Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that the new drug application of its recombinant (yeast-secreted) human serum albumin-human granulocyte colony-stimulating factor (I) fusion protein for injection (R&D code: 8MW0511) has been accepted by the National Medical Products Administration (NMPA).
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| [19-December-2023] |
| SHANGHAI, Dec. 19, 2023 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that the new drug application of its recombinant (yeast-secreted) human serum albumin-human granulocyte colony-stimulating factor (I) fusion protein for injection (R&D code: 8MW0511) has been accepted by the National Medical Products Administration (NMPA) for use in adult patients with non-myeloid malignant neoplasms to reduce the incidence of infections manifested by febrile neutropenia when receiving myelosuppressive anticancer drugs that are susceptible to febrile neutropenia. 8MW0511, a Class 1 therapeutic biological product, is a new generation of long-acting G-CSF (modified cytokine with high activity) with independent intellectual property rights owned by Mabwell. 8MW0511 is produced by fusing the N-terminus of the modified G-CSF mutant gene with the C-terminus of human serum albumin with gene fusion technology. It significantly inhibits the G-CSF receptor-mediated clearance pathway, which prolongs the half-life period, reduces the frequency of drug administration, and improves the treatment compliance in clinical use. 8MW0511 is produced by yeast expression system, which brings better homogeneity, simplifies production process, and is expected to reduce the cost of production by avoiding the PEG modification reactions. The results of the Phase III clinical study of 8MW0511 presented at the European Society for Medical Oncology (ESMO) in 2023 showed that 8MW0511 was clinically effective, non-inferior to the positive control, PEG-rhG-CSF (Jinyouli), and improved the incidence and duration of Grade 4 neutropenia, especially in cycle 2-3 where the incidence of Grade 4 neutropenia was significantly lower than that of the positive control group. The overall safety profile was similar to that of the positive control group, which indicates manageable safety profile and good tolerance in humans. 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 14 pipeline products in different R&D stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 2 products have been approved and commercialized, 2 product has been filed for MA approval, 3 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 several 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 located in Shanghai is 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. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would,” and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company’s current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company’s control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement.
SOURCE Mabwell | ||
Company Codes: Shanghai:688062 |
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