Sister to Juno's liso-cel, JW's relma-cel lands second-ever CAR-T approval in China
Juno may have stumbled its way to a distant third finish in the CD19 CAR-T race, but its joint venture in China is heading off to a thriving start.
JW Therapeutics, which took its name from co-founders Juno and WuXi AppTec, has scored the second-ever CAR-T approval by China’s National Medical Product Administration just weeks after Fosun Kite, another joint venture, claimed first.
Now sanctioned to treat relapsed or refractory large B-cell lymphoma patients who’ve had two or more lines of systemic therapy, relma-cel was developed on the same cell process platform that spawned Juno’s liso-cel — now Bristol Myers Squibb’s Breyanzi — but a different drug in that it’s tailored for Chinese needs.
Those tweaks also gave rise to a potentially best-in-class profile, according to JW — a claim that will be sure to stoke heated debate among cell therapy makers.
It is the sixth approved CAR-T treatment globally, based on clinical data from more than 100 patients. The NMPA had granted priority review to its LBCL application and a breakthrough therapy designation for follicular lymphoma.
When Juno and WuXi first started the company, the idea was for JW to leverage Juno’s science and research expertise with the savviness in process development, manufacturing, quality control, regulatory and clinical development, as well as commercialization that WuXi, a CRO giant, can offer.
“Our goal has been very clear,” CEO James Li previously said in an interview with Endpoints News. “We want to build the best cell therapy company in China.”
Li, though, wasn’t content with relying on the American partners for discovery, even after striking a new partnership with Lyell. In the summer of 2020, he swooped in to buy Syracuse — the Chinese arm of Bay Area-based Eureka Therapeutics — before flipping to a $300 million IPO on the HKEX.
He’s not too worried about others catching up, either.
“What people don’t realize is it takes a much longer time actually if you want to have a commercially viable process, to have something meaningful you can commercialize,” he said, adding: “I think it’s a great thing if people try to differentiate in early stage. Then whether they can go to commercial or not, I think that’s a big question mark. I would put a big question mark there. And then in that way I do see more and more collaborations between companies. Even more M&A in the space. If somebody has a really good target and demonstrated early on, I would be happy to work with them.”