24 August 2020 - - China-based commercial stage biopharmaceutical Company Bio-Thera Solutions, Ltd (688177.SH) and BeiGene, Ltd. (NASDAQ: BGNE) (HKEX: 06160) have executed a license, distribution, and supply agreement for China for Bio-Thera's BAT1706, an investigational biosimilar to Avastin (bevacizumab), the companies said.

The China National Medical Products Administration recently accepted Bio-Thera's Biologics License Application for BAT1706. Bevacizumab has been approved in China for advanced, metastatic, or relapsed non-small cell lung cancer and metastatic colorectal cancer.

The agreement is subject to approval by the shareholders of Bio-Thera at a meeting to be held in September 2020.

Under the terms of the agreement, Bio-Thera has agreed to grant BeiGene the right to develop, manufacture, and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan. Bio-Thera will retain rights outside of the partnered territory.

Bio-Thera will receive an upfront payment and is eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of USD165 m. Bio-Thera will also be eligible to receive tiered double-digit royalties on future net product sales.

BAT1706 is a monoclonal antibody that is in development by Bio-Thera Solutions as a potential biosimilar to Avastin.

BAT1706 works by binding to the vascular endothelial growth factor protein. In the United States, Avastin is indicated for the treatment of patients with metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer, and hepatocellular carcinoma.

BAT1706 is an investigational compound and has not received regulatory approval in any country. The China NMPA accepted the Biologics License Application for BAT1706 in June 2020.

Bio-Thera plans to file for marketing approval of BAT1706 in the United States and European Union in 4Q20.

Bio-Thera Solutions, 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.