20 December 2023 | Wednesday | News
Image Source : Public Domain
8MW0511, a Class 1 therapeutic biological product, is a new generation of long-acting G-CSF (modified cytokine with high activity) with independent intellectual property rights owned by Mabwell. 8MW0511 is produced by fusing the N-terminus of the modified G-CSF mutant gene with the C-terminus of human serum albumin with gene fusion technology. It significantly inhibits the G-CSF receptor-mediated clearance pathway, which prolongs the half-life period, reduces the frequency of drug administration, and improves the treatment compliance in clinical use. 8MW0511 is produced by yeast expression system, which brings better homogeneity, simplifies production process, and is expected to reduce the cost of production by avoiding the PEG modification reactions.
The results of the Phase III clinical study of 8MW0511 presented at the European Society for Medical Oncology (ESMO) in 2023 showed that 8MW0511 was clinically effective, non-inferior to the positive control, PEG-rhG-CSF (Jinyouli), and improved the incidence and duration of Grade 4 neutropenia, especially in cycle 2-3 where the incidence of Grade 4 neutropenia was significantly lower than that of the positive control group. The overall safety profile was similar to that of the positive control group, which indicates manageable safety profile and good tolerance in humans.