Chinese biopharmaceutical company Mabwell (SH:688062) announced on Wednesday that China's National Medical Products Administration (NMPA) has approved the company's novel B7-H3-targeting ADC (R&D code: 7MW3711) for a Phase Ib/II clinical trial in combination with a PD-1 inhibitor, with or without anti-tumour therapies, for the treatment of advanced solid tumours.

7MW3711 was developed using Mabwell's Interchain-Disulfide Drug Conjugate (IDDC) platform. It is designed to have a stable structure, homogeneous composition, high purity, and to be suitable for industrial scale-up.

The approved Phase Ib/II clinical trial is intended to assess the safety, tolerability, preliminary efficacy and pharmacokinetic profile of 7MW3711 along with a PD-1 inhibitor, with or without anti-tumour therapies, in patients with advanced solid tumours. Previously, 7MW3711 was approved for clinical studies in advanced solid tumours by the NMPA and the FDA, and was granted orphan drug designation (ODD) by the FDA for the treatment of small cell lung cancer.