Kangle Weishi Halts Phase III Clinical Trials of Bivalent and Nonavalent HPV Vaccines Due to Overdue Clinical Funding Payments

On January 15, Health Guard announced that it had recently received letters from the Shanxi Provincial Center for Disease Control and Prevention and the Jiangsu Provincial Center for Disease Control and Prevention.

According to the letter, due to overdue payments for clinical trial expenses by Health Guard and a shortage of on-site research funds, subsequent gynecological follow-up visits cannot be continued.

Therefore, the Shanxi Provincial Center for Disease Control and Prevention has suspended the Company’s Phase III clinical trials of its trivalent HPV vaccine and nonavalent HPV vaccine, and the Jiangsu Provincial Center for Disease Control and Prevention has suspended the Company’s Phase III clinical trial of its nonavalent HPV vaccine.

Health Guard stated that the Phase III clinical trial of its trivalent HPV vaccine met the pathological endpoint (CIN2+) collection requirements specified in the clinical protocol and formed an interim analysis report in August 2024. Currently, the project is conducting 48- to 60-month follow-up visits and continues to accumulate CIN2+ cases. Given that the Phase III clinical trial of the trivalent HPV vaccine has fulfilled the case collection requirements for the clinical endpoints and its marketing authorization application was accepted in April 2025, the suspension of the clinical trial will not affect the eligible cases and related results already accumulated. Therefore, it is expected that this suspension will not have a significant adverse impact on the company’s marketing authorization application for the trivalent HPV vaccine.

Furthermore, the Phase III clinical trial of Health Guard’s 9-valent HPV vaccine (female indication) met the protocol-specified requirements for collecting data on the primary virological endpoint (PI12) in February 2025, and an interim analysis report was generated. Currently, the project is conducting visits at months 48 to 54 and continues to accumulate cases for the secondary endpoints outlined in the clinical protocol, such as CIN2+. Although case collection for the primary endpoints of the 9-valent HPV vaccine (female indication) has been completed per the clinical protocol, a prolonged failure to resume normal clinical trial operations may adversely affect the collection of cases for secondary endpoints and the submission of the marketing application.