Mabwell 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 inhibitors in patients with locally advanced or metastatic urosthelial carcinoma. 9MW2821 is a novel Nectin-4 targeted 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 reduce 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 has 14 pipeline products in different R&D stages based on a 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, 1 product has been filed for MA approval, 1 product is in the preparation of filing, 2 products are in pivotal trials. The company have also undertaken 1 national major scientific and technological special project for "Sign 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.