RECBIO-B(02179) New adjuvant recombinant nine-valent HPV vaccine REC604c China clinical trial application accepted
12/02/2025
GMT Eight
RECBIO-B (02179) Announcement: The group has recently received a notice of acceptance issued by the National Medical Products Administration, agreeing to accept the clinical trial application for its self-developed new adjuvant recombinant nine-valent HPV vaccine REC604c.
REC604c is a new recombinant nine-valent HPV vaccine developed by the company for the male market and an upgraded market. This product is an upgrade based on the previous generation nine-valent HPV vaccine, carrying a new adjuvant with the company's independent intellectual property rights, aiming to reduce the number of doses by enhancing immunogenicity and cross-protection, effectively improving the accessibility of the product. Preclinical studies have shown that under the same immunization dose, the overall immunogenicity induced by two doses of REC604c is better than the three doses of Merck's Gardasil9.
HPV infection is not only the main cause of cervical cancer in women but can also lead to diseases such as genital warts, oral cancer, and male reproductive system cancer. Public data shows that about 90% of genital warts can be attributed to HPV infection. Globally, countries like the UK, Canada, and Ireland have included HPV vaccination for adolescent males in their national immunization plans, with vaccination strategies similar to those for females. Currently, there are over 300 million eligible males in China, and the market potential is yet to be fully realized.