Junshi Biosciences’ (HKG: 1877, SHA: 688180) COVID-19 therapy JT001 (VV116) appears to be facing supply issues, prompting the company to seek additional production and supply agreements. The latest deal was struck with Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460), following a similar agreement with Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) just days earlier. No financial details were disclosed.
Production and Supply Agreement
The agreement with Sihuan Pharma will see the company provide process optimization, quality method transfer, pilot scale-up, processing, and commission regulatory filing services for JT001 (VV116). This oral nucleoside analog drug for COVID-19 has been a focus of Junshi Biosciences’ efforts to address the ongoing pandemic.
Development and Regulatory Milestones
JT001 (VV116) was co-developed by the Shanghai Institute of Materia Medica (SIMM), Wuhan Institute of Virology, and other research institutes. In October 2021, Junshi established a joint venture with Vigonvita Life Sciences Co., Ltd, a neuropsychiatric and infectious diseases specialist incubated by SIMM in Suzhou. The JV, Shanghai JunTop Biosciences Co., Ltd, is responsible for JT001’s development and secured an emergency use approval for the drug in Uzbekistan in December 2021 after conducting a clinical trial in that country.
Partnership with Zhejiang Hisun Pharmaceutical
In May last year, Zhejiang Hisun Pharmaceutical Co., Ltd (SHA: 600267) signed a five-year partnership with the JV. Under this agreement, Hisun will provide product processing, manufacturing, and support on international regulatory filings and market development. Most recently, the drug obtained conditional approval in China in late January this year to treat mild to moderate COVID-19 cases.-Fineline Info & Tech
