Suzhou, May 18, 2021 - Kintor Pharmaceutical Limited (HKEX.9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has greenlighted proxalutamide's phase III clinical trial of hospitalised COVID-19 patients to be conducted, which will recruit both male and female patients. Separately, the FDA agreed to the addition of female patients to its ongoing proxalutamide phase III clinical trial in outpatients with mild to moderate COVID-19 illness. The company will publish and update details of these pivotal studies at ClinicalTrials.gov.

Dr. Youzhi Tong, Founder, Chairman, and CEO of Kintor Pharmaceuticals, commented, "We have been planning to conduct a pivotal multi-regional clinical trial of proxalutamide for the treatment of hospitalised COVID-19 patients in approximately ten countries. That the US FDA greenlighted the proxalutamide phase III clinical trial for hospitalised patients to be conducted paves the way for us to accelerate the study process. At the same time, the FDA agreed to include female subjects in our ongoing phase III clinical trial of outpatients with mild to moderate COVID-19 illness. We look forward to reporting proxalutamide's progress in helping to combat the global COVID-19 pandemic."