BAT1706 has completed extensive biosimilar studies, including a global Phase III study, and BLAs were filed with NMPA, FDA and EMA in 2020.
Under the agreement, Bio-Thera will maintain responsibilities for development, manufacturing, and supply of BAT1706. Sandoz will commercialize the medicine in all markets covered by the agreement upon regulatory approval.
The license covers the US, Europe, Canada and a majority of the remaining international markets that are not covered under other BAT1706 partnerships.
Bio-Thera will receive an upfront payment, potential milestone payments along with royalties on product sales.
BAT1706 is a proposed bevacizumab biosimilar developed by Bio-Thera. Bevacizumab is a humanized monoclonal antibody that targets VEGF.
It can specifically bind to VEGF and block the binding of VEGF to its receptor, thereby reducing neovascularization, inducing the degradation of existing blood vessels, and thereby inhibiting tumor growth.
The reference medicine bevacizumab has been approved in United States and Europe for several indications including advanced, metastatic, or recurrent non-small cell lung cancer, metastatic colorectal cancer and certain types of renal cell carcinoma, ovarian cancer, cervical cancer, and glioblastoma.
Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases.
As a leader in the next generation antibody discovery and engineering, the company has advanced six candidates into late-stage clinical trials and one of which, QLETLI, a biosimilar to adalimumab, is available to patients in China.
In addition, the company has multiple candidates in early stage clinical or entering clinical studies, including differentiated and innovative anti-OX40, anti-TIGIT, and anti-PD-L1/CD47 bispecific antibodies.
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