Suzhou, June 15, 2021 - Kintor Pharmaceutical Limited (HKEX:9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that the Brazilian Health Regulatory Agency (ANVISA) has approved the phase III clinical trial of proxalutamide to treat male patients with mild or moderate COVID-19 symptoms on June 11, 2021[1]. The pivotal phase III study was approved by the Brazilian National Research and Ethics Committee (CONEP) on May 27, 2021[2].

The phase III trial (NCT04869228) is a randomized, double-blind, placebo-controlled, multi-regional study, designed to evaluate the efficacy and safety of proxalutamide in male patients with mild or moderate COVID-19 symptoms. The primary endpoint for the trial is the percentage of subjects requiring oxygen by day 28. Kintor expects the first patient dosing for the trial to commence in July 2021.

The Brazilian study is the third pivotal study of proxalutamide in the treatment of COVID-19 sponsored by Kintor. The Brazilian approval came along with the U.S. Food and Drug Administration’s (FDA) clearance of two pivotal trials studying proxalutamide’s treatment of U.S. COVID-19 outpatients and inpatients.

Dr. Tong Youzhi, the founder, Chairman, and CEO of Kintor Pharmaceutical, commented, “We are delighted to receive the approval from ANVISA and CONEP for this Brazilian phase III clinical trial of proxalutamide in COVID-19 patients. Once the previously reported results of the investigator-initiated trial (IIT) in Brazil became available, Kintor itself filed a pre-IND application with ANVISA as part of a multi-regional clinical trial. We look forward to continuing our positive relationship with the Brazilan regulators and expect this approval will pave the way for Kintor to apply for an emergency use authorization (EUA) and the eventual commercialization of proxalutamide for the treatment of COVID-19 in Brazil.”

[1] ANVISA ：https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/pesquisaclinica/arquivos/ensaios-clinicos-covid.pdf/view

[2] CONEP CAAE: 46013221.7.1001.5412; Opinion Number: 4,737,494