Phase III Results: Mabwell's Denosumab Biosimilar (MW032) Published in JAMA Oncology

Mabwell, a biopharmaceutical firm, has published findings from a phase III clinical trial of its denosumab biosimilar, MW032, in JAMA Oncology. The study was a first of its kind, conducting a 53-week, multicenter, randomized, double-blind trial to compare the efficacy, population pharmacokinetics, and safety of MW032 with the original denosumab in patients with solid tumors that have metastasized to the bone.

The trial involved 708 eligible participants who were given either MW032 or the reference drug subcutaneously every four weeks until the 49th week. The primary outcome measured was the percentage change from baseline to the 13th week in the urinary N-telopeptide/creatinine ratio (uNTx/uCr), a marker of bone resorption. Secondary outcomes included changes in uNTx/uCr and bone-specific alkaline phosphatase (s-BALP) at various time points and the occurrence of skeletal-related events (SREs).

Results indicated that MW032 was comparable to the control group in terms of uNTx/uCr percentage change, with a mean change from baseline to week 13 of -72.0% for MW032 and -72.7% for the control group. After adjusting for stratification factors, the least squares mean difference was 0.02, and the 90% confidence interval for the difference was within the set equivalence margin. Sensitivity and subgroup analyses, along with secondary endpoints, also pointed to similar efficacy for both treatment groups.

Safety analysis included 705 patients who received at least one dose of the therapy. The incidence of adverse events, treatment-related adverse events, and events leading to discontinuation was similar between MW032 and the control group. The most common treatment-related adverse events were hypocalcemia, hypophosphatemia, and hyperuricemia, occurring at comparable rates in both groups. The study also included assessments of immunogenicity and population pharmacokinetics.

The research concluded that MW032 is biosimilar to denosumab in terms of efficacy, safety, and pharmacokinetics. The introduction of MW032 is expected to increase patient access to this class of drugs, reduce financial strain, and ultimately benefit more patients with advanced tumors.

Mabwell, listed on the stock exchange (688062.SH), is an innovation-driven biopharmaceutical company that has developed an extensive R&D system since 2017. The company has a diverse pipeline of 14 products in various stages of development, including 10 novel drug candidates and 4 biosimilars. Mabwell focuses on several therapeutic areas, with two products already commercialized and others in the approval process or pivotal trials. They also participate in significant national and regional scientific and technological innovation projects. The company's Taizhou factory adheres to international GMP standards and is currently constructing a large-scale manufacturing base in Shanghai. Mabwell is guided by a mission to explore life and benefit health, with a vision driven by innovation from concept to reality.