China-based Ascletis Pharma Inc., (HKG: 1672) has revealed revenues of RMB 46.51 million (USD 6.38 million) for the first half of 2023, marking a 21.7% increase year-on-year. The significant growth was primarily driven by Ritonavir, which contributed RMB 44.17 million, representing a substantial 6291.8% YOY increase.
Ritonavir’s Impact and Pfizer Partnership
Ritonavir, originally developed by AbbVie for the treatment of HIV/AIDS, saw Ascletis earn the first marketing approval for its generic version in China in September 2021. The company has since secured a deal with US pharmaceutical giant Pfizer to supply the drug for Pfizer’s COVID-19 therapy, Paxlovid. The strong demand for Ritonavir has contributed to an 81.2% reduction in losses during the period, amounting to RMB 16.6 million.
Progress in Antiviral Pipelines
Ascletis’s antiviral pipelines are advancing, with its chronic hepatitis B virus (HBV) therapy, ASC22, expected to reveal topline interim results of Phase IIb expansion cohort as a functional HBV cure in the third quarter of 2023. The respiratory syncytial virus (RSV) therapy, ASC10, is progressing in Phase IIa studies in China and the US, with late-stage clinical studies for ASC10 and ASC11 set to commence later this year or early next year. The Phase IIb top-line clinical results for ASC40, a treatment for non-alcoholic steatohepatitis (NASH), will be announced in the first quarter of 2024.
Upcoming Clinical Milestones
The Phase III clinical trial for the treatment of glioblastoma is on track to be completed in the third quarter of 2023, with all patients to be enrolled. The Phase III clinical trial for the treatment of acne is set to initiate soon. The interim results of the THR β agonist, ASC41, in NASH will be announced in the fourth quarter of 2023. ASC42, for the treatment of primary biliary cholangitis (PBC), is expected to yield Phase II topline data for 98 patients treated for 12 weeks by the end of the year.
Termination of ASC09 Development
Additionally, Ascletis has decided to terminate the development of ASC09, an HIV drug candidate licensed from Janssen, due to a lack of competitive edge compared to approved alternatives in China.-Fineline Info & Tech
