NMPA Approves Review of Mabwell’s Injectable Drug 8MW0511 for Examination

Mabwell, a pioneering company in the biopharmaceutical sector with comprehensive industry chain capabilities, has publicized the acceptance of its investigational new drug filing by the National Medical Products Administration. The drug, a novel recombinant fusion protein that combines human serum albumin with human granulocyte colony-stimulating factor, is designed for injectable use and is identified by its research and development code: 8MW0511.

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The therapeutic agent 8MW0511 has been formulated for adult patients facing non-myeloid cancerous growths, aiming to diminish the potential for infection occurrences characterized by fever and a significant reduction in neutrophil count. This condition can arise following the administration of certain chemotherapeutic agents known to suppress bone marrow activity and predispose patients to febrile neutropenia.

Structured as a primary category biological therapeutic compound, 8MW0511 is a novel, extended-duration form of G-CSF created by Mabwell, a company holding proprietary rights to its formulation. The production methodology for 8MW0511 involves a pioneering combination of a G-CSF variable non-homologous with an endogenous protein - human serum albumin - using advanced genetic bonding mechanisms. This innovative approach notably hinders the normal route of receptor-driven elimination specific to G-CSF, thereby extending its biological half-life, cutting down the necessity for frequent dosages, and enhancing patient adherence during treatments.

Utilizing a sophisticated yeast-based bioprocessing system, the production of 8MW0511 achieves a higher consistency in its output, streamlines the manufacturing workflow, and is anticipated to bring down overall expenditure by circumventing the need for polyethylene glycol (PEG) based modifications.

Clinical findings from a Phase III trial, unveiled at the European Society for Medical Oncology conference in 2023, affirm the efficacy of 8MW0511 as being on par with the benchmark treatment with PEG-rhG-CSF. Considerable improvements in the rate and severity of Grade 4 neutropenia were observed. The treatment's safety spectrum was reported to be agreeable and akin to that of the comparator group, denoting a well-regulated safety aspect and favorable patient tolerance levels.

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According to the data provided by the Synapse Database, As of December 28, 2023, there are 181 investigational drugs for the CSF-3R target, including 73 indications, 205 R&D institutions involved, with related clinical trials reaching 1519, and as many as 1347 patents.

8MW0511 is a cytokine fusion protein and biosimilar that targets the CSF-3R receptor. It is primarily used for the treatment of hemic and lymphatic diseases, specifically neutropenia and leukopenia. The drug is currently in the highest phase of development, NDA/BLA, both globally and in China, indicating its advanced stage of development.