Zelgen Bio gets NMPA nod for ZG006 combination trial in lung cancer

Suzhou Zelgen Biopharmaceuticals announced it has received approval from the National Medical Products Administration (NMPA) for a clinical trial of its ZG006 injection. The trial will investigate ZG006 in combination with PD-1/PD-L1 immune checkpoint inhibitors and chemotherapy (etoposide/carboplatin) for the treatment of small cell lung cancer. ZG006, an alveltamig injection, is a powder for injection developed by Suzhou Zelgen Biopharmaceuticals and Shanghai Zelgen Medical Technology Co., Ltd.

ZG006 is a first-in-class, three-specific antibody targeting two DLL3 epitopes and CD3, designed to connect tumor cells and T-cells to enhance tumor cell killing. The drug has previously received breakthrough therapy designation from both the U.S. FDA and China's NMPA, and orphan-drug designation from the FDA. Preclinical data showed significant tumor inhibition, including complete regression, in mouse models.

The company stated that this approval will not significantly impact its near-term financial performance. However, Zelgen Biopharmaceuticals cautioned investors about the inherent risks in drug development, including lengthy development cycles and regulatory uncertainties. The company will actively pursue the clinical trial and provide timely updates on its progress.