CSBIO(SZ:300255) Ge Long Hui A P P·2026-01-09 12:28Core Viewpoint - Changshan Pharmaceutical (300255.SZ) has received approval from the U.S. Food and Drug Administration (FDA) for its new drug application (ANDA) for Enoxaparin Sodium Injection, which is used for the prevention and treatment of venous thromboembolism and other related conditions [1]. Group 1: Product Approval - The FDA approval pertains to Enoxaparin Sodium Injection, which is indicated for the prevention of venous thromboembolic diseases, particularly related to orthopedic or general surgery [1]. - The drug is also used for the treatment of established deep vein thrombosis, with or without pulmonary embolism, in clinically stable patients, excluding those requiring surgical intervention or thrombolytic therapy for pulmonary embolism [1]. - Additionally, it is indicated for use in combination with aspirin for the treatment of unstable angina and non-ST elevation myocardial infarction [1]. Group 2: Clinical Applications - Enoxaparin Sodium Injection is utilized in hemodialysis to prevent thrombosis during extracorporeal circulation [1].