Jiuzhou subsidiary gains drug registration for Edoxaban Tosylate tablets

Jiuzhou Biological Medicine (Taizhou) Co., Ltd., a wholly-owned subsidiary of Zhejiang Jiuzhou Pharmaceutical Co., Ltd., has obtained drug registration certificates for Edoxaban Tosylate tablets (60mg and 30mg) from the National Medical Products Administration. This approval is for domestic production of a Class 4 chemical drug. The tablets are intended for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment or prevention of deep vein thrombosis and pulmonary embolism.

Edoxaban Tosylate tablets were first developed by Japan's Daiichi Sankyo and launched in Japan in April 2011. Other domestic manufacturers holding registration certificates for this drug include Hainan Simcere Pharmaceutical Co., Ltd. and Shandong Shinetime Pharmaceutical Co., Ltd. According to public data, domestic sales of Edoxaban Tosylate tablets in 2023 were approximately RMB 361 million.

Zhejiang Jiuzhou Pharmaceutical has invested approximately RMB 14.41 million in the research and development of Edoxaban Tosylate tablets. The company states that obtaining these registration certificates will enrich its product pipeline and enhance its market competitiveness. However, the company also notes that the production and sales of pharmaceutical products are subject to market, policy, and supply-demand factors, which introduce uncertainties.