Junshi Bio’s new crown oral drug phase III clinical trial reaches the primary endpoint and will communicate and submit the listing application jqknews

May 24,Junshi BiologyreleaseannouncementAccording to the statement, the oral nucleoside anti-SARSCoV-2 drug VV116 tablets (referred to as “VV116”) jointly developed by its holding subsidiary Juntuo Biology and Suzhou Wangshan Wangshui Biomedicine Co., Ltd. A Phase III registration clinical study (NCT05341609) comparing nermatvir tablet/ritonavir tablet (ie PAXLOVID) for the early treatment of mild to moderate novel coronavirus pneumonia (“COVID-19”) reached the preset protocol the primary endpoint. The company will communicate with the regulatory authorities in the near future to submit the new drug marketing application.

The NCT05341609 study is a multi-center, single-blind, randomized, controlled phase III clinical study to evaluate VV116 versus Nematevir/Ritonavir (PAXLOVID) for the early treatment of patients with mild to moderate COVID-19 effectiveness and safety. The study was conducted by Academician Ning Guang of Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine as the principal investigator, and 822 patients were actually enrolled. Percentage of subjects with COVID-19 progression (defined as progression to severe/critical COVID-19 or death from all causes)” et al. The results of this clinical study showed that VV116 for the early treatment of mild to moderate COVID-19 achieved the primary endpoint pre-specified in the clinical program.

In September 2021, Juntuo Biology and Wangshan Wangshui entered into a cooperative developmentcontract, jointly undertake the clinical development and industrialization of VV116 in the cooperation area, and the cooperation area is global except for the five Central Asian countries, Russia, North Africa and the Middle East. VV116 showed good safety, tolerability and pharmacokinetic properties in healthy subjects, and the results of three related phase I clinical studies have been published online in Acta Pharmacologica Sinica, a well-known journal in the field of pharmacy. Currently, VV116 is in the In the phase III clinical research phase of the international multi-center, a number of clinical studies for patients with mild to moderate and moderate to severe COVID-19 are in progress.

(Article source: Beijing News)

Article source: Beijing News

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Original title: Junshi Bio’s new crown oral drug phase III clinical trial reached the primary endpoint and will communicate and submit the marketing application