Jiuzhou pharmaceutical wins approval for edoxaban raw material

Zhejiang Jiuzhou Pharmaceutical Co., Ltd. announced it has received approval from the National Medical Products Administration for the marketing authorization application of Tosylate Edoxaban, a chemical raw material. This approval confirms the raw material meets registration requirements, with quality standards, labeling, and production processes to be implemented as specified.

Tosylate Edoxaban is an oral anticoagulant used to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment or prevention of deep vein thrombosis and pulmonary embolism. Jiuzhou Pharmaceutical submitted the application in July 2024 and has invested approximately RMB 6.69 million in its research and development. The raw material is listed as “A” on the CDE raw material and excipient registration platform.

This approval is expected to enrich the company's product structure and boost its market competitiveness. However, the company noted that the pharmaceutical industry's market environment, policies, and supply-demand dynamics could introduce uncertainties regarding future sales and production.