We are a fully integrated anti-viral platform focusing on developing and commercializing innovative, best-in-class drugs against HCV, HIV and HBV. Led by a management team with deep expertise and a proven track record, we have developed an integrated anti-viral platform covering the entire value chain from discovery and development to manufacturing and commercialization.
We currently have five anti-viral drug discovery and development programs. In our HCV portfolio, we have three HCV drug candidates, including Ganovo® , which has been approved and launched successfully, and ravidasvir, which NDA has been accepted, against three validated targets. Our HIV drug candidate (ASC09) has completed a phase IIa clinical trial.
Ganovo® (danoprevir) is the first HCV cure near commercial-stage developed by a domestic company in China. Ganovo® is a direct-acting anti-viral agent (“DAA”) and NS3/4A protease inhibitor, which, when administered in combination with pegylated interferon and ribavirin (“Ganovo Regimen”) demonstrated a far higher cure rate of 97% 1(SVR12), a shorter treatment duration of 12 weeks and a superior safety and tolerability profile.
We believe ravidasvir is a best-in-class, pan-genotypic DAA targeting the HCV NS5A protein. Ravidasvir, when administered in combination with Ganovo® and ribavirin, forms an all-oral, interferon-free HCV therapy (“RDV/DNV Regimen”). Our RDV/DNV Regimen is the first all-oral, interferon-free, phase III-completed HCV regimen developed by a domestic company in China. RDV/DNV Regimen offers a 99%2 cure rate (SVR12), a short treatment duration of 12 weeks, a superior safety profile and a 100%2 cure rate (SVR12) for patients with baseline NS5A resistance mutations, all of which differentiate this regimen from products of our competitors. With both RDV/DNV Regimen and Ganovo Regimen, we have demonstrated our commitment and ability to provide multiple advanced treatment options to a vast number of HCV patients in China.
We have a strong track record and high success rate in developing products. We have three HCV drug candidates against three validated targets, of which we have advanced two to phase III completion. Such high success rate is, we believe, a reflection of the capabilities and efforts of our research and development team. Our research and development team is led by senior scientists from global pharmaceutical companies, such as GSK and Roche. In preparation for the commercialization of Ganovo® and ravidasvir, we have spent two years building a commercialization team of approximately 145 members covering four major functions, including sales, marketing strategy, market access/reimbursement and channel/distribution. In anticipation of the commercialization of our drug candidates, we have built a manufacturing facility with an annual production capacity of 130 million tablets.
1、 Wei L. et al.Danoprevir regimen efficacy in genotype 1 CHC. Journal of Clinical and Translational Hepatology 2019 vol. 7 | 1–5
2、 Xu X. et al.Efficacy of RDV + DNV regimen in GT1 CHC patients. Journal of Clinical and Translational Hepatology 2019 vol. 7 | 1–8