HPV9 vaccine: Biological E to get exclusive right to commercialize REC603 in India
Biological E will begin large-scale manufacturing of the HPV9 vaccine once the Technology transfer is completed.
Hyderabad: Jiangsu Recbio Technology Company Limited, a Chinese biopharmaceutical company, has announced that they have entered into a licensing cooperation agreement, and have commenced the technology transfer of their Recombinant 9-valent HPV (HPV9) vaccine, REC603, to Biological E. Limited, a Indian vaccine and pharmaceutical company.
Recbio will provide Biological E 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, Biological E will receive the exclusive right to commercialize 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.
HPV is a group of over 200 known viruses, some of which are classified as high-risk due to their potential to cause cancer. While most HPV infections are controlled by the body's immune system, persistent infections with high-risk HPV types can lead to cervical cancer and other malignancies affecting the vulva, vagina, mouth, throat, penis, and anus. In 2019 alone, 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 Biological Eto produce the HPV9 vaccine. Recbio will continue to support Biological E in clinical development and regulatory approvals to ensure a seamless transition.
This collaboration comes at a crucial time, as the global demand for cervical cancer prevention is at an all-time high.
"By leveraging Biological E’s advanced manufacturing capabilities, this partnership aims to increase the availability of an affordable HPV9 vaccine in India and across international markets," the release stated.
Biological E will begin large-scale manufacturing of the HPV9 vaccine once the Technology transfer is completed.
Dr. Liu Yong, Founder, Chairman, and CEO of Recbio, stated, "We are delighted to collaborate with Biological E. This cooperation is another significant progress for Recbio in expanding into international markets., We will work together with our Indian partner to accelerate the launch process of the HPV9 vaccine in India, and jointly make greater contributions to global public health."
Ms. Mahima Datla, Managing Director, Biological E. Limited, said: “We are pleased to partner with Recbio to bring the HPV9 vaccine to India and other countries. This collaboration aligns with our commitment to improving global health by making essential vaccines more accessible and affordable as well as to promote a lasting legacy of innovation and stewardship. We, along with Recbio, are committed to creating a healthier and more robust future by ensuring that this life-saving vaccine is delivered to those who need it the most.”
