Ascletis announce signing license and supply agreement of ritonavir for COVID-19 drug PAXLOVID™ in mainland China With Pfizer
Under the Agreement, Ascletis will grant Pfizer China a non-exclusive right to utilize certain of Ascletis’ regulatory data with respect to ritonavir tablets for COVID-19 drug PAXLOVID™, and manufacture and supply ritonavir tablets to Pfizer China, in mainland China.
Oct 28, 2022 - - Ascletis Pharmaceuticals Co., Ltd. announced today that it has entered into a license and supply agreement of ritonavir 100 mg Film Coated Tablet with Pfizer Investment Co., Ltd., pursuant to which the Company will grant Pfizer China a non-exclusive right to utilize certain of Ascletis’ regulatory data with respect to ritonavir tablets for PAXLOVID™, an oral drug for COVID-19, and manufacture and supply the Product to Pfizer China, for patients in mainland China. The term of the Agreement is 5 years commencing from the date of the Agreement. The actual amount of the Product supply to Pfizer China is dependent on actual purchase orders placed by Pfizer China over the Agreement period.
PAXLOVID™ is a small-molecular oral COVID-19 therapeutic drug, which is used to treat adult patients with mild to moderate New Coronavirus pneumonia (COVID-19) who are at risk of disease progression such as elderly (patients who are above 60) or patients with one or more risk factors such as chronic kidney disease, diabetes, cardiovascular disease and chronic lung disease. On February 11th 2022, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) received conditional approval under Special Review Process from National Medical Products Administration, China (“China NMPA”). Pfizer COVID-19 medicine, PAXLOVID™ is currently approved or authorized for conditional or emergency use in approximately 70 markets.
Ritonavir tablet is a pharmacokinetic booster of multiple oral antiviral drugs targeting viral proteases. Ascletis currently owns the only authorized ritonavir tablet manufactured in China, which has passed bioequivalence study. Ascletis’ ritonavir tablet was approved in September 2021 by China NMPA (H20213698).
About Pfizer:
Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. For more information, please visit www.pfizer.com.cn.
About Ascletis
Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has three marketed products, i.e. ritonavir tablets, GANOVO® and ASCLEVIR®, and 20 drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (HBV functional cure), ASC10 and ASC11(oral small molecules for COVID-19 treatment), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis), and ASC40 (acne).
For more information, please visit www.ascletis.com.
Source: www.ascletis.com
