In a significant development for global health, Hyderabad-based Biological E. Limited (BE) has joined hands with Chinese biopharmaceutical firm Jiangsu Recbio Technology Company Limited to produce and distribute the 9-valent Human Papillomavirus (HPV9) vaccine, REC603. This collaboration involves a full technology transfer process and marks a major step toward increasing access to affordable HPV vaccines in India and beyond.
As part of the agreement, Recbio will transfer the technology and provide the drug substance (DS) required for the vaccine to BE. Initially, BE will receive and formulate the vaccine, handling the filling and packaging processes. In the future, technology to produce the DS itself will also be transferred. BE will hold exclusive commercialization rights for the vaccine in India and will also participate in global tenders from organizations such as UNICEF and the Pan American Health Organization (PAHO).
The HPV9 vaccine, REC603, is designed to protect against nine types of HPV, including those known to cause cervical, vaginal, vulvar, anal, and oropharyngeal cancers, as well as genital warts. HPV is a group of more than 200 viruses, some of which are high-risk and can cause cancer. Although most infections clear up on their own, persistent infection with high-risk HPV types can lead to various forms of cancer. In 2019 alone, HPV-related cancers were responsible for an estimated 620,000 cases in women and 70,000 in men globally.
Cervical cancer remains the fourth most common cause of cancer-related death in women worldwide. The 9-valent HPV vaccine has proven to prevent nearly 90% of cervical cancer cases and genital warts. REC603, Recbio’s flagship HPV vaccine, is currently in Phase III clinical trials in China and is intended for individuals aged 9 to 45 years.
Recbio has already initiated the process of transferring its technical knowledge, materials, and expertise to Biological E., enabling the Indian company to take over the vaccine’s production. BE will begin large-scale manufacturing once the technology transfer is complete. Recbio will also continue to support BE through clinical development and regulatory approval processes to ensure a smooth rollout.
This partnership is timely, considering the increasing global demand for cervical cancer prevention. Leveraging BE’s established manufacturing strength and global distribution experience, the collaboration aims to ensure broader access to this critical vaccine, especially in low- and middle-income countries.
Dr. Liu Yong, Founder, Chairman, and CEO of Recbio, expressed optimism about the collaboration, stating, “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 contribute meaningfully to global public health.”
Echoing this sentiment, Ms. Mahima Datla, Managing Director of Biological E., 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. Together, we aim to ensure this life-saving vaccine reaches those who need it the most.”
