CSBIO(SZ:300255) Zhi Tong Cai Jing·2026-01-09 11:54Core Viewpoint - Changshan Pharmaceutical (300255.SZ) has received approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Enoxaparin Sodium Injection, indicating a significant milestone for the company in the U.S. market [1] Group 1: Product Approval - The Enoxaparin Sodium Injection is indicated for the prevention of venous thromboembolism, particularly related to orthopedic or general surgery [1] - It is also used for the treatment of established deep vein thrombosis, with or without pulmonary embolism, in clinically stable patients [1] - The drug can be used in combination with aspirin for the treatment of unstable angina and non-Q-wave myocardial infarction [1] - Additionally, it is utilized in hemodialysis to prevent thrombosis during extracorporeal circulation [1]