The drug in question is tislelizumab, which is a PD-1 immunotherapy treatment that has been approved by the China National Medical Products Administration (NMPA) as a treatment for classical Hodgkin’s lymphoma in patients who have received at least two prior therapies.
The treatment becomes BeiGene’s first drug approved in China, while it also becomes the first drug to be manufactured by a multinational contract manufacture service provider in China.
Boehringer Ingelheim will produce the treatment from its Shanghai facility, which was announced as the site for commercial production two years ago.
To reach this stage, Boehringer and BeiGene partnered to create a pilot project for the commercial production of a treatment through a newly developed regulatory pathway for third party companies to biopharmaceutical products for the drug authorization holders.
Jiali Luo, general manager and site head of Boehringer Ingelheim Biopharmaceuticals China, said, “The trial project was smoothly conducted and now proven successful. The newly established model can be of great benefit for the Chinese health care system and provide Chinese patients broader access to more innovative medicine.”
Boehringer has focused on expanding capacity in China, which saw the company announce an additional 2,000L bioreactor added to the same Shanghai facility.
While BeiGene is also working on building out its own manufacturing capacity, through the development of a manufacturing facility in Guangzhou, which will house GE Healthcare’s ‘off-the-shelf’ factory for the production of monoclonal antibodies.
