Boehringer Ingelheim has signed a commercial supply agreement for biotechnology firm BeiGene’s tislelizumab.
Tislelizumab is an investigational humanised monoclonal antibody being developed to bind to the PD-1 receptor known to down-regulate the immune system through prevention of T-cell activation.
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Under the agreement, Boehringer will manufacture tislelizumab as part of an exclusive multi-year arrangement in the country.
Boehringer will produce the drug candidate at its biopharmaceutical manufacturing facility in Shanghai under a Marketing Authorization Holder (MAH) trial project initiated by the companies.
Boehringer Ingelheim Biopharmaceuticals (China) general manager Dr Jiali Luo said: “The agreement marks the first biopharmaceutical MAH trial project entering into commercial supply in China.
“We are confident that our quality competence and contract manufacturing capabilities are best-in-class, and excited to plan for the commercial supply of tislelizumab, which has the potential to help patients with a broad array of cancers as both a monotherapy and in combination with other therapies.”
The supply agreement also provides BeiGene with select preferred rights for capacity expansion in the future by Boehringer in China.
BeiGene founder, CEO and chairman John Oyler said: “In addition to working with Boehringer Ingelheim, we are also building our manufacturing facility for biologics commercial supply in Guangzhou, China, in a joint venture with the Guangzhou Development District, that we expect will further expand our capacity to meet anticipated demand for tislelizumab and other biologics in our pipeline.”
