Biological E, Recbio collaborate to produce HPV9 vaccine
Recbio to complete technology transfer while BE will manufacture HPV9 vaccine for India, UNICEF and PAHO tender markets
Jiangsu Recbio Technology Company, a Chinese biopharmaceutical company, announced that they have entered into a licensing cooperation agreement and has commenced the technology transfer of its Recombinant 9-valent HPV (HPV9) vaccine, REC603, to Biological E. Recbio will provide BE with Drug Substance (DS) and transfer technology to formulate, fill, and package vaccines. It will also include technology transfer for DS production at an appropriate time in the future.
According to the agreement, BE will receive the exclusive right to commercialise the vaccine in India and participate in UNICEF & PAHO tenders in other markets.
The HPV9 vaccine is a recombinant vaccine designed to protect against nine types of Human Papillomavirus (HPV), including those responsible for cervical, vulvar, vaginal, anal, and oropharyngeal cancers, as well as genital warts.
In 2019, HPV was linked to an estimated 620,000 cancer cases in women and 70,000 in men. Preventive vaccination, alongside HPV screening and treatment of pre-cancerous lesions, is a key strategy in reducing the global burden of HPV-related cancers.
Cervical cancer is the fourth leading cause of cancer-related deaths among women worldwide. The 9-valent HPV vaccine is effective in preventing around 90 percent of cervical cancer and 90 percent of anal and genital warts. Recbio’s core product, REC603, is for people ranging from 9 to 45 years old and is currently in the crucial Phase III clinical trials in China.
Following the signing of the technology license agreement, Recbio has begun transferring the necessary technical knowledge, materials, and expertise to BE to produce the HPV9 vaccine. Recbio will continue to support BE in clinical development and regulatory approvals to ensure a seamless transition. By leveraging BE’s advanced manufacturing capabilities, this partnership aims to increase the availability of an affordable HPV9 vaccine in India and across international markets.
BE will begin large-scale manufacturing of the HPV9 vaccine once the Technology transfer is completed.