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HANGZHOU and SHAOXING, China, August 4, 2019 / PRNewswire / – Ascletis Pharma Inc. (1672.HK), an innovative R & D and commercial biotechnology company that addresses unmet medical needs in therapeutic areas such as antiviral diseases, cancer and steatosis hepatic, received today the approval of the IND of AUC18, first fixed-dose combination to be taken once a day (FDC) in the form of a treatment Comprehensive against hepatitis C developed by a Chinese biotechnology company, the National Medical Products Administration (NMPA).
In March 2019Ascletis has received approval from the IND of NMPA, ASC21, an HCV NS5B HCV nucleotide polymerase inhibitor. In addition to the two IND approvals mentioned above, the HCV portfolio of Ascletis includes Ganovo® (Danoprevir), marketed since June 2018 and Ravidasvir, his NDA was accepted in August and designed as a priority review in October 2018 by NMPA.
"Ascletis is on track to reach the milestones of R & D for 2019," said Jinzi J. Wu, PhD, founder, chief executive officer. "We would like to re-emphasize that the fundamentals of the company are strong and unchanged." The management team is confident that the Company's 2019 R & D objectives will be met. reimbursement and licensing of clinical and commercial badets, while continuing to improve the financial performance of the company.The management team also remains optimistic about the prospects of the company for 2020 and the following. "
Dr. Wu continues: "As an innovative biotechnology focused on R & D with two commercial products (Ganovo® and Pegasys®), we have successfully attracted the talents of multinational companies in all the key functions of the company's activities. As the company has retained and developed many of these talents, we continue to attract high-level talent, particularly in the areas of research and development and commercialization, multinational companies and companies. biotechnologies on a global scale. "
About Ascletis
Ascletis is an innovative biotechnology focused on R & D that offers two commercial products and is listed on the Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis' mission is to address unmet medical needs in three therapeutic areas: viral diseases, cancer and hepatic steatosis. Led by a management team with deep expertise and proven experience, Ascletis has developed a fully integrated platform spanning the entire value chain, from discovery and development to manufacturing and marketing. Ascletis currently markets two drugs, Ganovo® (Danoprevir), the first nationally developed direct-acting anti-viral agent for hepatitis C for Chinaand Pegasys® (Peginterferon alfa-2a), a well-established pegylated interferon for hepatitis B & C, in partnership with Roche. Ascletis' research and development pipeline includes antibody immunotherapy, first-order, first-choice small molecules and siRNA at various stages of clinical development. For more information, visit www.ascletis.com.
SOURCE Ascletis Pharma Inc.
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