Mabwell Announces the NMPA Approval of Novel B7-H3 ADC (7MW3711) for IND

SHANGHAI, July 21, 2023 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its clinical trial application of 7MW3711 for advanced malignant solid tumor was approved by the National Medical Products Administration (NMPA). 7MW3711 is developed by Mabwell's next-generation antibody-drug conjugate platform IDDC™.

B7-H3 is a member of the B7 ligand family and is overexpressed in most cancer types but expressed at a low level in normal tissues. In malignant tissues, B7-H3 inhibits tumor antigen-specific immune responses, resulting in a protumorigenic effect. Additionally, B7-H3 promotes migration and invasion, angiogenesis, chemotherapy resistance, endothelial-to-mesenchymal transition, and affects tumor cell metabolism.

The next generation antibody-drug conjugate molecule 7MW3711 with proprietary intellectual property right, developed by Mabwell's next-generation antibody-drug conjugate platform IDDC™, is composed of innovative antibody molecule, novel linker, and novel payload (topoisomerase I inhibitor). When 7MW3711 enters human body, it specifically binds to antigens on the tumor cell membrane surface, be internalized and transferred to the lysosome, release cytotoxic drug, and induce the apoptosis of tumor cells.

7MW3711 is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. Compared with drugs in the same class at home and abroad, 7MW3711 has shown better tumor killing effects in multiple animal tumor models. In the safety evaluation model of animals including cynomolgus monkeys, the on-target and off-target toxicities of 7MW3711 are effectively controlled, showing its good safety profile and pharmacokinetic properties. The above research results indicate that 7MW3711 has clinical differentiation characteristics and a promising future of clinical development.

Next generation antibody-drug conjugate platform IDDC™

Mabwell has developed multiple ADC technology platforms, and its Nectin-4-targeting ADC (R&D code: 9MW2821) is currently in the phase II clinical study.

IDDC™ is a next generation ADC site-specific conjugate technology platform independently developed by Mabwell. It is composed of multiple systematized core patent technologies including site-specific conjugate process DARfinity™, special designed linker IDconnect™, novel payload Mtoxin™, and conditional release structure LysOnly™, which improves structural homogeneity, quality stability, pharmacodynamics and tolerability of the ADC products.

Currently, the advantage of the IDDC™ platform has been validated in several products under development. Trop-2-targeting ADC (R&D code: 9MW2921) has been approved for clinical study in advanced solid tumor. It is expected multiple ADC products will enter clinical development in 2023 and 2024.

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 auto-immune diseases, oncology, 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, 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.

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SOURCE Mabwell