BeiGene scores first China OK with PD-1 — to be manufactured by Boehringer Ingelheim
On December 17, 2018, Junshi Biosciences notched the landmark approval for a made-in-China PD-(L)1 checkpoint inhibitor by Chinese regulators. Barely a year later, the fourth homegrown PD-1 is making its way to a market that has since seen several more firsts even whilst getting crowded.
The approval for BeiGene’s tislelizumab just before 2019 ended is also marking a new historic event: the first time a foreign partner will be producing the marketed drug under a reformed contract manufacturing regulatory system. Boehringer Ingelheim, a partner since 2013, will be supplying the PD-1 antibody for commercial use using a Shanghai facility.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.
