When China lightened up its rules requiring biologic drug developers to own their own manufacturing, Boehringer Ingelheim took a leap of faith and built a plant there to do contract work under a pilot project. That faith has paid off.
The Chinese unit of the German drugmaker has become the first CDMO to manufacture an approved drug under the country’s Marketing Authorization Holder (MAH) system. It accomplished that with the production of the monoclonal antibody tislelizumab, BeiGene's anti-PD-1 checkpoint inhibitor that China recently approved.
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“The trial project was smoothly conducted and now proven successful,” Jiali Luo, GM of Boehringer Ingelheim Biopharmaceuticals China said in a statement. “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 opened the first phase of the $77 million facility in 2017 with a single-use bioreactor that can handle clinical supplies or commercial production up to 2000 liters. It was designed so that 2000-L single-use bioreactors and additional fill/finish capabilities can be added when demand calls for it.
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The company already had biopharmaceutical production sites in Biberach, Germany, Vienna, Austria and Fremont, California when in 2013 it announced an alliance with Zhangjiang Biotech & Pharmaceutical Base Development Company (ZJ Base) in Pudong, Shanghai, to build the facility under BI's tutelage. It said it would make biologics under China’s pilot program. The following year Boehringer Ingelheim China Biopharmaceuticals began producing clinical material supply at 100-L and 500-L scales and in 2016 it took on the BeiGene project.
Beijing-based BeiGene won approval for tislelizumab in China just a week ago but today said it has optioned the rights to Leap Therapeutics’ cancer drug DKN-01 in most of the Asia-Pacific region so that it can test a combo of Leap’s anti-DKK1 antibody with its recently approved anti-PD-1 checkpoint inhibitor.