Biological E. Ltd (BE) has entered into a licensing cooperation agreement with Jiangsu Recbio Technology Co Ltd. to produce and commercialise the Chinese company’s recombinant 9-valent Human Papillomavirus (HPV9) vaccine, REC603, in India and select global markets.

REC603 is designed to protect against nine types of HPV, including those responsible for cervical, vulvar, vaginal, anal, and oropharyngeal cancers, as well as genital warts. The vaccine is currently in Phase III clinical trials in China.

With a population of approximately 1.44 billion and around 23 million newborns each year, India is believed to have an enormous market potential for HPV vaccines.

Under the terms of the deal, 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.

Additionally, BE will receive the exclusive right to commercialize the vaccine in India and participate in international tenders issued by the United Nations International Children’s Emergency Fund (UNICEF) and the Pan American Health Organization (PAHO). 

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,” added Datla.

According to Recbio, their HPV 9-valent vaccine is effective in preventing around 90 percent of cervical cancer, anal cancer, and genital warts. 

As the core product of the company, REC603 is indicated for individuals aged 9 to 45 and is currently in the critical follow-up phase of Phase III clinical trials in China. 

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."

Recbio has already begun transferring the necessary technical knowledge, materials, and expertise to BE to produce the HPV9 vaccine. It will continue to support BE in clinical development and regulatory approvals to ensure a seamless transition.

BE will begin large-scale manufacturing of the HPV9 vaccine once the technology transfer is completed.

Headquartered in Hyderabad, BE is dedicated to the development, production, and supply of vaccines and therapeutic drugs.

Its product portfolio includes 10 vaccines approved by the World Health Organisation (WHO) and 10 generic injectables approved by the US Food and Drug Administration (USFDA).