Zelgen gains NMPA approval for ZG006 clinical trial in neuroendocrine carcinoma

Suzhou Zelgen Biopharmaceuticals announced today it received approval from the National Medical Products Administration (NMPA) for the clinical trial of ZG006 for injection. This approval permits ZG006 to be used with etoposide and cisplatin for treating advanced neuroendocrine carcinoma. The company's clinical trial application was accepted on August 29, 2025.

ZG006 (alveltamig) is a first-in-class tri-specific antibody targeting two different DLL3 epitopes and CD3. It has received orphan-drug designation from the U.S. FDA and breakthrough therapy designation from both the U.S. FDA and China's NMPA. Preclinical studies demonstrated significant tumor inhibition, with a substantial proportion of mice achieving complete tumor regression.

The company cautioned that while this approval is a significant step, drug development is a lengthy and complex process with inherent uncertainties. There is no guarantee ZG006 will ultimately be approved for market launch. The company will continue to provide updates on the project's progress.