Boehringer Ingelheim's Bet on Chinese CDMO Market Pays Off with Beigene's Mab Approval
1/6/2020
Germany-based Boehringer
Ingelheim opened this €70 million biologics manufacturing facility in Shanghai
to produce cell-based drugs targeted primarily at China.
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.
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.