南京健友生化制药股份有限公司关于子公司产品亚硒酸注射液获得美国FDA批准的公告

Core Viewpoint - The company has received ANDA approval from the FDA for its sodium selenite injection, which is expected to enhance its international product pipeline and positively impact its operational performance if successfully marketed in the U.S. [1][4] Group 1: Drug Information - Drug Name: Sodium Selenite Injection [2][6] - Indication: For adult and pediatric patients requiring parenteral nutrition, serving as a source of selenium when oral or enteral nutrition is not feasible, insufficient, or contraindicated [1][2] - Dosage Form: Injection [6] - Specification: 600 mcg/10 mL [6] - ANDA Number: 219472 [6] Group 2: Approval Details - The ANDA application for sodium selenite injection was approved by the FDA on February 4, 2026 [2] - The reference formulation is held by AMERICAN REGENT INC, which received FDA approval for its product, SELENIOUS ACID, on April 30, 2019 [2] - Currently, five other companies have also received approval for sodium selenite injection in the U.S. market [2] Group 3: Financial Investment - The company has invested approximately RMB 6.5605 million in the research and development of the sodium selenite injection project [3] Group 4: Impact on Company - The newly approved product enriches the company's international product pipeline and strengthens its market presence [4] - Successful market entry in the U.S. is anticipated to have a positive effect on the company's operational performance [4]