Ascletis Pharma Inc. (HKG: 1672) announced that its wholly-owned subsidiary Ascletis Pharmaceuticals Co., Ltd has entered into a five-year license and supply agreement with Pfizer Investment Co., Ltd, the China unit of US-based Pfizer Inc. The agreement relates to the ritonavir 100 mg film-coated tablet, a key component of Paxlovid (nirmatrelvir + ritonavir), an oral COVID-19 therapeutic drug. Under the agreement, Ascletis will grant Pfizer China a non-exclusive right to utilize certain regulatory data and to manufacture and supply the product for patients in mainland China. The actual supply volume will depend on purchase orders placed by Pfizer China over the agreement period.
Paxlovid: Target Population and Global Approvals
Paxlovid is a small-molecular oral COVID-19 therapeutic drug designed to treat adult patients with mild to moderate COVID-19 who are at risk of disease progression. This includes elderly patients (above 60) and those with risk factors such as chronic kidney disease, diabetes, cardiovascular disease, and chronic lung disease. Paxlovid was conditionally approved for marketing in China in February 2022 and has since been approved or authorized for conditional or emergency use in approximately 70 markets globally.
Ritonavir: Pharmacokinetic Booster and Market Position
Ritonavir is a pharmacokinetic booster used in combination with multiple oral antiviral drugs targeting viral proteases. Ascletis currently holds the only authorized ritonavir tablet manufactured in China, which has passed bioequivalence studies. Ascletis’ first generic ritonavir tablet was approved by the National Medical Products Administration (NMPA) in September 2021 for the treatment of HIV. The company has also filed for marketing authorization in 12 European countries through its European agent. In April of this year, China Meheco International Co., Ltd, a wholly-owned subsidiary of China Meheco Group Co., Ltd, became the distributor for ritonavir tablets in mainland China.-Fineline Info & Tech
