Mabwell Announces the NMPA Approval of Novel Trop-2 ADC (9MW2921) for IND
SHANGHAI,July 19,2023 -- Mabwell (688062.SH),an innovative biopharmaceutical company with entire industry chain,announced that its clinical trial application of 9MW2921 for advanced solid tumor was approved by the National Medical Products Administration (NMPA). 9MW2921 is developed by Mabwell's novel antibody-drug conjugate platform IDDC™.
9MW2921 is a next generation antibody-drug conjugate (ADC) developed by Mabwell based on IDDC™ (Interchain-Disulfide Drug Conjugate) platform for the treatment of solid tumors. It is an innovative antibody molecule linked to a novel payload (TOP1i) by a novel linker with fully autonomous intellectual property right. When 9MW2921 enters the body,it can specifically bind to antigens on the cell membrane surface,be internalized and transferred to the lysosome,release cytotoxic drug,and induce the apoptosis of tumor cells.
9MW2921 is pharmaceutical characterized as stable structure,homogeneous composition,high purity,and it is suitable for industrial scale-up. Compared with ADCs of the same class under development at home and abroad,9MW2921 is significantly improved and optimized in endocytic activity,plasma stability,drug release characteristics,bystander killing effect,etc. In vivo pharmacodynamic studies demonstrated that 9MW2921 had a better tumor killing activity. In animal safety evaluation models including cynomolgus monkeys and rats,the on-target and off-target toxicities of 9MW2921 were effectively controlled,indicating that 9MW2921 has good safety profile and pharmacokinetic properties.
Belonging to the TACSTD family,Trop-2 is a cell surface glycoprotein encoded by the TACSTD gene. It is expressed in normal tissues at low levels,while overexpressed in multiple malignant tumors. Trop-2 expression correlates with tumor aggressiveness. Trop-2 overexpression promotes the growth,proliferation,and metastasis of tumor cells.
Next generation antibody-drug conjugate platform IDDC™
Mabwell has developed multiple ADC technology platforms,and its anti-Nectin-4 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™.
The next generation ADCs developed based on the above systematic patent technologies will carry better structural homogeneity,quality stability,pharmacodynamics and tolerability. Currently,the IDDC™ platform has been validated in several products under development. 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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