Biopharmaceutical development company BioLineRx has collaborated with Chinese pharmaceutical company Jiangsu Chia-tai Tianqing Pharmaceutical (CTTQ) to develop and commercialise oral hepatitis C drug BL-8030.

Under the out-licensing agreement, CTTQ will develop, manufacture and commercialise the pre-clinical, second-generation NS3 protease inhibitor in China and Hong Kong.

In exchange, BioLineRx will receive an upfront license fee, along with future development, regulatory and commercialisation milestones worth approximately $30m.

Retaining the right to develop and commercialise BL-8030 in other parts of the world, BioLineRx is also eligible for projected sales-based royalties.

BioLineRx chief executive officer Dr Kinneret Savitsky said the company found a strong partner for the further development of BL-8030 in China.

“We believe that given CTTQ’s extensive experience in the liver disease area, it will swiftly advance the development of BL-8030 at the highest global standards,” Savitsky said.

“In parallel to collaborating with CTTQ to advance the drug, we intend to continue discussions with relevant partners for this project in other parts of the world.”

CTTQ will carry out pre-clinical development and manufacturing of BL-8030 as per the FDA and EMA guidelines, as well as generate development and regulatory data.

The data can be accessed and used by BioLineRx for commercialisation and regulatory purposes in all areas across the globe, excluding China and Hong Kong.

CTTQ president Jian Sun Emba said the prevalence of the Hepatitis C virus (HCV) is quite significant in China, with an estimated 3.2% of the population suffering from the disease.

“Thus there is a clear and urgent need to develop new, safe and effective treatments for HCV patients in China,” Jian Sun Emba said.

“After conducting a thorough due diligence process, we sincerely believe that BL-8030, even though still in pre-clinical development, has the potential to become an important addition to HCV combination therapies.”

Image: Electron micrograph of hepatitis C virus purified from cell culture.