---
title: "Zelgen: Injectable ZGGS34 has received approval for clinical trials"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/257677420.md"
description: "Zelgen recently received approval from the National Medical Products Administration for the clinical trial of injectable ZGGS34 for MUC17 positive advanced solid tumors. ZGGS34 is a trispecific antibody drug that can connect tumor cells with T cells, activating T cells to kill tumor cells. Compared to traditional T cell engagers, ZGGS34 introduces a CD28 agonistic antibody, enhancing T cell activation and anti-tumor effects. Preclinical studies have shown that ZGGS34 has significant inhibitory effects in various tumor models and demonstrates good safety characteristics in non-human primates"
datetime: "2025-09-17T08:14:05.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/257677420.md)
  - [en](https://longbridge.com/en/news/257677420.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/257677420.md)
---

# Zelgen: Injectable ZGGS34 has received approval for clinical trials

According to the Zhitong Finance APP, Zelgen Pharmaceuticals (688266.SH) announced that it has recently received the "Notice of Approval for Clinical Trials of Drugs" issued by the National Medical Products Administration (hereinafter referred to as "NMPA"), approving the clinical trial of injectable ZGGS34 for MUC17 positive advanced solid tumors.

ZGGS34 is a trispecific antibody drug developed by the company, belonging to the class of trispecific T cell engagers (TriTE). ZGGS34 (MUC17/CD3/CD28) is a trispecific antibody targeting CD3 and CD28 on T cells as well as the tumor-associated antigen (TAA) MUC17. MUC17 (Mucin-17) is a transmembrane mucin that is abnormally highly expressed in gastric cancer, gastroesophageal junction cancer, pancreatic cancer, and colorectal cancer, and has become a popular target for the diagnosis and treatment of gastrointestinal tumors in recent years. One end of the ZGGS34 molecule binds to MUC17 on the surface of tumor cells, while the anti-CD3 and anti-CD28 ends bind to T cells. ZGGS34 connects tumor cells and T cells, bringing T cells closer to tumor cells, leading to the formation of an immune synapse, activating T cells, and producing perforin, granzyme, and cytokines to kill tumor cells. Compared to typical T cell engagers (BiTE), ZGGS34 introduces a CD28 agonistic antibody, where CD28 is a key second signal for T cell activation, primarily expressed on the surface of T cells, and is crucial for T cell activation, proliferation, and survival. After CD28 binds to CD80/CD86 on antigen-presenting cells (APC), it lowers the TCR activation threshold, enhancing T cell proliferation, metabolism, and anti-apoptotic capabilities, thereby giving ZGGS34 a stronger ability to activate T cells and sustained T cell tumor-killing capability compared to typical BiTE molecules, enhancing anti-tumor immune effects.

Preclinical research results show that ZGGS34 has significant tumor-suppressive effects in various tumor models, leading to tumor regression, indicating that ZGGS34 has a potent tumor-killing effect. Completed toxicology studies of ZGGS34 in non-human primates have shown good safety characteristics

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