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Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. ("the Company" or "Tonghua Dongbao"), recently completed a Phase I pivotal clinical trial on its dual-target inhibitor for gout (THDBH151 Tablets) and produced a clinical trial report. The results demonstrate that the trial has reached its primary endpoint.

The results of the Company's Phase I clinical study on the safety, tolerability, pharmacodynamics (PD)/pharmacokinetics (PK), and food effects of THDBH151 tablets in healthy adult subjects following single or multiple dosing show that this product is safe and well-tolerated in healthy Chinese adults. The overall incidence of adverse events was similar to or slightly lower than that seen with placebo, with all adverse events being mild (Grade 1). PD data indicates that the product significantly reduces blood uric acid levels, with a clear dose-response relationship. Besides, the treatment significantly increased serum xanthine levels and urinary uric acid excretion. This indicates that the product effectively inhibits both xanthine oxidase (XO) and the urate transporter (URAT1), affirming its role as a dual-target XO/URAT1 inhibitor. PK data shows that the product has favorable PK properties and is suitable for once-daily dosing.

About THDBH151 Tablets

THDBH151 is a dual-target inhibitor for gout. Due to its special mechanism of action, it can both reduce uric acid production by inhibiting xanthine oxidase (XO) and increase uric acid excretion by inhibiting the URAT1 transporter in the renal tubules. This mechanism improves efficacy and reduces side effects, leading to significantly higher medication adherence. THDBH151 has the potential to become the best-in-class drug of its kind. There are no similar products available on the market in China or worldwide.

About gout and hyperuricemia

The prevalence of gout and hyperuricemia has obviously increased in China, especially among young people, in recent years. According to the Chinese Guidelines for the Treatment of Hyperuricemia and Gout (2019) and data from the 6th national population census conducted by the National Bureau of Statistics, the overall prevalence of hyperuricemia in China is 13.3%, with approximately 177 million patients, while the overall prevalence of gout is 1.1% with about 14.66 million patients. Hyperuricemia has become the fourth most common metabolic disorder, following diabetes, hypertension, and hyperlipidemia. Gout has also become the second most common metabolic disease after diabetes.

A Frost & Sullivan analysis reveals that the number of people in China with hyperuricemia and gout will continue to increase, respectively reaching 239 million and 52.2 million in 2030, and the Chinese gout drug market is expected to grow to RMB 10.8 billion. There are two main treatments for gout and hyperuricemia: inhibiting uric acid production and increasing uric acid excretion.