: Product Indications - 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]

Core 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]

Core Viewpoint - Haizheng Pharmaceutical's wholly-owned subsidiary, Haizheng Hangzhou, has received FDA approval for the abbreviated new drug application of injectable micafungin, allowing production and sales in the U.S. [1] Group 1: Product Details - The approved drug is available in two specifications: 50mg and 100mg, and is indicated for the treatment and prevention of various candidiasis infections [1] - The global sales forecast for 2024 is approximately $208 million, with the U.S. market contributing about $67.57 million [1] - For the period from January to September 2025, global sales are projected to be around $143 million, with U.S. sales estimated at $46.23 million [1] Group 2: Investment and Financials - The company has invested approximately 17.94 million yuan in this project [1]