Legend Biotech lands CAR-T breakthrough designation under new CEO

China’s National Medical Products Administration and the Center for Drug Evaluation has granted Legend Biotech’s investigational CAR-T cell therapy its first breakthrough therapy designation, the company said.

The Chinese biotech, which recently listed on Nasdaq, is the first company to receive a breakthrough therapy status since the Chinese regulators published its first working draft procedures for reviewing breakthrough therapeutics last month. The designation is meant to speed up the approval of novel therapies that treat serious illnesses for which there is no treatment, with preliminary data showing they are better than existing options.

The NMPA’s breakthrough therapy designation for Legend’s ciltacabtagene autoleucel, or cilta-cel, is based on a number on ongoing Phase 1 and 2 studies of the CAR-T cell therapy in China, Japan, and the U.S. The company has been collaborating with Johnson & Johnson since 2017 on global commercialization of the BMCA-targeting cell therapy for treating patients with multiple myeloma.

Last weekend, Legend also announced that its CEO, Yuan Xu, has resigned for personal reasons. The company has appointed Frank Zhang, chairman of Legend’s board of directors and CEO of Genscript Biotech — the company it spun out of earlier this year — to be its new CEO.