China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) announced the completion of subject enrollment and first vaccination in an immuno-bridging study for its recombinant HPV 9-valent vaccine, REC603. The study targets younger-age groups and aims to compare the immunogenicity between REC603 and Gardasil 9. Meanwhile, follow-up on subjects in an efficacy trial for REC603 is being conducted according to the clinical protocol.
Clinical Trial Details
The Phase III clinical trial for REC603 in China comprises three parts: the efficacy trial, the immuno-bridging trial in younger-age groups, and the immunogenicity comparative trial with Gardasil 9. The trial features a multi-center, randomized, blinded, and parallel controlled design with a total of 16,050 participants.
Market Context
Currently, no domestic HPV 9-valent vaccine has been approved for sale in China. The market is currently served by GSK’s Cervarix (bivalent HPV adsorbed vaccine), MSD’s Gardasil 4 and Gardasil 9, Wantai Bio’s Cecolin (bivalent HPV adsorbed vaccine), and Walvax Bio’s bivalent HPV adsorbed vaccine. Phase I clinical data for REC603 indicates that it is safe, well-tolerated, and has a favorable immunogenicity profile. REC603 utilizes an H. polymorpha expression system to achieve high-yield and stable expression of HPV virus-like particles, ensuring the vaccine candidate is more suitable for commercial production.-Fineline Info & Tech
