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China’s Legend Biotech to Build a CAR-T Therapy Production Site in Belgium
Fresh off completing a rolling submission for ciltacabtagene autoleucel (cilta-cel), a CAR-T therapy co-developed with Janssen, China’s Legend Biotech, has announced plans to establish a manufacturing facility in Belgium to boost the production of cilta-cel once it’s FDA approved.
Third Plant for Legend Biotech, a First in Europe
The Belgium facility is going to be the first plant in Europe and the third for Legend Biotech on top of the two in Nanjing, China, and New Jersey, US. For now, details of the plant remain unclear, but the site is expected to go into operation by 2023 and focus on manufacturing cell therapy products.
Also, it would put Legend Biotech in a better position to tap the local talent pool and support global supply as soon as cilta-cel gets approved.
Collaboration with Janssen
Janssen started working with Legend Biotech on developing CAR-T therapy at the end of 2017. The drug is developed for patients with relapsed/refractory multiple myeloma. It received a Breakthrough Therapy Designation (BTD) in the US in December 2019 and also got priority review in May 2021, meaning the FDA will make the decision by November 29th. What’s more, it’s the first CAR-T therapy accepted for review by the China Food and Drug Administration (CFDA).
Approved CAR-T Therapies
If approved, cilta-cel will be the second CAR-T therapy to treat those with relapsed/refractory multiple myeloma as BMS and bluebird bio won the race in March with Abecma, entering the market as the fifth CAR-T therapy and the first for the indication.
Currently, the US FDA has approved five CAR-T therapies, including Abecma and Breyanzi by BMS, Tecartus and Yescarta by Gilead, and Kymriah by Novartis.
Related Article: From Great Challenges to Great Opportunities: An Outlook on US-China Biotech Relationships
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