Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Mabwell has announced that its Albipagrastim alfa for Injection (Mailisheng) received marketing approval from the National Medical Products Administration (NMPA).
Albipagrastim alfa for Injection reduces the side effects of cancer chemotherapy including Neutropenia and Febrile Neutropenia. Credit: FlyD /Unsplash.
Subscribe to our email newsletter
The company’s wholly owned subsidiary T-mab developed the drug.
It is Mabwell’s first commercialised innovative drug, and the first introduced granulocyte colony-stimulating factor (G-CSF) developed with albumin long-acting fusion technology in China.
Albipagrastim alfa is indicated to decrease the incidence of infection manifested by febrile neutropenia in adults with non-myeloid malignancies undergoing myelosuppressive anti-cancer drugs associated with a clinically significant febrile neutropenia incidence.
In a Phase III clinical study involving the drug, 496 patients with breast cancer were randomised into the trial.
Results demonstrated that the drug was clinically effective and non-inferior to positive control treatments. It successfully reduced grade four neutropenia incidence while shortening its duration and lowering febrile neutropenia rates.
The overall safety profile observed was comparable to that of the positive control group, indicating manageable safety characteristics alongside good tolerance among participants.
Notably, during 1-4 cycles one through four of chemotherapy, results showed that the group which received the therapy outperformed controls regarding grade four neutropenia incidences and durations as well as febrile neutropenia occurrences.
Furthermore, the Phase III clinical trial incorporated TAC chemotherapy regimens comprising docetaxel, doxorubicin and cyclophosphamide known for their high risks related to FN development.
Stratified analyses revealed lower incidences of grade-4 neutropenia within both initial cycles compared against control groups but particularly noted reductions throughout subsequent two to four cycles when treated with the drug.
Neutropenia remains a prevalent haematologic toxicity resulting from cytotoxic chemotherapies. Studies indicate approximately 65.5% of individuals receiving agents such as paclitaxel or adriamycin experience severe drops—grade three or higher—in their neutrophil counts.
