Zelgen begins pivotal trial for ZG006 in lung cancer

Suzhou Zelgen Biopharmaceuticals announced the initiation of a pivotal clinical trial for its investigational product, ZG006 injection, following conditional approval for market launch by China's NMPA Center for Drug Evaluation (CDE). The first patient has been enrolled in this crucial study, which targets advanced small cell lung cancer patients who have relapsed or progressed after at least two prior lines of therapy, including platinum-based chemotherapy.

ZG006 (alveltamig) is a first-in-class trimer-specific antibody developed using the company's bi-/multispecific antibody platform. It has received Breakthrough Therapy Designation in both China and the U.S., and Orphan Drug Designation from the U.S. FDA. The drug is designed to bridge DLL3-expressing tumor cells and CD3-positive T-cells to promote targeted killing.

The company plans to actively advance the clinical trial and, if results are favorable, will pursue conditional marketing approval. Zelgen cautions that the drug development process is lengthy and subject to uncertainties regarding trial outcomes, regulatory approvals, and eventual market launch.