By Fineline Cube 
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received breakthrough therapy designation (BTD) from China’s Center for Drug Evaluation (CDE) for its investigational injectable ZG006. The designation applies to the monotherapy treatment of advanced small cell lung cancer (SCLC) in patients who have experienced relapse or progression after prior platinum-based chemotherapy and at least one other systemic therapy (third-line or later treatment).
Innovative Trispecific Antibody
ZG006 is a first-in-class trispecific antibody (TrAb) developed by Zelgen and its subsidiary Gensun Biopharma using their proprietary bispecific/multispecific antibody platform. This unique therapeutic agent targets two distinct DLL3 epitopes and CD3, making it the world’s first DLL3-targeting TrAb (DLL3×DLL3×CD3) with potential best-in-class efficacy. The drug has received clinical trial approvals in both China and the U.S., and was granted Orphan Drug Designation by the U.S. FDA.
Preclinical and Clinical Performance
Preclinical studies have demonstrated that ZG006 significantly inhibits tumor growth in mouse models, with complete tumor regression observed in some cases. Updated clinical data were presented at this year’s ASCO Annual Meeting, further highlighting the drug’s promising profile. Zelgen anticipates that ZG006 will receive priority review status during subsequent marketing filings.-Fineline Info & Tech