Suzhou, September 8, 2021 - Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX:9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced the primary endpoint of phase II clinical trial of pyrilutamide ("KX-826", tincture) in China for the treatment of androgenetic alopecia (AGA) was met, which was statistically significant and clinically meaningful.

The phase II clinical trial was a multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of KX-826 for the treatment of male AGA adults (N=120). The primary endpoint for the trial was the change from baseline in non-vellus target area hair counts (TAHC) at week 24 in comparison with placebo.

The majority of adverse events (AEs) were mild and no serious adverse event (SAE) was reported. KX-826 was well-tolerated and no new safety signals were observed. Detailed data will be released later upon the finalization of the clinical study report. 5mg (0.5%) KX-826 was determined as the dose to be taken into phase III clinical trial in China, which we expect to kick off the work in Q4 2021.

Dr. Youzhi Tong, Founder, Chairman, and CEO of Kintor Pharma, commented, “We are delighted to see the primary endpoint in KX-826’s phase II study for AGA was met. Hundreds of millions of people around the world are troubled with AGA, accounting for approximately 90% of patients with hair loss. There is an urgent need for a safer and more effective drug to address this problem. We are conducting phase II clinical trial of KX-826 for the treatment of male AGA patients in the US and will accelerate the progress of phase III clinical trial of KX-826 for the treatment of male AGA patients in China. We also target to conduct phase II clinical trial for female AGA patients in China, so as to bring benefits to the people suffering from AGA around the globe as soon as possible.”