NMPA Approves Mabwell's New Drug Application for 8MW0511 Injection

Mabwell is an innovative biopharmaceutical company boasting a comprehensive industry chain. Recently, the National Medical Products Administration (NMPA) accepted the new drug application for its recombinant (yeast-secreted) human serum albumin-human granulocyte colony-stimulating factor (G-CSF) fusion protein for injection (R&D code: 8MW0511). This application targets adult patients with non-myeloid malignant neoplasms, aiming to reduce infections manifested by febrile neutropenia during myelosuppressive anticancer treatments.

8MW0511, classified as a Class 1 therapeutic biological product, represents a new generation of long-acting G-CSF with Mabwell's independent intellectual property rights. The drug is produced through gene fusion technology, fusing the N-terminus of the modified G-CSF mutant gene with the C-terminus of human serum albumin. This innovative method inhibits the G-CSF receptor-mediated clearance pathway, leading to a prolonged half-life, reduced administration frequency, and improved treatment compliance. The yeast expression system used for production enhances homogeneity, simplifies the production process, and is expected to reduce costs by eliminating PEG modification reactions.

The Phase III clinical study results for 8MW0511, presented at the 2023 European Society for Medical Oncology (ESMO) conference, demonstrated its clinical effectiveness. It proved non-inferior to the positive control, PEG-rhG-CSF (Jinyouli), and exhibited improvements in the incidence and duration of Grade 4 neutropenia, especially in cycles 2-3, where the incidence of Grade 4 neutropenia was significantly lower than that of the positive control group. The overall safety profile was comparable to the positive control group, indicating a manageable safety profile and good human tolerance.

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