Hyderabad-based biotech major, Biological E Limited (BE), has announced a partnership with China’s Jiangsu Recbio Technology Company Limited to manufacture and distribute a 9-valent Human Papillomavirus (HPV9) vaccine.
The HPV9 vaccine is designed to protect against HPV types linked to cervical, vulvar, vaginal, anal, and oropharyngeal cancers, as well as genital warts. It is currently in Phase III clinical trials in China and is intended for individuals aged 9 to 45.
HPV is the most common infection that spreads mainly through skin-to-skin contact. Many people with HPV do not develop any symptoms but can still transmit the virus through sexual contact. Symptoms may include warts on the genitals or surrounding skin.
There is currently no cure for the virus. There are more than 100 types of human papillomavirus. Some cause skin growths called warts, while others are linked to cancer.
If administered before HPV infection occurs, the vaccine can prevent most cases of cervical cancer.
The company stated that the agreement marks the start of a technology transfer process that will enable it to manufacture and commercialise the vaccine in India and global markets, including through tenders by UNICEF and the Pan American Health Organisation (PAHO).
“This partnership comes at a critical time when there is a growing demand globally for affordable and effective HPV vaccines,” said Mahima Datla, Managing Director of Biological E Limited.
“We are committed to ensuring that this life-saving vaccine reaches those who need it the most, both in India and beyond,” she added.
Dr Liu Yong, Founder, Chairman, and CEO of Recbio, described the agreement as a major step forward for the company’s global reach.
“This cooperation is another significant step for Recbio as we enter new global markets. Together with BE, we aim to accelerate the launch of the HPV9 vaccine in India and make meaningful contributions to public health worldwide,” Dr Yong said.
The global burden of HPV-related cancers remains substantial, with the virus accounting for an estimated 620,000 cancer cases in women and 70,000 in men in 2019.
Cervical cancer is the fourth leading cause of cancer-related deaths among women globally. Experts believe the 9-valent vaccine could prevent up to 90 per cent of cervical cancers and cases of anal/genital warts.
Under the agreement, Recbio will supply BE with the drug substance and transfer the technology required to formulate, fill, and package the HPV9 vaccine – REC603 – which targets nine strains of the virus.
Going forward, Recbio will also support BE in developing the capacity to manufacture the drug substance within India.
Technology transfer activities are already underway, with Recbio assisting BE in clinical development and regulatory approval processes. BE is expected to begin large-scale production once the transfer is complete.
The partnership is expected to strengthen India’s role as a global vaccine manufacturing hub and support ongoing efforts to increase access to HPV vaccines in low- and middle-income countries.
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