The board of directors of the Jiangsu Recbio Technology Co., Ltd. announced that, the Group has recently received a notice of acceptance from the National Medical Products Administration to accept the application for a clinical trial of in-housed developed novel adjuvanted recombinant quadruvalent HPV vaccine, REC604a ("REC604a"). The REC604a is equipped with the novel adjuvanted BFA04 independently developed by the Company, which aims to reduce the dose of vaccination by enhancing the immunogenicity and cross-protection effects. Reducing dose number helps save costs and increase vaccination rates, which is recommended by regulatory agencies such as the WHO.

Preclinical studies have shown that the BFA04 adjuvant enhances the neutralizing antibodies by 7.7 times when compared with using an aluminum adjuvant. Compared with three-shot of HPV vaccine Gardasil ("Gardasil"), the levels of HPV neutralizing antibodies induced by two-shot of REC604a were higher than those induced by three-shot of Gardasil. In 24 weeks after the last immunization procedure, the decreasing trend of neutralizing antibody titer induced by REC604a was slower than that induced by Gardasil.

The notice of acceptance of the clinical trial for REC604a further indicates the Company's leading strength in the field of novel adjuvanted vaccines, enhances the Company's core competitiveness and market position, and is expected to provide a better prevention option for accelerating the increase of HPV vaccination rate in China. In accordance with Article 32 of the Administrative Licensing Law of the People's Republic of China, it is decided to accept it upon examination. Within 60 days from the date of acceptance, if no negative or questioning opinion is received from the Center for Drug Evaluation, the Company may carry out clinical trials in accordance with the submitted plan.