China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its subsidiary Fosun Kite Biotechnology Co., Ltd’s chimeric antigen receptor (CAR)-T cell therapy FKC889 has obtained clinical trial approval in mainland China to treat adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL).
Drug Profile and Development
FKC889 is a localized version of US major Gilead’s subsidiary Kite Pharma, Inc.’s Tecartus (brexucabtagene autoleucel), an anti-CD19 CAR-T therapy which obtained market approvals in the US and Europe in July 2020 and December 2020 respectively. In February of this year, FKC889 was approved for study as a second-line or later therapy in relapsed or refractory mantle cell lymphoma (r/r MCL) in mainland China, with that trial currently at the bridging phase.
Acute Lymphoblastic Leukemia and Treatment Landscape
Acute lymphoblastic leukemia (ALL) is a common malignant hematological disease, with precursor B-cell ALL being the most common form, accounting for about 75%. Currently, in addition to traditional chemotherapy and hematopoietic stem cell transplantation, many new ALL therapies have been approved worldwide. These include Novartis’s Gleevec/Glivec (imatinib), BMS’s Sprycel (dasatinib), and Takeda’s Iclusig (ponatinib), all tyrosine kinase inhibitors. Amgen’s Blincyto is a CD19-CD3 bispecific immunotherapy, Pfizer’s Besponsa is a CD22 targeted ADC, and Novartis’ Kymriah is a CD19 targeted autologous CAR-T therapy. Unlike Tecartus, Kymriah is approved for the treatment of patients with B-cell r/r ALL aged 25 years and younger.
Future Prospects and Strategic Implications
The clinical trial approval for FKC889 in mainland China positions Fosun Kite to further advance its CAR-T therapy in addressing significant unmet medical needs in the treatment of acute lymphoblastic leukemia. This move underscores Fosun Pharmaceutical’s commitment to innovation and improving patient outcomes through advanced therapeutic solutions.-Fineline Info & Tech
