BioLineRx has announced that it has signed an out-licensing agreement with Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), the leading Chinese pharmaceutical company in the liver disease therapeutic area, for the development and commercialization of BL-8030, an orally available treatment for the Hepatitis C virus (HCV).
Under the terms of the agreement, BioLineRx will grant CTTQ exclusive rights to develop, manufacture and commercialize BL-8030 in China and Hong Kong.
CTTQ will pay BioLineRx an upfront license fee, plus future development, regulatory and commercialization milestones, for a total potential deal value of approximately $30 million.
In addition, BioLineRx has the right to receive high single-digit royalties on future sales of the drug. BioLineRx will retain the right to develop and commercialize BL-8030 in other parts of the world.
CTTQ will adhere to FDA and EMA guidelines in pre-clinical development and manufacturing of BL-8030. BioLineRx will have access to all development and regulatory data generated by CTTQ, as well as the right to use this data for commercialization and regulatory purposes in all areas of the world outside of China and Hong Kong.
“We look forward to developing and commercializing BL-8030 with CTTQ, the leading pharmaceutical company in China in the field of liver diseases,” said Kinneret Savitsky, Ph.D., Chief Executive Officer of BioLineRx.
Savitsky continued, "We are proud that since in-licensing this promising pre-clinical asset just over one year ago, we have found a strong partner for the further development of BL-8030 in China, which is a significant market in the HCV field. 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. 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.”
"We are excited to include BL-8030 as a new asset in our pipeline," said Mr. Jian Sun Emba, President of CTTQ. "Unfortunately, the prevalence of HCV is relatively significant in China, with reports of 3.2% of the population (amounting to approximately 43 million individuals) suffering from this chronic and debilitating disease. Thus there is a clear and urgent need to develop new, safe and effective treatments for HCV patients in China. 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."
Professor Philippe Halfon, world-renowned scientist for his work on HIV, HPV (human papilloma virus causing cervical cancer) and Hepatitis, and a co-inventor of BL-8030, said, "BL-8030 has shown promising results in pre-clinical studies, and may become an important part of combination therapies for HCV. Current treatments are only partially effective and adverse effects are common, so there is a clear need for new drugs that will be both safe and effective."