By Fineline Cube 
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its B7-H3 directed antibody drug conjugate (ADC), 7MW3711. The approval allows the company to proceed with a Phase Ib/II study evaluating the drug in combination with a PD-1 inhibitor, with or without additional anti-tumor therapy, for advanced solid tumors.
Clinical Trial Objectives
The Phase Ib/II study will assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of 7MW3711. This approval marks a significant step forward in the development of the drug, which has shown promise in preclinical studies.
Regulatory and Development Milestones
7MW3711 has previously been granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of small cell lung cancer. The drug has also received clinical approvals for advanced solid tumors in both China and the US, highlighting its potential to address significant unmet medical needs.-Fineline Info & Tech