By Fineline Cube 
China’s National Medical Products Administration (NMPA) has approved Mabwell (Shanghai) Bioscience Co., Ltd’s (SHA: 688062) 8MW0511, a recombinant (yeast secreted) human serum albumin-human granulocyte colony-stimulating factor (I) fusion protein for injection. The drug is now indicated to reduce the incidence of infections manifested as febrile neutropenia (FN) in adult patients with non-myeloid malignant tumors who receive bone marrow suppressive anticancer drugs that are prone to causing febrile neutropenia.
First Homegrown G-CSF Drug in China
8MW0511 is the first homegrown G-CSF (highly active modified cytokine) drug developed in China using albumin long-acting fusion technology. This Category 1 biologic product represents a significant milestone in China’s biopharmaceutical innovation, offering a new option for patients undergoing chemotherapy.
Clinical Data and Efficacy
Phase III clinical data have demonstrated 8MW0511’s clear clinical efficacy, with non-inferiority to positive control drugs. In the trials, the drug effectively reduced the incidence of grade 4 neutropenia throughout the entire chemotherapy phase and significantly shortened the duration of grade 4 neutropenia, thereby reducing the incidence of febrile neutropenia. These results highlight the potential of 8MW0511 to improve patient outcomes and reduce complications associated with chemotherapy-induced neutropenia.-Fineline Info & Tech