Kintor Proxalutamide's COVID-19 Clinical Trial Shows Significant Reduction in Hospitalization and Ventilation Rates

SUZHOU,China,Dec. 12,2020 -- Kintor Pharmaceutical Limited(HKEX: 9939)ispleased to updatethe preliminary analysis of the Proxalutamide'sclinical trial for the treatment of COVID-19.

Proxalutamide is a new androgen receptor (AR) antagonist developed inbyKintor Pharmaceuticaland is currently undergoing phase I-III clinical trials in China and theUS for the treatment of prostate cancer and breast cancer. Following the outbreak of COVID-19,the companyfound that Proxalutamide could limit the expression of ACE-2 and TMPRSS2,which plays a critical role for SARS-CoV-2 to bind and enter host cells in the lung.

The Clinical Trialis a randomized,double-blind and placebo-controlled clinical trial,designedto explore the role of anti-androgen agentfor the treatment of COVID-19. It is an investigator initiated trial (IIT). The preliminary analysis included 319 enrolled subjects. The co-primary endpoints of the clinical trial are the percentage of subjects hospitalized with COVID-19 and the COVID-19 Ordinal Outcome Scale(a 7-point ordinal scale published by theWorld Health Organization,such asmechanical ventilation usageanddeath)in 30 days. The preliminary outcome of the trial showed that the hospitalization ratewas0.8% for theProxalutamide arm,compared to 27.0% for the control arm,the percentage of mechanical ventilation usage was 0% for Proxalutamide arm versus 9.0% for the control arm,and the percentage of death was 0% for Proxalutamide arm versus 2.0% for the control arm.Both co-primary efficacy endpoints were achieved. The final clinical study report of the trial is expected in January 2021.

The table below is the comparison between Proxalutamide arm and control arm in terms of percentage of positive in rtPCR test between day 0 and day 30 as of December 8,2020.The Proxalutamide arm has shown greater reduction of viral load starting fromday 7,and this trend continued until the results of day 30.The rtPCR test,so called RT-PCR test,is a real-time reverse transcription polymerase chain reaction test for the qualitative detection of nucleic acid from SARS-CoV-2,of which positive results are indicative of the presence of SARS-CoV-2 RNA.

Proxalutamide arm

Control arm

rtPCR positive (%) Day 0

100%

100%

rtPCR positive (%) Day 3

100%

100%

rtPCR positive (%) Day 7

42.5%

93.8%

rtPCR positive (%) Day 14

15.0%

56.2%

rtPCR positive (%) Day 30

10.0%

43.8%

Dr. Tong Youzhi,the founder,Chairman and CEO of Kintor Pharmaceutical,said,"Proxalutamide,as an AR antagonist,is used for the treatment of tumor and AR related non-tumor diseases.We are glad to see the positive results in COVID-19 clinical trials with Proxalutamide,which is expected to reduce the probability of the progression from mild to severe in COVID-19 patients by lowering the expression of TMPRSS2 and ACE-2 proteins. We are actively initiating MRCT phase III clinical trials in countries such as the US and China,and hope to obtain an emergency use authorization (EUA),in this way more COVID-19 patients would benefit from Proxalutamide."