Mabwell Secures NMPA Approval for MAILISHENG (Albipagrastim alfa for Injection)
Saturday, May 31, 2025
Mabwell has received marketing approval from the National Medical Products Administration (NMPA) in China for its new drug Albipagrastim alfa for Injection (MAILISHENG).
MAILISHENG is the first novel granulocyte colony-stimulating factor (G-CSF) in China developed using albumin-based long-acting fusion technology. It is intended to lower the risk of infection particularly febrile neutropenia in adult patients with non-myeloid cancers undergoing chemotherapy known to cause this condition.
Albipagrastim alfa is a next-generation long-acting G-CSF created using Mabwell’s proprietary albumin fusion platform. It combines a highly active form of recombinant G-CSF with human serum albumin (HSA), increasing the molecular weight and slowing down its clearance from the body.
This modification extends the drug’s half-life, helping to reduce how often it needs to be administered. Unlike PEGylated G-CSFs, Albipagrastim alfa uses HSA as a natural carrier and is produced via the Pichia pastoris expression system, which allows for a more straightforward manufacturing process and consistent product quality.
Neutropenia is a common side effect of chemotherapy, often seen in patients treated with drugs such as paclitaxel, adriamycin, and cyclophosphamide. It involves a marked reduction in neutrophil counts and can lead to febrile neutropenia a serious condition that increases hospital stays, antibiotic use, and treatment costs. It can also cause delays or dose reductions in chemotherapy, which may affect the success of cancer treatment.
In severe cases, FN can progress to sepsis or even death. As a result, managing neutropenia is essential to ensure safe and effective cancer therapy.
Developed by Mabwell’s wholly owned subsidiary, T-mab, this marks the company’s first approved innovative product.
The trial also included the TAC chemotherapy regimen (docetaxel, doxorubicin, and cyclophosphamide), known for its high risk of FN. A stratified analysis showed that Albipagrastim alfa performed better than the control in later chemotherapy cycles, particularly from the second cycle onwards.
Source: mabwell.com
