Zelgen Biopharmaceuticals' ZG006 gets breakthrough therapy nod for cancer

Suzhou Zelgen Biopharmaceuticals announced its investigational product, ZG006 injection, has been included in the breakthrough therapy designation list by the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). The designated indication for ZG006 is as a monotherapy for patients with DLL3-positive advanced neuroendocrine tumors that have relapsed or progressed after at least platinum-based chemotherapy. The public comment period for this designation runs from November 24, 2025, to December 1, 2025.

ZG006, also known as alveltamig, is a tri-specific antibody developed on the company's bi- and multi-specific antibody research platform. It has also received Orphan-drug Designation from the U.S. FDA. The drug functions as a tri-specific T-cell engager targeting two distinct DLL3 epitopes and CD3, demonstrating significant tumor inhibitory effects in preclinical models.

The company notes that while this inclusion does not significantly impact short-term performance, drug development inherently involves lengthy cycles, extensive approvals, and substantial investment, with inherent uncertainties. Investors are advised to exercise caution.