Gelonghui, March 1 | Keji Pharmaceutical-B (02171.HK) announced that the National Drug Administration (“NMPA”) has officially approved the new drug marketing application (“NDA”) of Saekaize (Zevokiolensis injection, product number: CT053, an autologous CAR-T candidate for BCMA) to treat adult patients with recurrent or refractory multiple myeloma, progressed after at least 3 lines of treatment (at least one proteasome inhibitor and immunomodulator).
Cykaize is an autologous BCMA-targeted CAR-T cell product. It is produced by lentivirus transduction of T cells. The CAR encoded by lentivirus includes an all-human BCMA-specific single-chain variable fragment (“scFv”), a human CD8α hinge domain, a CD8α transmembrane domain, a 4-1 BB co-stimulation domain, and a CD3zeta activation domain. Self-developed new whole-human scFv has high binding affinity and stability.
Sikaize's approval was based on an open-label, single-arm, multi-center phase II clinical trial (LUMMICAR STUDY 1, NCT03975907) conducted in China. According to test results published by the American Society of Hematology (“ASH”) in 2022, Seckeiser has shown encouraging efficacy and good safety.
Multiple myeloma is an intractable malignant plasmacytic disease that accounts for about 10% of all hematologic tumors. As China's aging accelerates and the average life expectancy of the population increases, it is expected that the number of cases of multiple myeloma will continue to increase. According to Frost and Sullivan estimates, the number of cases of multiple myeloma in China in 2023 is about 153,000, and the number of new cases is 23,200. The number of cases of multiple myeloma in China is expected to increase to 266,300 in 2030.