Suzhou Zelgen Gains NMPA Approval for ZG005 and ZG006 Combination Trial in Advanced Cancers

Suzhou Zelgen Gains NMPA Approval for ZG005 and ZG006 Combination Trial in Advanced Cancers

China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its ZG005 combined with ZG006. The combination will enter trials targeting advanced small cell lung cancer (SCLC) or neuroendocrine carcinoma.

ZG005: First-of-its-Kind Bispecific Antibody
ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody (BsAb) with potential applications in treating various solid tumors. It is one of the first of its kind to enter clinical studies globally, with no similar drugs currently approved worldwide. The drug dually blocks both PD-1/PD-L1 and TIGIT/PVR signaling pathways, activating T cells and NK cells to enhance the immune system’s antitumor activity.

ZG006: First-in-Class Trispecific Antibody
ZG006, developed by Suzhou Zelgen and its subsidiary Gensun Biopharma Inc. using their bispecific/multispecific antibody platform, represents the world’s first DLL3×DLL3×CD3 trispecific antibody with first-in-class potential. It has already received orphan drug designation from the U.S. FDA. By simultaneously binding to DLL3 epitopes on tumor cell surfaces and CD3 molecules on T cells, ZG006 precisely directs T cells to recognize and eliminate tumor cells. Preclinical data demonstrated significant tumor suppression effects in mouse models.-Fineline Info & Tech