Jiangxi Synergy Pharmaceutical Co Ltd

Jiangxi Tonghe Pharmaceutical Co., Ltd. announced that it recently received a registration approval letter from the U.S. Food and Drug Administration for its Mirabegron active pharmaceutical ingredient, with Drug Master File number 031661. Mirabegron is a selective beta-3 adrenergic receptor agonist used to treat overactive bladder. This approval indicates that the FDA has completed the technical review of the API's DMF file, which can meet the ANDA filing requirements of associated formulation customers. The company stated that this will help expand the market, develop customers, and further grow its international business, but also noted that sales of related products are susceptible to factors such as changes in the market environment and exchange rate fluctuations.

Jiangxi Tonghe Pharmaceutical Co., Ltd. recently received GMP compliance certificates for the active pharmaceutical ingredients mirabegron and empagliflozin from Australia's Therapeutic Goods Administration. This marks the company's first time passing a TGA GMP certification. The certificate number is MI-2025-CE-02875-1, valid until August 3, 2028. Mirabegron is used to treat overactive bladder, and empagliflozin is used to treat type 2 diabetes. The certification indicates that the company's quality system and production environment facilities have been recognized by the TGA, which will help promote international market development and gain access to the Australian market. The company also noted that international sales may be affected by factors such as changes in the market environment and exchange rate fluctuations.

Tonghe Pharmaceutical announced that its active pharmaceutical ingredients azilsartan medoxomil potassium and edoxaban tosylate recently passed the drug GMP compliance inspection by the Jiangxi Provincial Medical Products Administration. Azilsartan medoxomil potassium is used to treat adult primary hypertension, while edoxaban tosylate is an oral anticoagulant mainly used to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as to treat or prevent deep vein thrombosis and pulmonary embolism. The inspections were conducted from January 24 to January 27, 2026, and from June 16 to June 18, 2026, respectively. In the first quarter of 2026, Tonghe Pharmaceutical achieved revenue of 184 million yuan and a net profit attributable to the parent company of 18.78 million yuan.