Proxalutamide Phase III Clinical Trial for the Treatment of COVID-19 Patients Approved by FDA

    SUZHOU, China, March 5, 2021 /PRNewswire/ -- Kintor Pharmaceutical Limited (HKEX: 9939) is pleased to announce that the Investigational New Drug (IND) application of the phase III clinical trial of Proxalutamide's treatment of male COVID-19 outpatients has been approved by the United States Food and Drug Administration (FDA).

    Kintor has been the first China-based biopharma company whose small-molecule novel drug was granted with a phase III clinical trial approval by the FDA for the treatment of COVID-19.

    Dr. Tong Youzhi, the Founder, Chairman and CEO of Kintor Pharmaceutical, commented, "We are delighted to receive this phase III clinical trial approval from the FDA. This has been the first phase III clinical trial approval from the FDA since Kintor's inception in 2009. We are driving at full force to execute clinical operations of this phase III clinical trial. According to the existing clinical data, the efficacy and safety profiles of Proxalutamide in the treatment of patients with COVID-19 are outstanding. We strive to launch Proxalutamide to the market for COVID-19 treatment as soon as possible, and help people around the globe to defeat COVID-19."

    About Kintor Pharmaceutical Limited

    Founded in 2009, Kintor Pharmaceuticals aims to become a leading enterprise in the R&D and commercialization of "best-in-class" and "first-in-class" innovative therapies. The Company initially focused on androgen receptor (AR) related diseases and researched and developed product portfolios in multiple channels covering cancers with a globally high incidence and illnesses yet to meet their clinical requirements, such as COVID-19, prostate cancer, breast cancer, liver cancer ,hair loss and acne. Kintor Pharmaceuticals has prospectively developed a diversified product pipeline that includes small molecule innovative drugs, bio-innovative drugs and combination therapies, including 5 products that are undergoing clinically researched androgen receptor antagonists, ALK-1 monoclonal antibody, mTOR kinase inhibitors and Hedgehog inhibitors, as well as PD-L1/TGF-β dual-targeting antibody, AR-Degrader and c-Myc inhibitors that are undergoing preclinical research. Globally, the Company has more than 60 issued patents or under review, many of which are listed as the "Major New Drugs Discovery" in National 12th and 13th Five-Year Plans. On 22 May 2020, the Company was officially listed on the Hong Kong Stock Exchange with the stock ticker 9939.HK. Please visit for more information.

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