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Recently, Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. (hereafter referred to as "Tonghua Dongbao" or "the Company") successfully dosed the first patient in the Phase IIa clinical trial of the dual inhibitor for gout (THDBH151 tablets), the first XO/URAT1 dual inhibitor for gout that has entered the Phase II clinical trial stage in China.

Gout and hyperuricemia treatment is a key focus and priority within the Company's endocrine and metabolism portfolio. This dual inhibitor is among the Company's key investigational novel drugs for gout/hyperuricemia treatment. The dosing of the first patient in the Phase IIa clinical trial marks the Company's another solid step forward in this field. The Company is committed to accelerating the clinical trials of this product to address substantial unmet clinical needs, thereby offering better treatment options to patients.

About Phase IIa Clinical Study on THDBH151 Tablets

After securing approval from the National Medical Products Administration (NMPA), the THDBH151 tablets successfully completed the Phase I clinical trial. This trial confirmed the safety and tolerance of the tablets and demonstrated their significant efficacy in reducing serum uric acid levels by simultaneously inhibiting xanthine oxidase (XO) and urate transporter (URAT1), showcasing a clear dose-response relationship.

In accordance with the guidelines for novel chemical drugs in China, the Company has launched "a multicenter, randomized, double-blind, double-dummy, febuxostat-and-placebo-controlled Phase IIa clinical study to evaluate the safety, tolerance, preliminary clinical efficacy, and pharmacokinetic/pharmacodynamic characteristics of THDBH151 tablets in adult patients with gout." The primary aim of the study is to assess the safety, tolerance, and preliminary efficacy of orally administered THDBH151 tablets in these patients. The secondary aims are to evaluate the uric acid-lowering effect of the tablets, their impact on gout attacks, and to compare these effects with those of febuxostat in adult gout patients. The trial is working out well, with the first patient dosed recently.

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.