Goli Pharmaceutical-B (01672): Application for marketing of the first FASN inhibitor denifastat (ASC40) to treat acne was accepted by the State Drug Administration

Zhitong Finance App News, Goli Pharmaceutical-B (01672) issued an announcement. The board of directors announced that the first-in-class (first-in-class) new drug marketing application (NDA) for treating severe acne vulgaris (ASC40), the first-in-class (FASN) inhibitor, once a day has been accepted by China's State Drug Administration.

“The acceptance of this NDA is an important milestone on our path to providing potentially pioneering treatments for moderate to severe acne.” Dr. Wu Jinzi, founder, chairman of the board of directors and CEO of Goli, said, “We are thrilled that dinifastat (ASC40) is only one step away from commercialization.”

Curie has completed phase II (NCT05104125) and phase III (NCT06192264) studies on treating severe acne vulgaris with denifastat (ASC40).

In this phase III study, denifastat (ASC40) reached all primary, critical secondary, and secondary efficacy endpoints (Intent Treatment Set (ITT) analysis), significantly improving moderate to severe acne vulgaris compared to placebo. Denifastat (ASC40) has shown good safety and tolerability characteristics. All treatment-emergent adverse events (TEAE) associated with dinifastat (ASC40) during treatment were mild (grade 1) or moderate (grade 2). There were no grade 3 or 4 TEAE associated with denifastat (ASC40), and no serious adverse events (SAE) associated with denifastat (ASC40). No cases of permanent termination of treatment or withdrawal trials associated with denifastat (ASC40) have been observed.

On September 17, 2025, at the 2025 European Society of Dermatology and Venereology (EADV) Annual Meeting held in Paris, France, Geli orally presented the results of the Phase III study.

The company has recently completed pre-marketing (pre-NDA) communication with the China National Drug Administration on denifanstat (ASC40) for the treatment of severe acne vulgaris (pre-NDA) and has received positive feedback from the China Drug Administration.

Clarion has obtained an exclusive license for dinifastat (ASC40) from Sagimet Biosciences Inc. (NASDAQ: SGMT) in Greater China.