fosun kite’s axicabtagene ciloleucel granted priority review by china nmpa
(16 march 2020, shanghai) fosun kite biotechnology (“fosun kite”) based in shanghai, a company invested by shanghai fosun pharmaceutical (group) co., ltd (“fosun pharma” or “group”; stock code: 600196.sh, 02196.hk), announced its new drug application (nda) filing for cd19-directed car-t cell therapy axicabtagene ciloleucel (fkc876) has been granted priority review status by the center for drug evaluation (cde) of china national medical products administration (nmpa), 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 pharma
founded in 1994, shanghai fosun pharmaceutical (group) co., ltd (“fosun pharma”; stock code: 600196.sh, 02196.hk) is a leading healthcare group founded in china. fosun pharma’s business covers the entire industry chain of the pharmaceutical and healthcare industry, including pharmaceutical manufacturing and r&d, healthcare services, medical devices and diagnosis, as well as pharmaceutical distribution and retail. faced with unmet medical needs, fosun pharma has established international r&d platforms in the field of innovative chemical drugs, biologics, high-value generic drugs and cell-therapy. with its commitment to innovation for good health, fosun pharma will continue insisting on the strategic development approach of “organic growth, external expansion and integrated development”, striving to be one of the leading enterprises in the global healthcare market.