---
title: "Mabwell Wins FDA Green Light for First-in-Human Trial of Novel Autoimmune Antibody 9MW5211"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/285754749.md"
description: "Mabwell (Shanghai) Bioscience Co., Ltd. has received FDA clearance for a first-in-human trial of its antibody candidate 9MW5211, aimed at treating inflammatory bowel disease. The trial will assess safety and tolerability in healthy subjects. The drug targets pathogenic immune cells and has shown promising preclinical results. Mabwell is expanding its global presence in autoimmune therapies, despite the uncertainties of drug development. The success of 9MW5211 could lead to significant market opportunities and improved patient outcomes, although future approvals depend on trial results and regulatory decisions."
datetime: "2026-05-08T15:07:52.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/285754749.md)
  - [en](https://longbridge.com/en/news/285754749.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/285754749.md)
---

# Mabwell Wins FDA Green Light for First-in-Human Trial of Novel Autoimmune Antibody 9MW5211

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Mabwell (Shanghai) Bioscience Co., Ltd. Class H ( (HK:2493) ) has issued an update.

Mabwell has received clearance from the U.S. Food and Drug Administration for a first-in-human clinical trial of its innovative antibody candidate 9MW5211 injection in inflammatory bowel disease, allowing a randomized, placebo-controlled single-ascending-dose study in healthy subjects to assess safety, tolerability and pharmacologic profiles. The drug, designed to selectively deplete pathogenic immune cells, has shown strong target selectivity, favorable preclinical safety and broad potential across autoimmune indications, while Chinese regulators have accepted clinical trial applications for multiple uses, underscoring Mabwell’s push into global precision therapies even as the company cautions investors about the inherent uncertainties of lengthy drug development cycles.

As the global burden of inflammatory bowel disease and multiple sclerosis continues to rise, 9MW5211’s novel mechanism and status as the first clinical-stage drug targeting its specific immune marker could enhance Mabwell’s competitive position in autoimmune therapeutics. Successful clinical progress could open a sizeable market opportunity and improve patient outcomes through deeper disease remission and potentially longer dosing intervals, though timelines and ultimate approvals remain contingent on future trial results and regulatory decisions.

**More about Mabwell (Shanghai) Bioscience Co., Ltd. Class H**

Mabwell (Shanghai) Bioscience Co., Ltd. is a China-based biopharmaceutical company focused on developing innovative antibody therapies for autoimmune and inflammatory diseases. The company targets conditions such as inflammatory bowel disease and multiple sclerosis, aiming to address growing global patient populations with precision immunology-based treatments.

**Average Trading Volume:** 4,456,755

**Current Market Cap:** HK$16.37B

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