Suzhou, September 26, 2021 - Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that on September 22 the Brazilian Health Regulatory Agency (ANVISA) granted an approval for the phase III clinical trial of proxalutamide to treat hospitalized COVID-19 patients. This is the third ANVISA-approved pivotal study sponsored by Kintor Pharma for the treatment of COVID-19 patients with proxalutamide.

The phase III trial (NCT05009732) is a randomized, double-blind, placebo-controlled, multi-regional clinical study, which is expected to enroll 1,030 patients, designed to evaluate the efficacy and safety of proxalutamide in hospitalized COVID-19 patients. The primary endpoint of the trial is the time to sustained recovery evaluated by day 30. The secondary endpoint of the trial is 30-day mortality.

Dr. Youzhi Tong, founder, Chairman, and CEO of Kintor Pharma, commented, “The approval of this study represents another milestone for Kintor Pharma. We have been planning to conduct the pivotal multi-regional clinical trial of proxalutamide for the treatment of hospitalized COVID-19 patients in more than ten countries. With this third approval by ANVISA, Brazil becomes the fourth country to approve the proxalutamide clinical trial after the United States, China and Philippines. We are hopeful this approval will pave the way for Kintor Pharma to apply for an emergency use authorization (EUA) and the eventual commercialization of proxalutamide for the treatment of COVID-19 in Brazil.”