On August 24, 2020 Bio-Thera Solutions, Ltd., a commercial stage biopharmaceutical company (688177.SH) and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), reported that the companies have executed a license, distribution, and supply agreement for China for Bio-Thera’s BAT1706, an investigational biosimilar to Avastin (bevacizumab) (Press release, BioThera Solutions, AUG 24, 2020, View Source [SID1234563981]). The China National Medical Products Administration (NMPA) recently accepted Bio-Thera’s Biologics License Application (BLA) 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.
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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 $165 million. Bio-Thera will also be eligible to receive tiered double-digit royalties on future net product sales.
"We are focused on bringing impactful and affordable medicines to people around the world. BAT1706, a potential biosimilar for Avastin (bevacizumab), could become an important treatment option for solid tumor indications in China such as colorectal, lung, and liver cancers. It brings us the opportunity to broaden our portfolio of commercial and registration-stage products in China and is complementary to our in-licensed and internally discovered medicines, such as tislelizumab, our marketed anti-PD-1 antibody that has also been filed in China for lung and liver cancer indications," said Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene.
"We are delighted to enter a collaboration with BeiGene, a company with significant expertise and a robust pipeline in oncology, as it will enable us to deliver BAT1706 to more patients as soon as possible," said Dr. Shengfeng Li, CEO of Bio-Thera. "This collaboration allows Bio-Thera to leverage BeiGene’s experience and expertise to accelerate the development and commercialization of BAT1706 as a single agent regimen or as a component of combinational therapies, and to help increase patient access to this important cancer therapeutic at affordable prices."
About BAT1706
BAT1706 is a monoclonal antibody (mAb) that is in development by Bio-Thera Solutions as a potential biosimilar to Avastin. BAT1706 works by binding to the vascular endothelial growth factor (VEGF) 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 (BLA) for BAT1706 in June 2020. Bio-Thera plans to file for marketing approval of BAT1706 in the United States and European Union in the fourth quarter of 2020.