Legend Biotech’s Cancer Drug Is China’s First Approved for EU Market
Lin Zhiyin
DATE:  May 27 2022
/ SOURCE:  Yicai
Legend Biotech’s Cancer Drug Is China’s First Approved for EU Market Legend Biotech’s Cancer Drug Is China’s First Approved for EU Market

(Yicai Global) May 27 -- Biopharmaceutical firm Legend Biotech’s cancer treatment has become the first Chinese original chimeric antigen receptor T-cell therapy approved for marketing by the European Commission.

The commission approved Carvykti for adults with relapsed and refractory multiple myeloma who have had at least three previous therapies -- a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody -- and have shown disease progression on the last therapy, according to a statement Nanjing-based Legend Biotech released yesterday.

Legend Biotech cooperated with Janssen Biotech, a unit of US pharmaceutical giant Johnson and Johnson, in December 2017 to advance the development and commercialization of Carvykti, which was approved for marketing in the United States at the end of February.

Carvykti is the first Chinese CAR-T drug to enter an overseas market, although it has not yet received domestic marketing approval. There are two CAR-T drugs approved in China, Axicabtagene Ciloleucel and Rrelmacabtagene Autoleucel, developed by Fosun Kite and JW Therapeutics, respectively.

Only seven CAR-T treatments have been approved worldwide. Because of high development costs, they are very expensive. Carvykti costs USD465,000 in the US. The price for the European market has yet to be released.

Founded in 2014, Legend Biotech has facilities in Nanjing, New Jersey in the US, and Dublin in Ireland. The firm is still in the research and development investment stage, as it reported a net loss of USD386 million last year. Revenue was USD89.8 million.

Shares of Legend Biotech [NASDAQ: LEGN] closed up 0.5 percent at USD39.35 in New York yesterday, giving the company a market value of about USD6.1 billion. It listed in June 2020.

Editors: Dou Shicong, Futura Costaglione

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Keywords:   Legend Biotech,CAR-T,Europe