---
title: "Zelgen: The clinical trial application for injectable ZGGS34 has been approved by the FDA"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/253592247.md"
description: "Zelgen announced that its clinical trial application for injectable ZGGS34 has been approved by the FDA, aimed at treating advanced solid tumors. ZGGS34 is a trispecific antibody drug targeting CD3 and CD28 on T cells and the tumor-associated antigen MUC17, demonstrating significant tumor suppression effects and good safety characteristics"
datetime: "2025-08-19T08:50:04.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/253592247.md)
  - [en](https://longbridge.com/en/news/253592247.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/253592247.md)
---

# Zelgen: The clinical trial application for injectable ZGGS34 has been approved by the FDA

According to the Zhitong Finance APP, Zelgen Pharmaceuticals (688266.SH) announced that its clinical trial application for the injectable ZGGS34 has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced solid tumors.

ZGGS34 is a trispecific antibody drug developed by the company and its subsidiary Gensun Biopharma Inc. through its bispecific/multispecific antibody research and development platform, 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.

Preclinical research results show that ZGGS34 has significant tumor suppression effects in various tumor models, leading to tumor regression, indicating that ZGGS34 has a strong tumor-killing effect. Completed toxicology studies of ZGGS34 in non-human primates demonstrate its controllable toxic side effects and good safety profile

### Related Stocks

- [688266.CN](https://longbridge.com/en/quote/688266.CN.md)

## Related News & Research

- [Trump’s name removed from Kennedy Center website branding](https://longbridge.com/en/news/289101851.md)
- [Ito En's (TSE:2593) Conservative Accounting Might Explain Soft Earnings](https://longbridge.com/en/news/289104874.md)
- [Innovation alone is no longer enough in biopharma](https://longbridge.com/en/news/289078638.md)
- [Commentary: Iran war has raised inflation risks. Why are Asian economies still growing?](https://longbridge.com/en/news/288972301.md)
- [Rubio says Netanyahu's Gaza plan clashes with Trump proposal](https://longbridge.com/en/news/289252288.md)