Tonghua Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd ("Dongbao Zixing"), a wholly-owned subsidiary of Tonghua Dongbao Pharmaceuticals Co., Ltd. ("Tonghua Dongbao"), has completed a pivotal Phase IIa clinical trial and obtained the summary report of the trial. The results of the study showed that the primary endpoints were achieved. The relevant information is announced as follows:

I. Basic information of the drug
1、Name: THDBH130 Tablets
2、Indications：Hyperuricemia and gout
3、Dosage form: Tablet
4、Specification：2.5mg、20mg
5、Registration Classification: Chemical 1
6、Applicant: Dongbao Zixing (Hangzhou) Biomedical Co.
7, drug clinical trial approval: State Drug Administration approved the issuance of drug clinical trial approval notice (2021LP02020).
The State Drug Administration approved the issuance of a notice of approval for clinical trial of the drug (2021LP02022; 2021LP02023), agreeing to carry out clinical trials.

II. R&D Investment
As at the date of this announcement, the Company has invested approximately RMB79.39 million in research and development in the Project.

III. R&D Status and Progress
After obtaining the approval for clinical trial of THDBH130 Tablets, the Company has completed a "Phase I clinical study on the safety, tolerability, pharmacokinetics and food effects of THDBH130 Tablets in healthy adult subjects with single and multiple dosing" in 2022 in accordance with the relevant guidelines for innovative drugs of chemical drugs in China, and the results of the study have reached a satisfactory level. "The results of the study met the primary endpoint objectives and demonstrated that THDBH130 tablets have a favorable safety and tolerability profile. Based on the results and data analysis of the Phase I clinical study of THDBH130, the Company initiated and completed "a multicenter, randomized, double-blind, placebo- and benzbromarone-controlled Phase IIa clinical study evaluating the safety, tolerability, preliminary clinical efficacy and pharmacokinetic/pharmacodynamic profiles of THDBH130 tablets in adult hyperuricemic patients with or without gout", and was awarded this clinical award. "A summary report of this clinical trial was obtained. The results of the study showed achievement of the primary endpoint objectives. In terms of efficacy, THDBH130 tablets dose-dependently lowered blood uric acid levels in patients with gout, with a comparable rate of achievement of 6 mg/dl of blood uric acid at the target dose compared to the positive control drug, phenylbromarone, but with some advantage at 4 or 5 mg/dl. Safety, the product has a good safety profile and is well tolerated. All drug-related adverse events were mild, with no grade 3 or higher adverse events. The incidence of adverse events at the target dose was similar to or lower than that of benzbromarone, and the incidence of acute gout was significantly lower during the dosing period. Taken together, the data from this study suggest a potential benefit in patients with deep uric acid remission and some patients with complicated/refractory gout. In conjunction with the Phase IIa study, the Company also conducted and completed a Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and glomerular filtration rate as measured by iohexol of THDBH130 Tablets administered as a single dose to adult male subjects with normal renal function and mild-to-moderate renal insufficiency. Phase I Clinical Study. The results of the study showed that there was no significant difference in the safety of the product in patients with different levels of renal function, and it was also verified that the product had no effect on the glomerular filtration rate at the dose used.

IV. Other Information
In recent years, patients with gout and hyperuricemia in China have shown a significant increase and younger trend. According to the "China Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout (2019)" and the data of the Sixth Population Census of the National Bureau of Statistics of the People's Republic of China, the overall prevalence of hyperuricemia in China is 13.3%, with the number of patients being about 177 million, and the overall incidence rate of gout is 1.1%, with the number of patients being about 14.66 million. 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 market size of China's gout medication market is expected to grow to RMB 10.8 billion. Currently, the two main treatments for hyperuricemia and gout are inhibiting uric acid production and promoting uric acid excretion. There is room for improvement in the effectiveness and safety of marketed URAT1 inhibitors.

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