Core Viewpoint - The company, 康乐卫士, has announced the suspension of its Phase III clinical trials for both the trivalent and nine-valent HPV vaccines due to overdue funding and insufficient on-site research funds, as communicated by health authorities in Shanxi and Jiangsu provinces [1][2] Group 1: Clinical Trial Suspension - The trivalent HPV vaccine (16/18/58 types) and the nine-valent HPV vaccine (6/11/16/18/31/33/45/52/58 types) clinical trials have been suspended due to overdue clinical trial funding [1] - The suspension is primarily due to the inability to continue gynecological visits necessary for the trials [1] Group 2: Impact on Clinical Trials - The trivalent HPV vaccine has already met the endpoint case collection requirements for its clinical protocol and is expected to have its market approval application accepted by April 2025, indicating that the suspension will not significantly impact this project [1] - The nine-valent HPV vaccine has completed the collection of cases for its primary endpoint and is currently in the process of accumulating secondary endpoint cases, but prolonged suspension may adversely affect this aspect [2] Group 3: Funding and Future Actions - The company is actively seeking funding through various channels to resolve overdue payments and resume normal clinical trial operations [2] - There is a risk that stakeholders may terminate the project if the company fails to make timely payments for overdue funding [2]
康乐卫士三价和九价HPV疫苗临床试验暂停