Suzhou, July 11, 2021 - Kintor Pharmaceutical Limited (HKEX:9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has greenlighted pyrilutamide (KX-826)’s phase II clinical trial for the treatment of androgenetic alopecia (AGA).

The US-based phase II trial is a randomized, double-blind, vehicle-controlled, parallel-group study designed to evaluate the efficacy and safety of pyrilutamide in male subjects with AGA. The primary endpoint for the trial is the change from baseline in non-vellus Target Area Hair Counts (TAHC) at Week 24 in comparison to vehicle.

Dr. Tong Youzhi, founder, Chairman, and CEO of Kintor Pharmaceutical, commented, “We are delighted to receive the FDA’s greenlight for this trial, as Kintor’s strategy is to conduct trials in both China and the US. Patient dosing of pyrilutamide’s phase II clinical trial in China for AGA has been completed, the data of which is expected to read out in the third quarter of 2021. AGA affects hundreds of millions of men and women around the world, accounting for approximately 90% of patients with hair loss. We hope to demonstrate pyrilutamide can become a treatment for patients with this condition. ”

About Pyrilutamide (KX-826)

Pyrilutamide, a topical androgen receptor (AR) antagonist with a specific target, can inhibit the combination of androgen receptor and androgen in hair follicle sebaceous glands, thereby treating androgeneticalopecia and acne.

About Kintor Pharmaceutical Limited

Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancer, alopecia, and acne. For more information, visit www.kintor.com.cn.