With approval for China's 2nd CAR-T therapy, Juno, WuXi joint venture goes up against Gilead and Fosun's Yescarta

Nurse about to give an infusion
JW Therapeutics' relma-cel nod comes about two months after Fosun Kite claimed China's first CAR-T approval for Yescarta. (Getty/fotografixx)

Bristol Myers Squibb’s CAR-T drug Breyanzi has a sister med on the market.

JW Therapeutics, a joint venture between Bristol Myers’ Juno Therapeutics and WuXi AppTec, has won approval in China for CD19 CAR-T cell therapy relmacabtagene autoleucel (relma-cel) to treat large B-cell lymphoma after at least two prior lines of systemic therapy.

Relma-cel marks China’s second approved CAR-T therapy. Fosun Kite Biotechnology, a joint venture between Fosun Pharma and Gilead Sciences’ Kite Pharma, claimed the first-to-market title in June with their approval for Yescarta in the same disease setting.

Just like the relationship between Kite’s two CD19 CAR-T products, Yescarta and Tecartus, relma-cel expresses the same CD19-targeting CAR construct as Breyanzi. The difference is that relma-cel uses a manufacturing process developed in China that doesn’t require separate CD4 and CD8 T-cell production trains, JW says

In a single-arm, pivotal trial dubbed Reliance, relma-cel triggered a response in 75.9% of 58 evaluable patients at any time point during the study. Further, investigators saw no signs of cancer in 51.7% of patients throughout the study as of an analysis last June.

Among all 59 treated patients, only 5.1% and 3.4% experienced cytokine release syndrome and neurological toxicity, respectively, at grade 3 or above. The two side effects are commonly linked to CAR-T treatments. In a Friday statement, JW said relma-cel’s high response rates and low rates of CAR-T-related side effects “may provide a best-in-class CAR-T therapy profile.”

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To prepare for the launch, JW has established a 10,000-square-meter manufacturing facility in Suzhou, China. The plant has the capacity to support the production of autologous CAR-T treatment of up to 2,500 patients per year, according to the company’s half-year report released last week.

An in-house commercial team of 90 people is ready to roll, and JW has tapped Shanghai Pharma as its national distributor to take care of the logistics.

But the more important question is perhaps pricing. Neither Fosun Kite nor JW has disclosed prices for their CAR-T drugs. Given how much CAR-T drugs cost in the Western world, the fear is that they will be too pricey for Chinese patients.

In its half-year 2021 report, JW said it’s “targeting to establish a multi-layer insurance system by cooperating with different partners” to improve the affordability of relma-cel.

Yescarta has an upper hand, though; its June approval allows it to be included for pricing and coverage negotiation in the upcoming National Reimbursement Drug List revision.

RELATED: Bristol Myers' cell therapy Breyanzi, fresh off an FDA nod, eyes earlier lymphoma use with first-in-class win

Besides third-line LBCL, JW is also testing relma-cel in follicular lymphoma, mantle cell lymphoma, and second-line LBCL. The company is also developing a BCMA-targeted CAR-T that uses the same CAR construct as Bristol Myers’ now discontinued orva-cel.

The rivalry between Fosun Kite and JW is merely a tip of the iceberg of China’s increasingly crowded cell therapy landscape.

Legend Biotech, through a collaboration with Johnson & Johnson, is close to the U.S. market for BCMA hopeful cilta-cel after scoring an FDA priority review in multiple myeloma. Allogene Therapeutics recently formed a joint venture with China’s Overland Pharmaceuticals to develop the U.S. biotech’s allogeneic, or off-the-shelf, CAR-T therapies for the Chinese market.

As of June 30, 2020, China has recorded 357 clinical trials for CAR-T therapies, including 175 trials for CD19-directed products, according to a recent article published in Cellular & Molecular Immunology. That’s compared with 256 CAR-T trials registered in the U.S.