Incidents:
The company announced that the first-of-its-kind clinical trial of ASC40 (Denifanstat), an oral fatty acid synthase (FASN) inhibitor, ASC40 (Denifanstat), treated acne phase II once a day, reached the main and critical secondary end points.
Comments and opinions:
Excellent clinical efficacy and good safety:
ASC40 is an oral, selective small molecule FASN inhibitor. The mechanism of ASC40 in treating acne is: (1) directly inhibits facial sebum production by inhibiting fatty acid synthesis (DNL) in human sebaceous cells from scratch; and (2) inhibits inflammation by reducing cytokine secretion and Th17 differentiation. The 25 mg group reduced total skin damage by 53.1%, the 50 mg group reduced 61.3%, the 75 mg group reduced 53.1%, and placebo reduced 34.2%. The efficacy was accurate and statistically significant. Good safety. Based on excellent phase II data, the company is rushing to conduct phase III clinical trials. Acne is the 8th most common disease in the world, affecting more than 640 million people worldwide. Currently, there is no effective treatment, and there is a broad market space for ASC40.
Multi-pipeline research and development is progressing smoothly:
The company focuses on key pipeline development, including 6 phase II or phase III clinical pipelines in multiple acne/hepatitis B/NASH/glioma/RSV disease areas. Among them, ASC40 (acne) phase II data is excellent. ASC40 (FASN) treatment was confirmed by biopsy after biopsy to confirm that NASH patients had phase IIb clinical analysis during the 2022 American Liver Release Period. At the same time, ASC40 (glioma) also completed the enrollment of 80% of patients with stage III clinical trials. ASC22 (PD-L1) has achieved a negative surface antigen conversion rate of 42.9% in the current IIb expansion cohort progression, which has significant advantages over other drugs under development for the functional cure of hepatitis B. The company has global interests in ASC41 NASH and has multiple layers of patent protection, and has now completed the first patient administration of phase II clinical trials. ASC10 has submitted a phase IIa clinical trial application for the treatment of respiratory syncytial virus infection. The company will also actively explore international BD project cooperation, which is expected to achieve results this year.
The company's positioning is clear and the market space is broad
ASC40 treatment for acne has certain consumer medical properties, and the company prefers to cooperate with strong partners in this field, and does not rule out building its own team to sell it. The company has a cash reserve of 2.47 billion yuan, which is enough to guarantee R&D investment needs for more than 5 years. The margin of safety is very high. The company will speed up the development of phase III clinical trials. The acne market space is broad, and the company's product treatment data is excellent. The company will focus on non-alcoholic steatohepatitis, moderate to severe acne, and functional treatment of hepatitis B, etc., and research and development is progressing smoothly. Active attention is recommended.