Tony Hagen is senior managing editor for The Center for Biosimilars®.
From China to Taiwan, BeiGene and Bio-Thera Solutions hope to capture a large share of the bevacizumab biosimilar market.
Two China-based companies have reached a tentative agreement to commercialize a bevacizumab biosimilar in the Chinese market assuming approval is granted by the China National Medical Products Administration (NMPA).
Bio-Thera Solutions, based in Guangzhou, and BeiGene, of Beijing, said the licensing agreement is for Bio-Thera’s BAT1706, an investigational biosimilar to the reference product Avastin, which in China is indicated for advanced, metastatic, and relapsed non—small cell lung cancer and metastatic colorectal cancer.
Terms of the Deal
BeiGene would have the rights to develop manufacture and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan. Macau is an independently administered territory of China. Taiwan is a self-governed country whose medicinal products are approved by the Taiwan Food and Drug Administration.
The deal calls for Bio-Thera to receive an upfront payment and milestone payments up to a total of $165 million. In addition, Bio-Thera would receive royalties on future sales. Final approval of the marketing deal is subject to shareholder approval.
“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,” said Shengfeng Li, CEO of Bio-Thera.
BeiGene believes the bevacizumab biosimilar has the potential for wide acceptance in China. “BAT1706…could become an important treatment option for solid tumor indications in China such as colorectal, lung, and liver cancers,” said Xiaobin Wu, PhD, president of BeiGene. "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."
The NMPA accepted the biologics license application for BAT1706 in June 2020. Bio-Thera plans to file for BAT1706 marketing approval in the United States and Europe by the end of 2020.
Bio-Thera has 5 drug candidates in late-stage clinical trials, one of which, Qletli, is an adalimumab biosimilar.
BeiGene has more than 4200 employees in China, the United States, Australia, Europe, and other countries. It has 2 “internally discovered” oncology products: zanubrutinib (Brukinsa), a Bruton tyrosine kinase inhibitor that is marketed in the United States and China; and the anti—PD-1 antibody tislelizumab, which is sold in China. The company aims to license and distribute in China other oncology products from Amgen, Celgene Logistics Sàrl, and EUSA Pharma.
In December 2019, Bio-Thera received NMPA approval to initiate a phase 1 clinical study to evaluate the pharmacokinetics and safety of BAT2206, a proposed ustekinumab biosimilar referencing Stelara.