New Drug Application (NDA) Filing for Axicabtagene Ciloleucel has been granted priority review status
(Shanghai, China) Today, Fosun Kite Biotechnology based in Shanghai announced its New Drug Application (NDA) filing Axicabtagene Ciloleucel (FKC876) has been granted priority review status by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) further to its NDA filing acceptance, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
Axicabtagene Ciloleucel, FKC876, is an autologous CD19-directed CAR-T cell therapy manufactured in China with the technology of YESCARTA®(Axicabtagene Ciloleucel) transferred from Kite Pharma, a Gilead company.
Richard Wang, CEO of Fosun Kite Biotechnology, commented, “We are very pleased to see Axicabtagene Ciloleucel been granted a priority review by NMPA, further to its NDA filing acceptance as the first for any CAR-T product in China so far. We are also very grateful to China regulatory authorities for the priority review mechanism to accelerate innovation drug approval for unmet medical needs, and to their preliminary recognition of Axicabtagene Ciloleucel as a cutting-edge technology and potential clinical benefits. Under the priority review, we hope to get timely feedback and guidance from NMPA, which will help move Axicabtagene Ciloleucel forward to benefit lymphoma patients in China.”
In 2017 Fosun Kite initiated the technology transfer of the world’s first approved CAR-T cell therapy for adult NHL - YESCARTA®(Axicabtagene Ciloleucel) from Kite Pharma, named FKC876 in China, and obtained full technical and commercial rights in mainland China, Hong Kong SAR and Macau SAR. In August 2018, FKC876 obtained the Investigational New Drug (IND) approval from China NMPA, and completed a bridging clinical trial in September 2019 in support of its marketing registration in China. In December 2019, Fosun Kite opened an approx. 10,000 sqm commercial manufacturing facility in the Zhangjiang Innovative Medicine Industrialization Park in preparation for commercial production of FKC876 upon approval.
About Fosun Kite
As a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd and Kite Pharma (a Gilead company) in the U.S., Fosun Kite is dedicated to the advancement and commercialization of innovative immune cell therapies in China to benefit patients. Since establishment in 2017, Fosun Kite has brought in the technology of YESCARTA®(Axicabtagene Ciloleucel), the world’s first approved CAR-T cell therapy for NHL, from Kite Pharma for development in China (named FKC876), built a GMP manufacturing site for clinical studies, obtained the Investigational New Drug (IND) approval and completed its registrational clinical studies in China. Headquartered in Zhangjiang Hi-tech Park of Shanghai, Fosun Kite opened an approx. 10,000 sqm commercial manufacturing facility in Zhangjiang Innovative Medicine Industrialization Park in December 2019. Meanwhile, Fosun Kite has also built a 2000 sqm R&D center and a professionally talented and experienced R&D team, taking a combined approach of internal R&D effort and external partnering to build a sustainable pipeline including CAR-T/TCR-T programs in both discovery and clinical stages.
For more information, please visit www.fosunkitebio.com.