China-based Ascletis Pharma Inc. (HKG: 1672) has announced that its wholly-owned subsidiary Ascletis Pharmaceuticals Co., Ltd has entered into a supply agreement for ritonavir tablets with Hainan Simcere Pharmaceutical Co., Ltd, a subsidiary of Simcere Pharmaceutical Group Limited (HKG: 2096). This partnership aims to support the development and supply chain for Simcere’s SIM0417, an oral COVID-19 drug candidate co-developed with the Chinese Academy of Science’s Shanghai Institute of Materia Medica (SIMM) and the Wuhan Institute of Virology. SIM0417 was accepted for marketing review yesterday and is expected to become China’s first home-grown small molecule COVID-19 drug.
Ritonavir: Pharmacokinetic Booster
Ritonavir is a pharmacokinetic booster used in 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. In April of last 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. Additionally, Ascletis agreed in October to supply ritonavir for Pfizer’s COVID-19 therapy Paxlovid (nirmatrelvir, ritonavir).
Future Outlook
With this supply agreement, Ascletis is poised to play a crucial role in the development and commercialization of SIM0417. The collaboration underscores Ascletis’ commitment to supporting innovative COVID-19 treatments and highlights the potential of ritonavir as a key component in next-generation antiviral therapies.-Fineline Info & Tech
