Mabwell Gains NMPA Approval for Albipagrastim Alfa for Injection (MAILISHENG)
Saturday, May 31, 2025
Mabwell (688062.SH), an innovation-focused biopharmaceutical company, has received marketing approval from the National Medical Products Administration (NMPA) in China for Albipagrastim alfa for Injection, marketed under the trade name MAILISHENG. The drug, developed by Mabwell’s fully owned subsidiary T-mab, is the company’s first approved innovative medicine and the first granulocyte colony-stimulating factor (G-CSF) in China developed using albumin-based long-acting fusion technology.
Albipagrastim alfa is intended to reduce the risk of infections caused by febrile neutropenia in adults with non-myeloid cancers who are receiving chemotherapy that lowers white blood cell counts. The drug is a next-generation long-acting G-CSF developed using Mabwell’s proprietary albumin fusion platform, which combines recombinant G-CSF with human serum albumin (HSA). This modification increases the molecular size, slows down drug clearance via G-CSF receptor pathways, and extends the drug’s half-life. As a result, the frequency of injections can be reduced, improving patient compliance.
Unlike traditional PEGylated G-CSFs, Albipagrastim alfa uses HSA as a natural carrier and is produced using a Pichia pastoris expression system. This method allows for a simpler manufacturing process and better product consistency.
The approval is supported by data from a Phase III clinical trial involving 496 breast cancer patients, presented at the 2023 ESMO Annual Meeting and published in Breast Cancer Research in May 2025. In this study, 331 patients received Albipagrastim alfa (8MW0511), while 165 patients were placed in the control group. The results showed that 8MW0511 was clinically effective and not inferior to the comparator. It significantly reduced the incidence and duration of grade 4 neutropenia and lowered the risk of febrile neutropenia (FN), with a safety profile comparable to that of the control.
Further analysis showed that Albipagrastim alfa had clear advantages in multiple chemotherapy cycles (1–4). The absolute risk reduction (ARR) for grade 4 neutropenia across these cycles was 3.1%, 7.0%, 4.2%, and 2.8%, while the relative risk reduction (RRR) reached up to 68.4% in some cycles. The RRR for febrile neutropenia was 42.0%.
The study also included a TAC chemotherapy regimen (docetaxel, doxorubicin, cyclophosphamide), known to carry a high risk of FN. In this subgroup, Albipagrastim alfa demonstrated a slightly lower rate of grade 4 neutropenia in the first cycle and a significantly lower rate in cycles 2 to 4, compared to the control.
These results support the clinical value and safety profile of Albipagrastim alfa as a long-acting treatment based on human protein technology, offering a promising option for patients undergoing chemotherapy.
Source: prnewswire.com
