SHANGHAI, China I September 28, 2023 I Mabwell (688062.SH) , an innovative biopharmaceutical company with entire industry chain, announced the first patient was dosed in a phase Ib/II trial of its novel Nectin-4 targeting ADC (R&D code: 9MW2821) in combination with PD-1 inhibitor for the treatment of locally advanced or metastatic urothelial carcinoma.

The clinical trial (CTR20232677) is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetic profile of 9MW2821 in combination with PD-1 inhibitor in patients with locally advanced or metastatic urothelial carcinoma.

About 9MW2821

9MW2821 is a novel Nectin-4 targeting ADC developed by world-class ADC development platform and automated high-throughput antibody discovery platform of Mabwell. It achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process. 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells.

9MW2821 boasts the advantages of homogenous composition, higher purity and it is suitable for industrial scale-up. The preliminary data show positive therapeutic signals in solid tumors, and good safety profile at the recommended phase II dose (RP2D). Mabwell is promoting the enrollment of multiple cohorts of UC, CC, prostate cancer, HER-2 negative breast cancer, and non-small cell lung cancer. The R&D progress of 9MW2821 ranks first in China and second in the world. 9MW2821 is the first to receive preliminary clinical data in cervical cancer among the drug candidates with the same target in the world. Phased data will be published on ESMO Congress 2023.

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, 1 product has been filed for MA approval, 1 product is in the preparation of filing, 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 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 .

SOURCE: Mabwell