On June 8, 2018, the NDA approval for danoprevir was granted by the CFDA and we have begun to commercialize Ganovo®(danoprevir) in China.
Ganovo® is an NS3/4A protease inhibitor, which, when administered in combination with pegylated interferon and ribavirin (Ganovo Regimen), demonstrates a 97% cure rate (SVR12) and superior safety profile with a short treatment duration of 12 weeks. The current primary regimen of pegylated interferon and ribavirin in China has a cure rate of approximately 60% (SVR24) with a treatment duration of 48 to 72 weeks.
Current Therapies and Limitations
The current primary regimen for chronic HCV patients in China is weekly injections of pegylated interferon and daily oral doses of ribavirin. This regimen has the following limitations:
• Low cure rates. Only approximately 60% (SVR24) of the treated patients were cured after the treatment.
• Lengthy treatment duration. The current primary regimen requires a total of 48 to 72 weeks of treatment for HCV genotype 1. We believe that a significantly shorter duration of treatment would be preferred by patients and improve compliance with the treatment.
• Considerable side effects and poor tolerability. The current primary regimen is associated with considerable adverse effects, especially after the three-month treatment duration, such as psychosis, abnormal thyroid function, depression, fatigue, “flu-like” symptoms and hemolytic anemia. A study has shown that approximately 22% of patients discontinued during the treatment period of a current primary regimen of 48 weeks.
Advantages of Ganovo®
We believe that Ganovo Regimen has the following advantages:
• Higher cure rate. Ganovo Regimen demonstrated a 97% cure rate (SVR12) in a phase III clinical trial completed on 140 HCV patients, which is substantially higher than the current primary regimen in China. The following diagram sets forth the virologic response (including RVR4, RVR8, EOT and SVR12) from our phase III clinical trial.
• Shorter treatment duration. The 12-week Ganovo Regimen is significantly shorter than the 48 to 72 weeks treatment duration of the current primary regimen. We believe that shorter regimens will increase compliance to the treatment and improve patient tolerability.The following diagram sets forth the virologic response (including RVR4, RVR8, EOT and SVR12) from our phase III clinical trial.
• Superior safety and tolerability profile. No grade 3 or higher laboratory liver function abnormalties were observed in our phase III clinical trial of the Ganovo Regimen. Moreover, there was no discontinuation of use due to adverse events. The rate of serious adverse events potentially related to the use of Ganovo Regimen was approximately 0.7%.
• Potent anti-viral activity. Ganovo® demonstrated potent activity against HCV NS3/4A protease derived from HCV genotypes 1 through 6 with sub-nanomolar to nanomolar potencies. In clinical trials, our Ganovo Regimen has shown an overall cure rate over 97% (SVR12) against HCV genotype 1 and 4 infections.
•Efficacy in cirrhotic patients. Clinical trials have demonstrated that Ganovo Regimen had a 91% cure rate (SVR12) in cirrhotic patients in Taiwan.
• High genetic barrier to resistance. No pre-treatment genetic resistance testing is required for Ganovo®based on clinical trial results and expert consensus due to its high genetic barrier to resistance. In the phase III clinical trial, no virological breakthrough (on-treatment failure) occurred in patients receiving treatment.