REC603 / Jiangsu Rec-Biotech - LARVOL DELTA

Biological E. to produce Jiangsu Recbio Tech’s HPV9 vaccine REC603 (The Hindu) - "Hyderabad-based vaccine maker Biological E. will produce Chinese biopharmaceutical firm Jiangsu Recbio Technology Company’s recombinant 9-valent HPV (HPV9) vaccine REC603 under a licensing cooperation agreement the companies announced on Monday....BE will receive exclusive right to commercialise the vaccine in India and participate in UNICEF and PAHO tenders in other markets. It will begin large-scale manufacturing of the HPV9 vaccine once the technology transfer is completed....Following the license agreement, Recbio has started transferring necessary technical knowledge, materials and expertise to BE for producing the vaccine. It will continue to support BE in clinical development and regulatory approvals."

Commercial • Cervical Cancer

Jiangsu Recbio Technology Co., Ltd. announced 2023 interim results report and latest progress (PRNewswire) - "Innovative vaccine company Recbio...announced its latest progress and interim results for 2023...We have completed the 18th month follow-up visit and are conducting the 24th month follow-up visit observation. We plan to take the pathological endpoint for interim analysis and submit BLA application to the NMPA for REC603 after meeting the conditions...The Company has completed the three doses vaccination in the two studies of REC603 immuno-bridging trial in the younger-age groups and the immunogenicity comparative trial with Gardasil®9....Our Phase III clinical protocol for the 9-valent HPV vaccine strictly follows the guidelines of the regulatory authorities; We have the largest HPV 9-valent Phase III clinical trial subjects in China and are conducting clinical trials in Henan, Shanxi and Yunnan provinces with high HPV infection rates. Currently, the Company is conducting follow-up visits according to the established protocol."

Trial status • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor • Vaginal Cancer • Vulvar Cancer

Recbio announces Phase III Clinical Trial Progress Of Recombinant HPV 9-Valent Vaccine (PRNewswire) - "Jiangsu Recbio Technology Co., Ltd...is pleased to announce that, the Company has recently completed the subject enrollment and first dose vaccination in respect of immuno-bridging study of its recombinant HPV 9-valent vaccine, REC603, in younger-age groups and the study to compare the immunogenicity between REC603 and Gardasil^® 9. At the same time, follow-up on the subjects of REC603's efficacy trial is being conducted in accordance with the clinical protocol."

Enrollment closed • Trial status • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor • Vaginal Cancer • Vulvar Cancer