Suzhou, Dec. 30, 2020--Kintor Pharmaceutical Limited (HKEX:9939) is pleased to announce that it took only more than three months for the Company to complete the enrolment of 120 patients required for the Phase II clinical trial for Pyrilutamide (tincture） for the treatment of androgenetic alopecia since its launch in September this year, which is being developed by the Company as a potential first-in-class drug.

Pyrilutamide is a kind of topical androgen receptor (AR) antagonist, the clinical trials of which for the treatment of androgenic alopecia have been carried out in China and the United States. The Phase II Clinical Trial conducted in China is a multicentre, randomised, double-blind, placebo control clinical study to assess the safety and efficacy of Pyrilutamide for treatment of Chinese adult male androgenetic alopecia patients. The Group enrolled a total of 120 male androgenetic alopecia patients from eight centers nationwide for the study and randomly assigned them into four groups (including three dose groups and one placebo group) with 30 patients in each group. The four patient groups were administered with 2.5 mg Pyrilutamide twice-a-day (BID), 5 mg Pyrilutamide once-a-day (QD), 5 mg Pyrilutamide twice-a-day (BID) and placebo, respectively. The Group will evaluate the group exposure of every six weeks from the commencement of the administrating the test drug until the end of the 24th week.

In addition, Pyrilutamide’s phase Ib clinical trial for indication of androgenetic alopecia initiated in the United States was completed on August 3, 2020. In September 2020, Pyrilutamide’s (gel formula) clinical trial for indication of acne vulgaris and androgenetic alopecia was approved by the National Medical Products Administration (NMPA) in the PRC.

Dr. Youzhi Tong, the founder, chairman and CEO of Kintor Pharmaceutical, said, “the number of people suffering from alopecia is large and increasing year by year, while the therapeutic drugs available for treating alopecia are limited, and thus, clinically, there is an urgent need for safer and more effective drugs to address the problem for the people suffering from alopecia. Pyrilutamide’s phase I clinical trials conducted in the PRC and the United States, respectively, have initially verified the sound safety and tolerability of the multiple topical administrations. We will accelerate the progress of its phase II/III clinical study so as to bring benefits to the people suffering from alopecia as soon as possible.”