Recently, Beijing Health Guard Biotechnology, Inc. (hereinafter, BHGB) received the DSMB’s (Data and Safety Monitoring Board) Recommendation with respect to the first primary endpoint analysis in the Phase III clinical trial in Indonesia of its in-house developed recombinant Nonavalent HPV Vaccine, which is made based on the data readout from the analysis. As indicated in the Recommendation letter, the review by the DSMB of available safety and immunogenicity data, as well as quality of the study finds that the investigational vaccine has an acceptable safety profile and the trial meets the pre-specified primary immunogenicity endpoint; therefore, the DSMB recommends the study proceed as per the current study protocol.

BHGB’s Nonavalent HPV Vaccine is designed to target seven high-risk types, i.e., HPV 16/18/31/33/45/52/58, and two low-risk types, i.e., HPV 6/11. It is mainly intended for the prevention of HPV 16/18/31/33/45/52/58-related cancers, such as cervical cancer, and genital warts caused by HPV 6/11 infection. The Company is advancing two Phase III clinical efficacy trials with the Nonavalent HPV Vaccine in China, one in females and one in males, and launched a Phase III clinical trial of the Nonavalent HPV Vaccine in Indonesia in November 2023 after obtaining clinical trial approval from the Indonesian BPOM for the trial in September that year.

The Phase III clinical trial in Indonesia adopted a randomized and blinded design, with Gardasil® 9 as the positive control. A total of 1,260 subjects were enrolled and each will complete 14 follow-up visits. Blood samples for immunogenicity evaluation will be collected prior to the first dose, and Month 7, 12, 18, and 24 post the first dose. The primary objective of the study is to evaluate whether the immune responses (specifically, neutralizing antibody levels) elicited in healthy women aged 18 to 45 years receiving a 3-dose schedule of the investigational vaccine are non-inferior to those induced by MSD’s nonavalent HPV Vaccine Gardasil® 9.

As of now, subjects in the Phase III clinical trial of the Nonavalent HPV Vaccine in Indonesia have completed safety follow-ups and blood sample collections for 6 months after full vaccination (i.e. 12 months after the first dose), and testing of blood samples collected will commence soon. The first primary endpoint analysis was conducted mainly on the safety data collected up to November 26, 2024, and immunogenicity data for samples collected one month after full vaccination (i.e., Month 7 post the first dose).

After the data readout from the first primary endpoint analysis, the parties involved in the Phase III clinical trial of the Nonavalent HPV Vaccine in Indonesia will need to conduct further comprehensive and in-depth analyses in accordance with the trial protocol and statistical analysis plan, and compile a clinical study report therefor. The Company will submit a Marketing Authorization Application (MAA) for the Nonavalent HPV Vaccine to the Indonesian BPOM as per the requirements of applicable Indonesian regulations.

The positive data readout from the first primary endpoint analysis in the Phase III clinical trial of the Nonavalent HPV Vaccine in Indonesia is a significant milestone for the clinical development of the Company’s Nonavalent HPV Vaccine, which lays a solid foundation for the Company to submit an MAA in Indonesia and other countries as the case may be.