SHANGHAI, China I April 2, 2025 I Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel B7-H3-targeting ADC (R&D code: 7MW3711) has been approved by the NMPA to enter Phase Ib/II clinical trial in combination with a PD-1 Inhibitor, with or without antitumor therapies, for the treatment of advanced solid tumors.
7MW3711 is developed by Mabwell’s Interchain-Disulfide Drug Conjugate (IDDC™) platform and is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. The approved phase Ib/II clinical trial aims to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetic profile of 7MW3711 in combination with a PD-1 inhibitor, with or without antitumor therapies, in patients with advanced solid tumors. Previously, 7MW3711 has been approved for clinical studies in advanced solid tumors by the NMPA and the FDA, respectively, and was granted orphan drug designation (ODD) by the FDA for the treatment of small cell lung cancer.
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 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for market 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 multiple 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 in Shanghai and the ADC commercialized manufacturing base in Taizhou are 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/en.
SOURCE: Mabwell
Post Views: 855
SHANGHAI, China I April 2, 2025 I Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel B7-H3-targeting ADC (R&D code: 7MW3711) has been approved by the NMPA to enter Phase Ib/II clinical trial in combination with a PD-1 Inhibitor, with or without antitumor therapies, for the treatment of advanced solid tumors.
7MW3711 is developed by Mabwell’s Interchain-Disulfide Drug Conjugate (IDDC™) platform and is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. The approved phase Ib/II clinical trial aims to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetic profile of 7MW3711 in combination with a PD-1 inhibitor, with or without antitumor therapies, in patients with advanced solid tumors. Previously, 7MW3711 has been approved for clinical studies in advanced solid tumors by the NMPA and the FDA, respectively, and was granted orphan drug designation (ODD) by the FDA for the treatment of small cell lung cancer.
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 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for market 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 multiple 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 in Shanghai and the ADC commercialized manufacturing base in Taizhou are 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/en.
SOURCE: Mabwell
Post Views: 855
