China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that its oral nucleoside analog drug JT001 (VV116) for treating COVID-19 has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development and potential market approval of the drug in China.
Development and Clinical Trials
JT001 (VV116) was co-developed by the Shanghai Institute of Materia Medica (SIMM), the Wuhan Institute of Virology, and other research institutes. In October 2021, Junshi established a joint venture with Vigonvita Life Sciences Co., Ltd, a specialist in neuropsychiatric and infectious diseases, to develop JT001. The JV, Shanghai JunTop Biosciences Co., Ltd, secured emergency use approval for the drug in Uzbekistan in December 2021 following a clinical trial in that country.
Clinical Data and Future Outlook
VV116 is a deuterated remdesivir hydrobromide with oral bioavailability and potent activity against SARS-CoV-2, as demonstrated in animal studies. It also showed satisfactory safety and side-effect profiles in Phase I trials. In May 2022, a Phase III clinical study comparing VV116 with Pfizer’s Paxlovid reached the primary endpoint of non-inferiority. Additionally, a Phase III study for VV116 in mild to moderate COVID-19, with or without a high risk of severe progression, commenced in October. These developments position Junshi Biosciences to potentially offer a new treatment option for COVID-19.-Fineline Info & Tech
