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Tonghua Dongbao announces NMPA acceptance of its clinical trial application for URAT1 inhibitor (THDBH130 Tablets)
Date：2021-10-20
Author：Dongbao
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On October 11, 2021, Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd. (Dongbao Zixing), a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. (the “Company” or “Tonghua Dongbao”), received the notification of acceptance from the Center for Drug Evaluation of the National Medical Products Administration on the application for the clinical trial of URAT1 inhibitor (THDBH130 Tablets). The acceptance numbers are CXHL2101548 Guo and CXHL2101549 Guo.
THDBH130 Tablets are a drug that targets URAT1 for the treatment of gout and hyperuricemia. China sees rapidly growing unmet needs in the treatment of gout and hyperuricemia. According to the Chinese Guidelines for the Treatment of Hyperuricemia and Gout (2019), the overall prevalence of hyperuricemia in China is 13.3%. And gout has a prevalence of 1-3%, becoming the second most common metabolic disease after diabetes.
Current uricosuric drugs targeting URAT1 primarily include benzbromarone and lesinurad, which are not yet available in China. According to data from Yaozhi.com, in 2020, the sales of gout drugs in urban public hospitals and retail pharmacies in China were RMB 1.91 billion and RMB 830 million, respectively. Benzbromarone contributed 15.91% of the gout drug sales of public healthcare institutions in 2020.
According to the Guidelines for the Combined Treatment of Hyperuricemia and Gout, the urate-lowering drugs available on the market show remarkable efficacy in the treatment of gout. But the need for long-term medication and more adverse effects lead to poor medication adherence and hence recurrent gout attacks. According to available animal data, Tonghua Dongbao's URAT1 inhibitor demonstrates high potency, selectivity, and safety.
As China enacts policies to encourage drug innovation, the Company is making a strong foray into the field of novel drugs, while maintaining a focus on the R&D of drugs for diabetes and other major endocrine diseases. This March, the Company unveiled three novel diabetes drugs, among which, the world's first triple SGLT1/SGLT2/DPP4 inhibitor was approved for a clinical trial in June. The acceptance of the clinical trial application for THDBH130 Tablets marks a solid step forward in the Company's long-term effort in gout drug R&D and continued expansion in the field of novel endocrine drugs.
Adhering to the philosophy of "Establishing a Global Brand Through Consistent Innovation", we will continue to focus on the R&D of cutting-edge and key technology for treating diabetes and other endocrine diseases and promote innovation to achieve our vision of being an explorer and leader of novel drugs R&D in the field of endocrinology as soon as possible.
