HANGZHOU and SHAOXING, China, Aug. 5, 2019 /PRNewswire/ -- Ascletis Pharma Inc. (1672.HK), an innovative R&D driven, commercial-stage biotechnology company addressing unmet medical needs in therapeutic areas including anti-viral, cancer and fatty liver diseases, announces today that it received IND approval of ASC18, first one-pill, once-a-day fixed dose combination (FDC) as the complete hepatitis C treatment developed by a Chinese biotech, from National Medical Products Administration (NMPA).
In March 2019, Ascletis received IND approval of ASC21, HCV NS5B nucleotide polymerase inhibitor from NMPA. In addition to two IND approvals above, Ascletis' HCV portfolio consists of Ganovo® (Danoprevir), that has been commercialized since June 2018 and Ravidasvir, its NDA was accepted in August and designed as priority review in October 2018 by NMPA.
"Ascletis is on track to deliver 2019 R&D milestones," said Jinzi J. Wu, PhD, Founder, Chairman and CEO. "We would like to re-emphasize that the Company's fundamentals are strong and unchanged. The management team is confident on achieving the Company's 2019 objectives of R&D, reimbursement and in-licensing clinical and commercial stage assets while continuing to improve the Company's financial performance. The management team also remains an optimistic view on the Company outlook for 2020 and going forward."
Dr. Wu continues, "As an innovative R&D driven biotech with two commercial products (Ganovo® and Pegasys®), we have successfully attracted talents from multi-national companies in all key functions of the Company's business. As the Company has successfully retained and developed many of these talents, we are continuing to attract high-level talents, especially in R&D and commercialization, from multi-national companies and biotechs on a global basis."
About Ascletis
Ascletis is an innovative R&D driven biotech with two commercial products and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis' mission is to address unmet medical needs in three therapeutic areas: viral, cancer and fatty liver diseases. Led by a management team with deep expertise and a proven track record, Ascletis has developed a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is now commercializing two drugs, Ganovo® (Danoprevir), the first direct-acting anti-viral agent for hepatitis C developed domestically for China, and Pegasys® (Peginterferon alfa-2a), a well-established pegylated interferon for hepatitis B&C partnered with Roche. Ascletis' R&D pipeline consists of antibody-based immunotherapy, first/best-in-class small molecules and siRNA at various clinical development stages. For more information, please visit www.ascletis.com.