Zelgen's ZG006 receives FDA orphan drug designation for neuroendocrine tumors

Suzhou Zelgen Biopharmaceuticals disclosed that its in-development product, ZG006, an injectable formulation, has received Orphan-drug Designation from the U.S. Food and Drug Administration (FDA) for treating neuroendocrine tumors. ZG006, also known as alveltamig, is a trispecific antibody drug developed through the company's bispecific/multispecific antibody research platform. It has already secured clinical trial approval from both the U.S. FDA and China's NMPA, and was previously designated as a breakthrough therapy by the NMPA's Center for Drug Evaluation.

ZG006 functions as a trispecific T-cell engager targeting two distinct DLL3 epitopes and CD3. Preclinical studies indicate that ZG006 demonstrates significant tumor inhibition in mouse models, leading to complete tumor regression in a substantial proportion of mice, suggesting potent anti-tumor activity. The company also presented clinical data for ZG006 and ZG005 at the 2025 European Society for Medical Oncology (ESMO) annual conference.

Receiving orphan drug designation provides policy support for ZG006's future development, registration, and commercialization in the U.S., including tax credits for clinical trial expenses, exemption from new drug application fees, and seven years of market exclusivity. However, the company cautions that the ultimate success of clinical trials, FDA marketing approval, and launch timelines remain uncertain, highlighting the inherent risks in pharmaceutical development.