Dong Bao Zi Xing Ltd., a wholly-owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. (the "Company"), has recently completed a pivotal Phase I clinical trial of a dual-target XO/URAT1 inhibitor for gout (THDBH151 tablets) and obtained a clinical trial summary report, which shows that the study results have reached the primary endpoint. The results of the study showed that the primary endpoints were met.

The results of the "Phase I Clinical Study of the Safety, Tolerability, Pharmacogenetics/Pharmacodynamics and Effect of Food of THDBH151 Tablets in Healthy Adult Subjects with Single and Multiple Doses" conducted by the Company showed that the product was safe and well-tolerated in healthy Chinese adult subjects, with overall adverse event rates similar to or slightly lower than those of placebo, and that all adverse events were similar to or lower than those of placebo. The overall adverse event rate was similar to or slightly lower than that of placebo, and all adverse events were grade 1. The pharmacokinetic index (PD) showed that the product could significantly reduce the serum uric acid level of the subjects, and the quantitative effect relationship was obvious. It was also observed that this product significantly increased serum xanthine levels and increased urinary uric acid excretion levels after administration. It was shown that the product inhibited both xanthine oxidase (XO) and urate transporter (URAT1) in the human body, which verified that the product was a true XO/URAT1 dual-target inhibitor. Pharmacokinetic index (PK) shows that the product has good pharmacokinetic properties, good drug formation, and fully meets the needs of once-daily administration.

About THDBH151 Tablets

The Company's THDBH151 Tablet is a gout dual-target XO/URAT1 inhibitor, because of its special advantages in the mechanism of action, it can both inhibit xanthine oxidase to reduce the production of uric acid from the source, and inhibit the reabsorption of uric acid by the renal tubular URAT1 transporter to accelerate the elimination of uric acid from the body. In addition, THDBH151 tablets are expected to become the best-in-class drug in the same field by balancing the roles of XO/URAT1 in lowering uric acid, improving the efficacy of the drug while reducing the side effects, and greatly improving the compliance of patients. Currently, there are no similar products on the market at home and abroad.

About Gout/Hyperuricemia

In recent years, gout and hyperuricemia patients in China are on the rise and getting younger. According to the "China Hyperuricemia and Gout Diagnosis and Treatment Guidelines (2019)" and data from the Sixth Population Census of the National Bureau of Statistics of China, the overall prevalence of hyperuricemia in China is 13.3%, with a prevalence of approximately 177 million people, and the overall incidence of gout is 1.1%, with a prevalence of approximately 14.66 million people. Hyperuricemia has become the "fourth highest" disease after diabetes, hypertension and hyperlipidemia, and gout has become the second largest metabolic disease after diabetes.

According to Frost & Sullivan's analysis, the number of people suffering from hyperuricemia and gout in China will continue to increase in the future, reaching 240 million/52.2 million people in 2030, and the corresponding gout drug market size in China is expected to grow to 10.8 billion yuan. Currently, the two main treatments for hyperuricemia and gout are inhibiting uric acid production and promoting uric acid excretion.

https://mp.weixin.qq.com/s/0accHRBS2imyWKaKQqPyqQ