China-based Ascletis Pharma Inc., (HKG: 1672) has announced significant business adjustments, including the decision to cease promoting and marketing its hepatitis C virus (HCV) products, ravidasvir and danoprevir. The decision comes in response to the HCV market’s challenges, which include the impact of the National Reimbursement Drug List (NRDL), the absence of a position for its product portfolio in the latest HCV guidelines, and a significant decrease in HCV cases and demand due to COVID-19.
Termination of Development for ASC06 and ASC09
In addition to the changes in their HCV portfolio, Ascletis has also decided to end the development of two investigational candidates, ASC06 and ASC09. ASC06, designed to treat liver cancer through RNA interference delivery technology, faced termination due to the technology becoming outdated and potentially lacking a competitive edge in the future. Despite completing Phase I clinical trials in the US, the drug has not been filed for IND in China. Ascletis plans to replace ASC06 with a small molecule programmed-death ligand 1 (PD-L1) inhibitor, ASC61.
ASC09 Development Halted Due to Market Shifts
ASC09, an HIV protease inhibitor in-licensed from Janssen in 2013, has completed Phase I clinical studies in combination with ritonavir in China. The development of ASC09 is being terminated as alternative products, such as HIV Entry inhibitor drugs with the same indications, have been approved for marketing in China and have become the mainstream choice for the treatment of HIV type 1 infection. ASC09 is seen to lack competitive advantages over these alternatives.-Fineline Info & Tech
