Mabwell Receives NMPA Approval for Albipagrastim alfa for Injection (MAILISHENG)
Mabwell Receives NMPA Approval for Albipagrastim alfa for Injection (MAILISHENG) |
| [30-May-2025] |
SHANGHAI, May 30, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that Albipagrastim alfa for Injection (trade name: MAILISHENG, R&D code: 8MW0511) developed by its wholly-owned subsidiary T-mab has officially obtained the marketing approval by National Medical Products Administration (NMPA). MAILISHENG is Mabwell's first commercialized innovative drug, and is the first launched novel granulocyte colony-stimulating factor (G-CSF) developed with albumin long-acting fusion technology in China. Albipagrastim alfa for Injection is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Albipagrastim alfa is a new generation of long-acting G-CSF (highly active modified cytokine) with intellectual property rights of Mabwell, which was developed with albumin fusion platform technology by fusing highly active recombinant G-CSF with human serum albumin (HSA). The modification increases the molecular weight, significantly inhibits the elimination pathway mediated by G-CSF receptor and prolongs the half-life of the drug in vivo, which improves the treatment adherence by reducing the frequency of administration in clinical practice. Compared to PEG-G-CSF, Albipagrastim alfa uses HSA as its natural carrier protein via a Pichia pastoris expression system. This approach offers a simpler production process and superior product homogeneity. Mabwell previously presented results from a Phase III clinical study of 8MW0511 at the European Society for Medical Oncology (ESMO) annual meeting in 2023, and the full manuscript was published in May 2025 in Breast Cancer Research. 496 patients with breast cancer were enrolled and randomized into the study (8MW0511, n=331, control group, n=165). The result of study showed that 8MW0511 was clinically effective, non-inferior to the positive control. It is able to reduce the incidence of grade 4 neutropenia, significantly shorten the duration of grade 4 neutropenia and lower the incidence of Febrile Neutropenia (FN). The overall safety profile is similar to that of the positive control group, which indicates manageable safety profile and good tolerance in humans. The 8MW0511 group was superior to the control group in terms of the incidence of grade 4 neutropenia in cycle 1-4 of chemotherapy, the duration of grade 4 neutropenia, and the incidence of febrile neutropenia. Compared with the control group, the Absolute Risk Reduction (ARR) of grade 4 neutropenia was 3.1%, 7.0%, 4.2%, and 2.8%, while the Relative Risk Reduction (RRR) of grade 4 neutropenia was 15.6%, 68.4%, 58.3% in the 8MW0511 group during the cycle 1-4 of chemotherapy. RRR of FN was 42.0% [1]. The results of this study suggest that 8MW0511 has clinical advantages over the positive control drug, and safety advantages as a long-acting molecule using natural human proteins. The phase III clinical trial of 8MW0511 also included a chemotherapy regimen of TAC (docetaxel, doxorubicin, and cyclophosphamide), which has a high risk of FN. Stratified analysis showed that comparing to the control group, the incidence of grade 4 neutropenia in the 8MW0511 group was slightly lower during the first cycle of chemotherapy, and significantly lower during cycle 2-4 of chemotherapy.
About Neutropenia Neutropenia is a relatively common hematologic toxicity caused by chemotherapy with cytotoxic drugs, with studies showing that 65.5% of patients treated with chemotherapeutic agents such as paclitaxel, adriamycin, and cyclophosphamide experience a grade 3 or 4 decrease in their neutrophil counts. Febrile neutropenia (FN), as a clinical complication of chemotherapy, commonly results in prolonged hospitalization, increased use of broad-spectrum antibiotics and cost of therapy, reduction of chemotherapeutic agents or delayed chemotherapy, and ultimately affecting the efficacy of antitumor therapy. In more serious cases, it may lead to sepsis syndrome, infectious shock, and even death. Therefore, preventing or treating neutropenia and reducing the incidence of FN are fundamental to ensure adequate or dose-intensive chemotherapy. Globally, more than 50% of new cancer cases require chemotherapy. The number of new tumor cases in 2025 is expected to be at 5.03 million (J Natl Cancer Cent. 2024,4(1)), and the number of patients who will require the first course of chemotherapy each year from 2018 to 2040 will increase from 9.8 million (corresponding to about 50 million chemotherapy cycles) to 15 million (corresponding to about 75 million chemotherapy cycles), i.e. an increase of 53%, according to an article published in the journal The Lancet Oncology. By 2040, more than 57.7% of cancer patients worldwide are expected to require chemotherapy. In addition, with the in-depth development of basic, translational and clinical oncology research, more individualized oncology treatment, and emergence of new antitumor therapeutics, drugs for the prevention or treatment of neutropenia hold great promise for application. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 4 products have been approved and commercialized, 1 product filed for pre-NDA meeting, 2 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base in Shanghai and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit www.mabwell.com/en. Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. 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SOURCE Mabwell | |||
Company Codes: Shanghai:688062 |
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