By Fineline Cube 
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that the U.S. Food and Drug Administration (FDA) has approved a clinical trial combining its novel bispecific antibody ZG005 with the bifunctional fusion protein ZGGS18 for the treatment of advanced solid tumors.
What the Trial Entails
- ZG005 is a recombinant humanized anti‑PD‑1/TIGIT bispecific antibody (BsAb). It represents a Category 1 therapeutic biologic for tumor immunotherapy and is the first drug of its kind with this dual checkpoint blockade mechanism to receive FDA clearance.
- ZGGS18 is a recombinant humanized anti‑VEGF/TGF‑β bifunctional antibody fusion protein, also a Category 1 therapeutic biologic. It targets tumor angiogenesis while modulating the tumor microenvironment to enhance immune infiltration.
The combination aims to simultaneously unleash T‑cell activity and disrupt the tumor vasculature, potentially overcoming resistance seen with single‑target agents.
Significance for Suzhou Zelgen
- Regulatory Milestone – FDA approval of the trial design marks a pivotal step toward bringing the therapy to U.S. patients and sets the stage for broader global development.
- Innovative Mechanism – No other approved drug combines PD‑1/TIGIT blockade with VEGF/TGF‑β inhibition, positioning Suzhou Zelgen at the forefront of next‑generation immuno‑angiogenic therapy.
- Commercial Potential – Successful outcomes could fast‑track the product to phase III, accelerating commercialization in the high‑growth oncology market.
Next Steps
Suzhou Zelgen plans to begin patient enrollment in late 2025, focusing on solid tumors with high PD‑L1 expression and angiogenic profiles. The company is also exploring partnership opportunities with U.S. oncology leaders to support trial execution and eventual market launch.-Fineline Info & Tech