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Kintor Pharma gets US FDA approval to begin phase III trial of Proxalutamide to treat Covid-19

Monday, March 8, 2021, 16:30 Hrs  [IST]

Kintor Pharmaceutical Limited announced 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.”

Founded in 2009, Kintor Pharmaceuticals concentrates on the R&D and industrialization of “best-in-class” and “first-in-class” innovative drugs and strives to become a leading enterprise in the R&D and commercialization of innovative therapies.


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