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.
“This is an important milestone, not only to ensure the supply of medicines for patients in China, but also for the rapidly emerging Chinese biopharmaceutical Research & Development landscape,” said BeiGene CEO John Oyler in a statement.
In 2014 China’s drug regulator — since renamed the National Medical Products Administration — began piloting a new Marketing Authorization Holder system under which drugmakers without manufacturing capabilities can still apply for marketing approval. This move opened up the option of enlisting contract manufacturers and signified a complete break from the previous system, where developers must have manufacturing authorization to market a drug.
While BeiGene does have its own biologics manufacturing plant in Guangzhou, it’s also inked a separate deal with Catalent to produce its first commercial drug, zanubrutinib (recently christened Brukinsa in the US).
SVB Leerink anticipates BeiGene will launch tislelizumab in early 2020. The initial indication is third-line relapsed/refractory Hodgkin’s lymphoma, familiar terrain for anyone who’s been following Innovent’s Tyvyt or Jiangsu Hengrui’s camrelizumab. But BeiGene will have top-line Chinese data in non-small cell lung cancer coming later this year, and is plotting supplemental OKs for urothelial cancer, hepatocellular carcinoma and more.
“This is BeiGene’s first internally discovered drug approved in China,” the analysts noted. “The approval was based on results from a single-arm pivotal Phase 2 trial, in which tislelizumab demonstrated a 76.9% objective response rate (ORR) via independent review committee (IRC) assessment, including a 61.5% complete response (CR) rate.”
Their model estimates $85 million in 2020 China revenue for tislelizumab, partly from “meaningful off-label sales” — as the recent National Reimbursement Drug List update featured Innovent’s PD-1 for Hodgkin’s lymphoma (at about $1,100 per month) but not other checkpoints in larger indications.
At one point Celgene was partnered on this drug as part of a portfolio swap which had BeiGene in charge of marketing Abraxane, Revlimid and Vidaza in China, but cut it loose as soon as it got gobbled up by Opdivo maker Bristol-Myers Squibb. BeiGene’s development successes bode well for Amgen, which recently paid $2.7 billion for a roughly 20% stake in the biotech and entrusted its R&D team with some of its own projects.