China has officially approved its first CAR T-cell therapy product, Axicabtagene Ciloleucel Injection (also known as Yescarta, developed by Fosun Kite, a joint venture between Fosun Pharma and Gilead Kite. The announcement from the China National Medical Products Administration (NMPA) marks a significant milestone in the country’s medical landscape.
This CAR-T therapy is intended for adult patients with relapsed or refractory large B-cell lymphoma who have undergone second-line or higher systemic treatments. It includes various subtypes, such as diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and high-grade B-cell lymphoma.
Yescarta is an autologous CAR-T cell therapy that targets CD19. Fosun Kite acquired the technology from Kite Pharma, a subsidiary of Gilead Sciences, in 2017, and has been authorized for local production in China. The therapy modifies a patient’s T cells through genetic engineering to express chimeric antigen receptors, enabling them to target and eliminate tumor cells.
Fosun Kite previously noted that Yescarta, the therapy’s U.S. counterpart, has been approved for similar indications, marking it as the first CAR-T product licensed in Europe for treating relapsed and refractory large B-cell lymphoma and PMBCL.
In a pivotal clinical trial known as ZUMA-1, Yescarta demonstrated significant efficacy and safety in 101 adult patients with relapsed/refractory large B-cell lymphoma, achieving a median overall survival of 25.8 months and a four-year overall survival rate of 44%.
Fosun Kite submitted a new drug application for FKC876 in China in February 2020, following a bridging clinical trial that assessed its effectiveness in Chinese patients. This approval not only marks the first CAR-T cell therapy for Fosun Kite but also the first to receive marketing authorization from the NMPA.
Additionally, Kite Pharma is exploring CAR-T therapy as a first-line treatment for high-risk large B-cell lymphoma. Interim results from the ZUMA-12 trial showed that after a single infusion of Yescarta, 85% of patients responded, with 74% achieving complete remission.
At the 62nd Annual Meeting of the American Society of Hematology, Dr. Sattva S. Neelapu from the University of Texas MD Anderson Cancer Center highlighted the importance of ZUMA-12 as a groundbreaking study for using CAR-T therapy in this setting, demonstrating significant clinical benefits and manageable safety profiles.
Congratulations to Fosun Kite on this historic achievement, which offers new hope and treatment opportunities for patients in China.
