Suzhou Zelgen Biopharmaceuticals Co., Ltd. (688266.SH) announced that it has received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration (NMPA). The approval permits the clinical trial of ZG006 injection in combination with PD-1/PD-L1 immune checkpoint inhibitors and chemotherapy (etoposide/carboplatin) for the treatment of small cell lung cancer.

ZG006 (INN name: alveltamig) is a trispecific antibody drug developed through the company's bispecific/multispecific antibody platform. It has already obtained clinical trial approvals from both the U.S. FDA and China's NMPA. Additionally, it has been designated as a breakthrough therapy by the NMPA and granted Orphan Drug Designation by the U.S. FDA.

ZG006 is a trispecific T-cell engager targeting two distinct DLL3 epitopes and CD3. It is the world's first DLL3-targeting trispecific antibody (DLL3/DLL3/CD3) and represents a first-in-class molecular format with the potential to become a best-in-class therapy.

The anti-DLL3 component of ZG006 binds to different DLL3 epitopes on tumor cells, while the anti-CD3 component engages T cells. By bridging tumor cells and T cells, ZG006 brings T cells into proximity with tumor cells, enabling targeted tumor cell destruction.

Preclinical studies have demonstrated that ZG006 exhibits significant tumor suppression in mouse models, with a notable proportion of tumors showing complete regression, indicating its potent tumor-killing efficacy.