Zelgen Biopharmaceuticals’ ZGGS18 Receives NMPA Approval for Solid Tumor Treatment

China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate ZGGS18. The molecule will be assessed as a treatment for general advanced solid tumors.

Drug Details
ZGGS18 is a bispecific antibody (BsAb) targeting vascular endothelial growth factor (VEGF) and transforming growth factor-beta (TGF-β). The molecule is designed to produce a synergistic effect, inhibiting tumor growth and reducing tumor metastasis while improving and regulating the tumor microenvironment. ZGGS18 is expected to be used in combination with programmed death-(ligand) 1 (PD-1/L1) inhibitors, as well as Zelgen’s pipeline drug ZG005, a PD-1/TIGIT BsAb.

Preclinical Results
Preclinical studies show that ZGGS18 is capable of significant tumor inhibitory effects in human non-small cell lung cancer, colorectal cancer, and other models. After combined treatment with an anti-PD-1 antibody, it caused a significant proportion of tumor cells in mouse models to completely subside. This indicates that it has a strong tumor-killing effect and the potential to enhance the efficacy of tumor immunotherapy drugs. In non-human primates, ZGGS18 showed good pharmacokinetic characteristics such as a long half-life and good safety characteristics. The drug obtained trial approval in the US in July this year to treat advanced solid tumors.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry