Proxalutamide's Pivotal Study of Treating COVID-19 Male Outpatients Sponsored by Kintor was Approved by ANVISA and CONEP in Brazil

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."

About Proxalutamide (GT-0918)

Proxalutamide is a nonsteroidal antiandrogen -specifically, a selective high-affinity silent antagonist of the androgen receptor - that is under development for the potential treatment of COVID-19, prostate cancer, and breast cancer.

About Kintor Pharmaceutical Limited

Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancer, alopecia and acne. For more information, visit www.kintor.com.cn.

[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