Mabwell Bioscience Receives NMPA Approval for 6MW3511 Clinical Trial in Solid Tumors

China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that the National Medical Products Administration (NMPA) has approved a clinical trial for its drug candidate 6MW3511, targeting advanced solid tumors. The trial will evaluate the drug’s efficacy and safety in patients with advanced solid tumors.

Drug Profile
6MW3511 is a bifunctional protein composed of humanized anti-PD-L1 nanobodies linked to TGF-β RII mutants. The design aims to enhance stability and reduce degradation of the native TGF-β RII group during production and in vivo. By blocking both PD-1/PD-L1 and TGF-β/TGF-β-R pathways, 6MW3511 is expected to overcome immunosuppression in the tumor microenvironment. Its compact structure allows for improved tumor penetration.

Preclinical Results
Preclinical studies demonstrated that 6MW3511 exhibited robust antitumor efficacy and good tolerance in animal models, with minimal off-target toxicity. The drug’s dual-targeting mechanism positions it as a promising candidate for solid tumor therapy.

Clinical Trial Details
The upcoming trial will assess 6MW3511’s safety, tolerability, and preliminary efficacy in patients with advanced solid tumors. The study builds on preclinical data and aims to advance the drug toward potential regulatory approvals.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry