According to the Zhitong Finance APP, Zelgen Pharmaceuticals (688266.SH) announced that it recently received the "Notice of Approval for Clinical Trials of Drugs" issued by the National Medical Products Administration (referred to as "NMPA"). The clinical trial for the combination of injectable ZG005 and injectable ZG006 for advanced small cell lung cancer or neuroendocrine carcinoma has been approved.

Injectable ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody, an innovative tumor immunotherapy biological product, classified as Category 1, and is expected to be used for the treatment of various solid tumors. According to public inquiries, ZG005 is one of the first drugs in the world to enter clinical research targeting the same site, and currently, no similar mechanism drugs have been approved for marketing globally.

ZG005 has a dual-targeting effect that blocks PD-1 and TIGIT, effectively blocking the signaling pathway of PD-1 and its ligand PD-L1, thereby promoting T cell activation and proliferation; it also effectively blocks the signaling pathway of TIGIT and its ligand PVR, promoting the co-stimulatory activation signal generated by the binding of PVR and CD226, further promoting the activation and proliferation of T cells and NK cells, and enhancing the immune system's ability to kill tumor cells through the simultaneous blockade of both targets.

Injectable ZG006 is a trispecific antibody drug developed by the company and its subsidiary Gensun Biopharma Inc. through its bispecific/multispecific antibody research and development platform. It has obtained clinical trial approval from the U.S. FDA and China's NMPA, and has been granted orphan drug designation by the U.S. FDA. ZG006 is a trispecific T cell engager targeting two different DLL3 epitopes and CD3. According to inquiries, ZG006 is the world's first trispecific antibody targeting the DLL3 site (DLL3×DLL3×CD3) and is a first-in-class molecular form with the potential to become a best-in-class molecule.

The anti-DLL3 end of ZG006 binds to different DLL3 epitopes on the surface of tumor cells, while the anti-CD3 end binds to T cells. ZG006 connects tumor cells and T cells, bringing T cells closer to tumor cells, thereby utilizing T cells to specifically kill tumor cells. Preclinical research results show that ZG006 has significant tumor suppression effects in mouse tumor models, leading to a significant proportion of mouse tumors completely regressing, indicating that ZG006 has a strong tumor-killing effect