China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) announced that a clinical trial filing for its in-house developed neoadjuvant recombinant tetravalent human papillomavirus (HPV) vaccine has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of Recbio’s vaccine portfolio.
REC604a: Vaccine Profile and Preclinical Results
REC604a, which carries the neoadjuvant BFA04 independently developed by Recbio, is designed to reduce the number of injections required for immunization by enhancing immunogenicity and cross-protection. Preclinical studies have shown that the BFA04 adjuvant can increase neutralizing antibodies by 7.7 times compared to aluminum adjuvants. When compared to Merck Sharp & Dohme’s tetravalent HPV vaccine Gardasil, which requires three doses, two doses of REC604a induced higher levels of HPV neutralizing antibodies. By the 24th week after the last injection, the titer of neutralizing antibodies produced by REC604a decreased more slowly than that of Gardasil.
Market Context and Future Outlook
Currently, no domestic 9-valent HPV vaccine has been approved for sale in China. The market is served by GSK’s Cervarix (bivalent HPV adsorbed vaccine), MSD’s Gardasil4 and Gardasil9, Wantai Bio’s Cecolin (bivalent HPV adsorbed vaccine), and Walvax Bio’s bivalent HPV adsorbed vaccine. Meanwhile, Recbio’s REC603, a 9-valent HPV vaccine, is undergoing clinical trials in China. With the acceptance of REC604a for review by the NMPA, Recbio is poised to further expand its presence in the HPV vaccine market.-Fineline Info & Tech
