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Hinova's Clinical Trial Application for the Combination of HP501 Sustained-release Tablets and xanthine oxidase inhibitors in the Treatment of Hyperuricemia/Gout was Accepted by NMPA

Time:2023-02-06 Source:海创药业 Hits:1669

The clinical trial application for the combination of HP501 sustained-release tablets and xanthine oxidase inhibitors for the long-term treatment of primary hyperuricemia has been recently accepted by the National Medical Products Administration (NMPA).

Currently, there are three categories of drugs used to treat hyperuricemia: 1) Xanthine Oxidase (XO) inhibitors could reduce blood uric acid levels by inhibiting uric acid production, but in approximately 40-60% of patients, treatment with xanthine oxidase inhibitors such as allopurinol or febuxostat alone does not control blood uric acid concentrations to the desired level. 2) uric acid oxidases lower blood uric acid levels by inducing uric acid decomposition. However, they are prone to antibody production and have limited effect in the chronic treatment of hyperuricemia. 3) Urate Anion Transporter 1 (URAT1) inhibitors promote uric acid excretion and reduce urate reabsorption via inhibiting the activity of URAT1, but the marketed drug benzbromarone has a risk of causing serious liver toxicity.

HP501 is a highly active and selective URAT1 inhibitor developed by Hinova. The combination of HP501 and xanthine oxidase inhibitors, will more efficiently control blood uric acid levels. The acceptance of clinical trial application is the combination of HP501 with xanthine oxidase inhibitors for the long-term treatment of primary hyperuricemia.

In recent years, hyperuricemia/gout has become more common all over the world.In 2020, 930 million people worldwide suffered from hyperuricemia and gout, and in china, it has become the second most common metabolic disease, and the population was more than 170 million. Current marketed drugs for hyperuricemia/gout have safety issues. Thus, the development of safer, efficient hyperuricemia/gout drugs could address this unmet clinical needs.

Since its first clinical trial approval, HP501 had undergone several phase I/II trials for the treatment of hyperuricemia/gout as a single agent, and HP501 demonstrated good efficacy and safety according to the available clinical trial data.

“We focus on the development of innovative drugs in areas such as oncology and metabolic diseases. Hyperuricemia is a chronic metabolic disease requiring long-term medication, so the drug safety is of particular importance,” said Yuanwei Chen, Ph.D., President and CEO of Hinova. “For this reason, we have put big effort on screening the safety of the drug during the development of HP501. With this clinical study application for the HP501 in combination with xanthine oxidase inhibitors, we hope to provide a safer and more effective treatment option for more patients with hyperuricemia and gout.”

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About hyperuricemia/gout

Excessive intake of purine compounds and enhanced synthesis or reduced excretion of uric acid in vivo are the major causes of hyperuricemia. Uric acid in vivo is excreted through the kidneys, and reduced uric acid excretion leads to hyperuricemia mainly. Chronic hyperuricemia will cause Gout with the deposition of urate crystals under the skin and in the joints.

Frost & Sullivan predicts that by 2030 there will be 1.42 billion people with hyperuricemia and gout worldwide, and the number of patients in China will reach 240 million. The global market will be $7.7 billion, and the market in China will be RMB 10.8 billion. 


About HP501

HP501 is a small molecule inhibitor of URAT1 developed by Hinova for the treatment of hyperuricemia/gout. Hinova introduced the strict toxicity evaluation of candidate compounds on liver and kidney in the early development, and the side effects were further reduced through special formulations. 

Available Phase I~II clinical trial data have demonstrated the efficacy and safety of HP501 in the treatment of hyperuricemia/gout.


About Hinova

Hinova is an international and clinical-stage biopharmaceutical company focused on developing novel therapeutics for cancers and metabolic diseases. Hinova has committed to the discovery and development of innovative medicines for patients globally through deuteration and targeted protein degradation technologies.