On 17 September 2020, Kintor Pharmaceutical Limited (stock code: 9939.HK, or “Kintor Pharma”) is pleased to announce that it has received clinical trial approval from the National Medical Products Administration for the gel dosage form of KX-826 for the treatment of acne and androgenetic alopecia.

Acne is a chronic inflammatory skin disease of the hair follicle sebaceous gland unit, which occurs mostly in puberty and mainly affects the face. According to a Frost & Sullivan report, in 2018, more than 118.9 million Chinese patients aged between 10 and 25 had acne vulgaris. From 2019, the total number of patients is expected to increase at a compound annual growth rate of 0.4% to 121.3 million in 2023, and then at a CAGR of 0.2% to 122.5 million in 2028. The pathogenesis of acne is complicated. The influence of androgen and its receptor signaling pathway on sebaceous glands and sebum secretion is one of the important factors causing acne. To date, there is no effective topical androgen inhibitor in China that can be used for the treatment of acne, and the unmet clinical demand in the market is great.

Kintor Pharmaceutical's KX-826 gel is a well-targeted topical androgen receptor (AR) antagonist. It competitively inhibits the binding of androgen in the skin tissue to the androgen receptor and can locally control the activation of the receptor signaling pathway caused by androgen hyperactivity without changing the activity of the androgen receptor signaling pathway in the human body. Through application on the affected place, the drug can inhibit the combination of androgen receptor and androgen in hair follicle sebaceous glands, thereby treating acne. In August 2020, the U.S. Food and Drug Administration approved a new drug for the treatment of acne with the same target. It is an innovative drug approved for this indication in the past 40 years, whose mechanism of action has been verified to effectively treat acne.

The clinical trial approval in China for KX-826 has further expanded Kintor Pharma’s research and development pipelines and is expected to enlarge the already massive market for acne medicine. Going forward, the Company will accelerate clinical trials for the KX-826 gel, in efforts to benefit acne patients by launching the drug as soon as possible.