Policy & Regulation
Kintor Pharmaceutical's Proxalutamide granted US FDA approval for Investigational New Drug application of phase III clinical trial
8 March 2021 -

The United States Food and Drug Administration (FDA) has granted approval to the Investigational New Drug (IND) application of the phase III clinical trial of China-based Kintor Pharmaceutical Limited's (HKEX: 9939) Proxalutamide, intended for the treatment of male COVID-19 outpatients, it was reported on Friday.

The company says that it is the first China-based biopharma company whose small-molecule novel drug has received a phase III clinical trial approval by the US FDA for the treatment of COVID-19.

Dr Tong Youzhi, the founder, chairman and CEO of Kintor Pharmaceutical, said, '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.'

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