#China #Shanghai #Mabwell #Albipagrastim #MAILISHENG

Mabwell Achieves NMPA Approval for Albipagrastim alfa Injection

Mabwell, a pioneering biopharmaceutical enterprise, recently celebrated a major milestone with the National Medical Products Administration's (NMPA) approval of their innovative treatment, Albipagrastim alfa for Injection. Marketed under the trade name MAILISHENG, this breakthrough medication represents the first-of-its-kind granulocyte colony-stimulating factor (G-CSF) in China, developed utilizing albumin long-acting fusion technology.

Albipagrastim alfa is designed to mitigate the risk of febrile neutropenia in adults undergoing myelosuppressive chemotherapy for non-myeloid malignancies. Febrile neutropenia is a significant complication of cancer treatment, resulting in elevated infection rates, extended hospital stays, and the potential need for broad-spectrum antibiotics, all of which could compromise the effectiveness of antitumor therapies.

Innovative Development

Mabwell's Albipagrastim alfa is a next-generation, long-acting G-CSF that has been developed using a unique albumin fusion platform. This innovative approach enhances the drug's molecular weight and improves its pharmacokinetic properties, effectively increasing its half-life in the body. Consequently, patients may experience increased treatment adherence due to a reduced frequency of administration compared to existing therapies.

In clinical studies, Albipagrastim alfa demonstrated impressive results, showcasing its ability to significantly lower the incidence of severe neutropenia and shorten its duration. Such results were presented at the prestigious European Society for Medical Oncology (ESMO) meeting in 2023 and were further elaborated upon in a full manuscript published in May 2025 in Breast Cancer Research.

A comprehensive Phase III clinical trial involved 496 breast cancer patients, with outcomes showing that Albipagrastim alfa outperformed the control group in several key metrics. Notably, there was a 15.6% relative risk reduction in grade 4 neutropenia during chemotherapy cycles, demonstrating the drug's potential effectiveness.

Impact on Patients and Healthcare

Neutropenia, particularly febrile neutropenia, affects a significant portion of cancer patients undergoing chemotherapy. With projections showing that more than 50% of new cancer diagnoses will require chemotherapy by 2025, addressing complications associated with treatment is imperative. Albipagrastim alfa’s approval thus represents a meaningful advancement in patient care, potentially enhancing the quality and effectiveness of cancer treatments.

Mabwell's proactive approach in developing drugs like Albipagrastim alfa reflects a commitment to innovation and addressing global healthcare needs. This approval lays the groundwork for further development and expansion of their product portfolio, with a diverse pipeline of other therapeutic agents also in various stages of research and development.

About Mabwell

Founded in 2017, Mabwell operates with a clear mission to explore life and benefit health through innovative biopharmaceutical solutions. The company distinguishes itself with its comprehensive R&D framework, focusing on critical therapeutic areas such as oncology, immunology, and hematology. To date, Mabwell has successfully brought several products to market, solidifying its position as a leader in the biopharmaceutical space.

With Albipagrastim alfa now part of Mabwell's offerings, the future looks promising, as the company continues to push the boundaries of medical innovation and provide effective therapies for cancer patients worldwide.