China’s Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) has entered into a partnership with WuXi STA, a subsidiary of WuXi AppTec, for the commercial supply of ziresovir, a novel treatment for respiratory syncytial virus (RSV) infections.
Ziresovir: A First-in-Class RSV Fusion Inhibitor
Ziresovir, a first-in-class small molecule RSV fusion (F) protein inhibitor, has made history as the first oral RSV antiviral drug to successfully complete Phase III clinical trials on a global scale. The New Drug Application (NDA) for ziresovir has been accepted and granted Priority Review by the China National Medical Products Administration (NMPA), positioning it as potentially the world’s first-approved anti-RSV therapeutic drug.
WuXi STA’s Role in Ziresovir’s Development and Supply
As a long-term partner of ArkBio, WuXi STA has provided customized formulation R&D and manufacturing services for ziresovir throughout its development process. In the first quarter of 2023, WuXi STA’s Waigaoqiao site successfully passed the NMPA’s Pre-Approval Inspection (PAI) for ziresovir, which is a significant step towards its upcoming NDA approval in China.
Strengthening Collaboration in R&D and Manufacturing
According to the agreement between ArkBio and WuXi STA, both companies will continue to strengthen their collaboration in various aspects, from customized formulation R&D to commercial manufacturing. This partnership is set to ensure the smooth development and supply of ziresovir, contributing to the global fight against RSV infections.-Fineline Info & Tech
