Mabwell 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.

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 R&D engine, including 10 novel drug candidates and 4 biosimilars. The company 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. The company 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.