Sungen Biomedical's SGC001 Approved for Clinical Trial of New Indication: Predicted Severe Acute Pancreatitis

On July 31, 2026, Beijing Sungen Biomedical Technology Co., Ltd., a holding subsidiary of Beijing Hotgen Biotech Co., Ltd. (688068.SH), received the Drug Clinical Trial Approval Notice issued by China's National Medical Products Administration (NMPA). The notice approved SGC001 Injection to begin a clinical trial for the new indication of predicted severe acute pancreatitis.

This is another important development after SGC001 advanced clinical research in the field of acute myocardial infarction. It marks the further expansion of this innovative antibody drug into clinical development for multiple indications.

Focusing on Inflammation Regulation and Exploring Innovative Treatment Strategies

SGC001 Injection is an innovative monoclonal antibody drug targeting the S100A8/A9 pathway. It was jointly developed by the Sungen Biomedical research team and the Beijing Institute of Heart, Lung and Blood Vessel Diseases of Capital Medical University.

By targeting and regulating the S100A8/A9-related inflammatory pathway, the drug inhibits the release of inflammatory factors. It aims to reduce the risk of tissue damage caused by excessive inflammatory responses. Preclinical studies have shown that SGC001 has potential therapeutic effects in related animal models, providing support for future clinical research.

Clinical Development Has Already Advanced in Cardiovascular Emergencies

Previously, the clinical trial application for SGC001 in the indication of anterior ST-segment elevation myocardial infarction was approved by the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China's National Medical Products Administration. In March 2025, it also received FDA Fast Track designation.

At present, the Phase II clinical trial of SGC001 for this indication has been launched. The first subject has completed enrollment and dosing, and the study is progressing smoothly.

Expanding into Severe Acute Pancreatitis to Meet Clinical Treatment Needs

Acute pancreatitis is a common acute abdominal disease in clinical practice. Patients with severe acute pancreatitis often experience rapid disease progression and face great treatment difficulty. At present, treatment for this disease is still mainly supportive care. There remains a large clinical need for specific treatments targeting key parts of the inflammatory response.

The approval of the new predicted severe acute pancreatitis indication for SGC001 further expands the clinical development direction of this candidate drug. As an innovative antibody drug with First-in-Class potential, SGC001 is expected to explore new treatment strategies for acute and critical diseases through inflammation regulation.

Continuing Innovative Drug R&D and Supporting Breakthroughs in Life Science Innovation

The SGC001 project has received support from the Beijing Science and Technology Plan. It has been included by the Beijing Municipal Science and Technology Commission in a program for the cultivation of innovative pharmaceutical products and platforms. It has also received support from relevant national major science and technology projects.

In the future, Sungen Biomedical will continue to advance the clinical research of SGC001, accelerate the development of innovative drugs, and continue exploring new treatment solutions for major diseases with unmet clinical needs.

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