Mabwell Announces NMPA Approval to Initiate Clinical Trial of novel B7-H3-targeting ADC for Advanced Solid Tumors in Combination with PD-1 Inhibitor

Release time:Apr 02, 2025

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.