Huya licenses early-stage, validated compounds for development, and in some cases the originator retains rights to the Chinese market. Depending on the quality of the preclinical data, Huya may conduct further efficacy and toxicity studies in the U.S. needed to support the filing of an IND application with the FDA.
Huya plans to move compounds through Phase II studies, then out-license promising candidates to pharmaceutical or biotechnology firms. This business model reduces the risk, costs, and time for drug development.
Among Huya’s licensed compounds is HBI-8000, a histone deacetylase (HDAC) inhibitor with antitumor properties. Researchers at Chipscreen Biosciences in Shenzhen discovered HBI-8000 using structure-based drug-design methods.
Huya’s second compound, HBI-3000, is a synthetic small molecule anti-arrhythmic derived from a traditional Chinese herbal medicine. It was licensed from the Shanghai Institute of Materia Medica. Huya will conduct Phase I and II trials for both compounds in the U.S., while Phase II studies are ongoing in China.
HBI-8000 is a benzamide small molecule HDAC inhibitor with potential for treating breast, prostate, and liver carcinomas, as well as non-small-cell lung cancer and non-Hodgkin lymphoma. HBI-8000 potently and selectively inhibits key cancer-related HDACs and shows broad spectrum antitumor activity, according to the company.
The anti-arrhythmic compound, HBI-3000, is a multi-ion channel blocker in development with formulations for oral and intravenous routes of administration to treat patients with atrial fibrillation. A serious concern for anti-arrhythmic drugs is an increased risk for sudden death in patients with underlying organic heart disease.
Early data on HBI-3000 suggests that it holds a safety advantage over current anti-AF drugs and may also treat ventricular arrhythmias.“Our hope is that these drugs will benefit patients with serious diseases,” says Dr. Gingras.
Huya has assembled a team of clinical and drug development advisors to help establish and execute a plan for moving each compound forward.
In addition to out-licensing opportunities, Huya also seeks global pharmaceutical partners to co-develop in-licensed novel clinical drug candidates that originate in China.