Biological E to make HPV9 vaccine under licensing pact with Recbio

Hyderabad-based vaccine manufacturer Biological E (BE) on Monday announced it has entered a licensing agreement with Chinese pharma firm Jiangsu Recbio Technology Company to produce and commercialise Recbio’s nine-valent Human Papillomavirus (HPV9) vaccine for India and global markets.

The HPV9 vaccine, designed to protect against nine HPV types linked to cervical, vulvar, vaginal, anal and oropharyngeal cancers, as well as genital warts, is currently in Phase 3 clinical trials in China.

As part of the agreement, BE will receive the exclusive right to commercialise the vaccine in India and participate in UNICEF and PAHO tenders in other markets.

Recbio will also provide BE with the drug substance (DS) and transfer the technology to formulate, fill, and package the vaccines. “It will also include technology transfer for DS production at an appropriate time in the future,” Recbio said in a statement.

The collaboration comes at a time when cervical cancer is the fourth leading cause of cancer-related deaths among women worldwide. “In 2019 alone, HPV was linked to an estimated 620,000 cancer cases in women and 70,000 in men,” the companies said in a joint statement.

In India, the estimated number of deaths due to cervical cancer stood at 35,691 in 2023, up from 34,806 in 2022 and 33,938 in 2021, according to a parliamentary response by the Union Health Ministry.

Recbio claims that the nine-valent HPV vaccine is effective in preventing around 90 per cent of cervical cancers and 90 per cent of anal and genital warts.

Commenting on the collaboration, Mahima Datla, Managing Director at BE, said the partnership aligns with the company’s commitment to improve global health by making essential vaccines more accessible and affordable.

The collaboration also marks a significant milestone for Recbio in entering the Indian and international markets, highlighting its potential in the innovative vaccine field.

Liu Yong, Founder, Chairman and Chief Executive Officer (CEO) of Recbio, added that it will work together with BE to accelerate the launch process of the HPV9 vaccine in India.

Following the signing of the technology licence agreement between the two companies, Recbio has begun transferring the necessary technical knowledge, materials, and expertise to BE to produce the HPV9 vaccine.

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

Currently, BE supplies its vaccines to more than 140 countries, and its therapeutic products are sold in India, the US and Europe. It had recently received approval for India’s first 14-valent Pneumococcal Conjugate Vaccine.

Original links: Biological E to make HPV9 vaccine under licensing pact with Recbio | Company News - Business Standard