Hyderabad-based Biological E. Limited (BE) has entered into a strategic partnership with Jiangsu Recbio Technology Co. Ltd., China, to manufacture and distribute a 9-valent Human Papillomavirus (HPV9) vaccine.
Currently undergoing Phase III clinical trials in China, the HPV9 vaccine is designed to offer protection against nine HPV types associated with cervical, vaginal, vulvar, anal, and oropharyngeal cancers, as well as genital warts. It is intended for individuals aged 9 to 45 years.
As part of the agreement, Recbio will transfer the necessary technology and supply the drug substance to BE, enabling the Indian company to formulate, fill, and package the vaccine—REC603—for both domestic and international markets. This includes participation in global tender processes by agencies such as UNICEF and the Pan American Health Organization (PAHO).
Mahima Datla, Managing Director of Biological E Limited, highlighted the importance of the collaboration, stating, “This partnership comes at a crucial time when the need for affordable, effective HPV vaccines is growing globally. We are committed to making this life-saving vaccine accessible to those who need it most—in India and across the world.”
Dr. Liu Yong, Founder, Chairman, and CEO of Recbio, echoed this sentiment, calling the agreement a significant milestone. “Our collaboration with BE expands Recbio’s global footprint and accelerates the availability of the HPV9 vaccine in India, contributing meaningfully to global public health,” he said.
The partnership aims to address the pressing global burden of HPV-related cancers, which accounted for an estimated 620,000 cases among women and 70,000 among men in 2019. Cervical cancer, in particular, remains the fourth leading cause of cancer-related deaths in women worldwide. Experts estimate that the 9-valent HPV vaccine could prevent up to 90% of cervical cancer cases and a significant proportion of genital warts.
Beyond vaccine formulation and packaging, Recbio will assist BE in developing in-house capabilities to manufacture the drug substance in India. Technology transfer is already underway, alongside support for clinical development and regulatory approvals. BE is expected to initiate large-scale production following completion of the transfer.
The collaboration reinforces India’s growing role as a global vaccine manufacturing hub and is expected to significantly improve access to HPV vaccines in low- and middle-income countries.