Pharma Focus Asia

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

Wednesday, December 20, 2023

Mabwell (stock code: 688062.SH) 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.



magazine-slider-imageMFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024Advance DoE WorkshopNitrosamine Advance Workshop 2024CPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024Rehab Expo 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024LogiPharma Asia 2024