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On December 15, 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 notice of approval (No. CXHL2101548 and CXHL2101549) from the Center for Drug Evaluation of the National Medical Products Administration for the clinical trial of its URAT1 inhibitor (THDBH130 Tablets).

THDBH130 Tablets are a drug that targets URAT1 for the treatment of gout and hyperuricemia, which are the proposed indications in this application. Hyperuricemia is considered necessary but not sufficient for the development of gout. Gout is often associated with obesity, diabetes, hypertension, hyperlipidemia, and cardiovascular disease (CVD).

Prevalence of hyperuricemia has increased in China, especially among young people, in recent years. The White Paper on Hyperuricemia and Gout Trends in China (2021) released by CBNData shows that the overall prevalence of hyperuricemia and gout in China is 13.3% (about 177 million patients) and 1.1% (about 14.66 million patients), respectively. Gout has become the second most common metabolic disease after diabetes.

China's gout therapeutics market is promising. 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. Among the existing gout drugs, uricosuric drugs targeting URAT1 primarily include benzbromarone and lesinurad. The latter is not yet available in China. According to data from Yaozhi.com, benzbromarone contributed 15.91% of the gout drug sales in public healthcare institutions in 2020.

Chinese patients have an urgent need for effective and safe gout drugs. According to the Guidelines for the Combined Treatment of Hyperuricemia and Gout, the urate-lowering drugs available on the market show remarkable effects in gout. But the need for long-term treatment and a large number of adverse effects lead to poor medication adherence and hence recurrent gout attacks. For example, benzbromarone may cause liver damage, and febuxostat is associated with an increased risk of adverse cardiovascular events. According to available trial 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 SGLT1/SGLT2/DPP4 triple inhibitor was approved for clinical trials in June. With THDBH130 Tablets approved for clinical trials, the Company further consolidates its gout drug R&D and takes a solid step forward in the field of novel endocrine drugs.

Upholding the philosophy of "Establishing a Global Brand Through Consistent Innovation," Tonghua Dongbao 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 its vision of becoming an explorer and leader of novel drugs R&D in the field of endocrinology as soon as possible.