Suzhou Zelgen Biopharmaceuticals' ZGGS34 gets clinical trial nod for solid tumors

Suzhou Zelgen Biopharmaceuticals Co., Ltd. recently received approval from the National Medical Products Administration (NMPA) for the clinical trial of ZGGS34 for injection. This drug is intended for the treatment of MUC17-positive advanced solid tumors, marking a key step in its development. The approval notification was for a domestic drug registration clinical trial, with the application initially accepted on July 8, 2025.

ZGGS34 is a tri-specific antibody targeting CD3, CD28 on T-cells, and MUC17 on tumor cells. Preclinical studies have shown that ZGGS34 effectively inhibits tumor growth and demonstrates a strong anti-tumor effect across various cancer models, alongside a favorable safety profile in non-human primates. The drug will be administered as a lyophilized injection at 10mg per vial.

The company noted that while this approval is a positive development, it does not immediately impact its short-term financial performance. The pharmaceutical development process is inherently long, complex, and subject to numerous uncertainties, including regulatory approvals and substantial R&D investment, underscoring the inherent risks in drug commercialization.