Ascletis is an innovative R&D driven biotech and listed on Hong Kong Stock Exchange (1672.HK). Ascletis is committed to developing and commercializing innovative drugs in the areas of viral hepatitis, NASH and HIV/AIDS for unmet medical needs in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization.
Ascletis has three marketed products and thirteen R&D pipeline drug candidates or combination therapies (nine of them developed in-house). 1. Viral hepatitis: (i) Hepatitis B: focus on breakthrough therapies for HBV clinical cure with subcutaneously injected PD-L1 antibody - ASC22 and Pegasys® as cornerstone drugs. (ii) Hepatitis C: successfully launched all oral regimen of ASCLEVIR® and GANOVO® combination (RDV/DNV regimen); and ASC18 fixed dose combination (FDC) is an upgraded version of RDV/DNV regimen with bridging study finished. 2. NASH: Gannex, a wholly-owned company of Ascletis，is fully dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex has three clinical stage drug candidates against three different targets – FASN, THR-beta and FXR, and three pre-clinical stage combination therapies. 3. HIV/AIDS: ASC09F is a FDC treatment of HIV targeting protease. The clinical trial application of ASC09F has been approved.
We have built a commercialization team covering five major functions, including medical affairs, sales, marketing strategy, market access, and channel/distribution(GSP). The majority of our commercialization team members have extensive experience working in leading multi-national pharmaceutical companies like Roche, BMS, GSK, Merck and Novartis in China.
Our manufacturing facility located in Shaoxing, Zhejiang province with a total gross floor area of 17,000 square meters. This facility consists of API and formulation production lines, with a designed annual production capacity of 130 million tablets. We have obtained the drug production license for our manufacturing facility and passed GMP inspections by NMPA.
We believe that our integrated platform led by our experienced senior management team will expand our business and deliver sustainable growth in the future. Our platform has enabled us to become a partner-of-choice in China for global leading pharmaceutical companies, as demonstrated by the R&D and commercial collaborations with global pharmaceutical companies such as Roche.