Policy & Regulation
Kintor Pharmaceutical receives IND application approval for pivotal pyrilutamide (KX-826) study
25 November 2021 -

Kintor Pharmaceutical Limited (HKEX: 9939), a China-based clinical-stage biotechnology company, announced on Wednesday that it has received IND application approval from the National Medical Products Administration (NMPA) for the pivotal study (phase III stage) of pyrilutamide (KX-826), a potential first-in-class drug developed by the company, intended to treat patients with male androgenetic alopecia.

The product is the first androgen receptor antagonist that has entered the phase III clinical trial for androgenetic alopecia treatment in China and globally.

The pivotal study, a randomised, double-blinded, placebo-controlled, multi-regional phase III clinical trial, is aimed at assessing the efficiency and safety of the product for treating male androgenetic alopecia patients in China. The company has enrolled 416 patients in the trial that is being conducted for a duration of 24 weeks. The primary endpoint is the change from baseline in non-vellus target area hair count (TAHC) at the end of week 24.

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