HaiChuang Pharma's AR Inhibitor HC-1119 Receives ANVISA Approval for Phase II/III Clinical Trial in Hospitalized COVID-19 Patients in Brazil

Editor’s Note: This article is reprinted from Medicine Panorama, with authorization granted to VCBeat.

On July 12, HaiChuang Pharmaceuticals announced that its application for the Phase 2/3 clinical trial of HC-1119 for the treatment of hospitalized COVID-19 patients had been approved by the Brazilian Health Regulatory Agency (ANVISA), paving the way for the formal commencement of the related clinical trials in Brazil. Reportedly, this placebo-controlled trial aims to evaluate the efficacy and safety of HC-1119 in treating hospitalized COVID-19 patients when administered alongside standard care. According to the press release, if this clinical trial proves successful, it could provide a therapeutic option for patients with COVID-19.

HC-1119, an androgen receptor (AR) inhibitor, is one of Haichuang Pharmaceutical’s core investigational products. Global multicenter Phase 3 clinical trials and domestic Phase 3 clinical trials in China for the treatment of prostate cancer are being conducted concurrently. The approval of this clinical trial related to COVID-19 treatment will facilitate further development of its indications and expand the therapeutic scope of this product.

Founded in 2013 by Dr. Chen Yuanwei, who serves as its Founder and Chairman, Haichuang Pharmaceutical is a global innovative pharmaceutical company focused on cancer and metabolic diseases. The company is dedicated to the research, development, and production of innovative drugs with global rights that address significant unmet clinical needs. Since its inception, the company has secured investments from numerous renowned institutions.

Currently, HaiChuang Pharma has established four core technology platforms: the PROTAC-targeted protein degradation platform, the deuterated drug development platform, the targeted drug discovery and validation platform, and the lead compound optimization and screening platform. The company also has 10 products in its pipeline. Among them, HC-1119, indicated for the treatment of castration-resistant prostate cancer, is currently undergoing two Phase III clinical trials in China and globally; HP501, indicated for the treatment of hyperuricemia and gout, is currently undergoing a Phase II clinical trial in China.