martes, 7 de julio de 2020

Juno makes a move on Kite Pharma in China CAR-T race

STAT China
Jonathan Chan

Juno makes a move on Kite Pharma in China CAR-T race

China leads the world in the number of CAR-T clinical trials but has yet to approve one for the market. Last week, JW Therapeutics submitted a new drug application for its CAR-T cell therapy, JWCAR029, records from China’s Center for Drug Evaluation showed.

The therapy targets CD19, a biomarker present in many types of B cell cancers. According to clinicaltrials.gov, the cell therapy in currently in Phase 2 development for the treatment of recurrent or refractory non-Hodgkin lymphoma.

Established in 2016, JW Therapeutics is a joint venture between Juno Therapeutics — now under Bristol Myers Squibb — and WuXi AppTec. It’s the second group in China to submit a CAR-T product for approval. Fosun Kite, a Shanghai-based joint venture between Fosun Pharma and Kite Pharma, crossed the finish line first when it submitted axicabtagene ciloleucel, whose brand name is Yescarta, for regulatory approval earlier in February.

Fosun Kite has been operating in China since January 2017 to establish the R&D and manufacturing capabilities for T-cell-based therapies, including Yescarta, which was approved in the U.S. later that year. Since China now considers foreign clinical data and regulatory approvals in its own drug review process, Fosun Kite’s application with Yescarta could have a leg up on JWCAR029.

Last month, JW Therapeutics completed its Series B financing, netting the partnership an additional $100 million to fund its pipeline buildout and potential commercialization of JWCAR029.

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