SHANGHAI, Feb. 21, 2024 /PRNewswire/ — Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, recently published the phase III study results of denosumab biosimilar (MW032) online in the international top journal of JAMA Oncology. This is the first recorded trial to systematically compare the efficacy, population pharmacokinetics, and safety profile of MW032 and reference denosumab in patients with solid tumors with bone metastasis through a 53-week, multicenter, randomized, double-blind, phase 3 equivalence trial.
708 eligible patients were enrolled and randomly assigned (1:1) to receive MW032 or reference denosumab subcutaneously every 4 weeks until week 49. The primary end point was percentage change from baseline to week 13 of natural logarithmic transformed urinary N-telopeptide/creatinine ratio (uNTx/uCr). Secondary end points were percentage change in uNTx/uCr and bone-specific alkaline phosphatase (s-BALP) from baseline to weeks 5, 13, 25, 37, and 53, and the incidence of SREs.
The results showed that the mean change of uNTx/uCr from baseline to week 13 was −72.0% in the MW032 group and −72.7% in the control group. After adjusting for stratification factors, the LSM (least squares mean) difference of these logarithmic transformed percent changes was 0.02. The 90% CI for the difference (−0.04 to 0.09) was within the equivalence margin. Sensitivity analyses of the primary end point, subgroup analysis, and secondary end points analysis demonstrated similarity in efficacy between the two treatment groups.
705 patients receiving at least 1 dose of investigational therapy were included in the safety analyses. The incidence of adverse events (AE), treatment related AEs, and AEs leading to discontinuation were similar in the MW032 and control groups. Treatment related AEs with the highest incidence were hypocalcemia, hypophosphatemia, and hyperuricemia, which occurred at similar rates in both treatment groups. Similarity study of immunogenicity and population pharmacokinetics have been conducted in the study.
The study systematically demonstrated that MW032 and denosumab were biosimilar in efficacy, safety profile and population pharmacokinetics. Launch of MW032 will broaden patient access to denosumab, reduce financial burden on patients, and finally benefit more patients with advanced tumors.
Find paper at: https://jamanetwork.com/journals/jamaoncology/fullarticle/2814859
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 products have 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.
>
This content was prepared by our news partner, Cision PR Newswire. The opinions and the content published on this page are the author’s own and do not necessarily reflect the views of Siam News Network
