NMPA IND Submission! Sungen Biomedical's New SGC001 Indication, Predicted Severe Acute Pancreatitis, Officially Enters a New Stage of Clinical Development

On May 20, 2026, the Investigational New Drug (IND) application for a new indication of SGC001, an investigational targeted antibody drug, was officially submitted to China's National Medical Products Administration (NMPA).

SGC001 is being jointly developed by Beijing Sungen Biomedical Technology Co., Ltd., a strategically controlled company of Beijing Hotgen Biotech Co., Ltd., and the Beijing Institute of Heart, Lung and Blood Vessel Diseases of Anzhen Hospital.

This marks a new stage of multi-indication clinical development for this major candidate drug with potential First-in-Class (FIC) value, following the launch of its Phase II clinical trial for the first indication of acute myocardial infarction.

Acute pancreatitis (AP) is a common digestive system emergency that often requires hospitalization. It is caused by abnormal activation of pancreatic enzymes, which digest the pancreas itself and surrounding organs. The disease usually begins with sudden and persistent severe upper abdominal pain and is often accompanied by systemic inflammatory response. Severe cases may lead to organ dysfunction or death.

Acute pancreatitis has a high incidence rate, with a global incidence of 4.0 to 73.4 cases per 100,000 people. About 20% of patients may progress to moderately severe acute pancreatitis (MSAP) or severe acute pancreatitis (SAP). Patients with severe acute pancreatitis usually have much longer hospital stays and a significantly higher mortality rate. This seriously harms patient health, while high treatment costs also create a heavy financial burden.

According to the International Association of Pancreatology Guidelines for the Diagnosis and Treatment of Acute Pancreatitis (2025 Revision), current treatment for acute pancreatitis mainly includes fluid therapy, pain relief, nutritional support, and treatment of causes and early complications. These are mainly supportive treatments. At present, there is still no specific drug for acute pancreatitis, so there is a major unmet clinical need. The development of safe and effective innovative drugs is urgently needed.

SGC001 targets and blocks the S100A8/A9 pathway, inhibits the release of inflammatory factors, and reduces local and systemic inflammatory responses. Preclinical animal studies suggest that SGC001 may still be effective when used within 48 hours after disease onset and may significantly reduce mortality in animal models. Therefore, SGC001 is expected to provide an effective treatment option for patients with acute pancreatitis.

SGC001 is the world's first First-in-Class antibody drug whose main indication is acute myocardial infarction. Its target was discovered by Chinese scientists, successfully translated by Sungen Biomedical, and first studied clinically by Chinese hospitals. The drug protects the myocardium by targeting the S100A8/A9 pathway and inhibiting inflammation.

Phase I clinical data showed good safety. Compared with the placebo group, the myocardial infarction area in the medium-dose and high-dose groups was reduced by 20.5% and 38.1%, respectively. The drug has received clinical trial approvals in both China and the United States, as well as FDA Fast Track designation.

On March 9, 2026, the first subject was enrolled and dosed. On April 25, 2026, the SGC001 Phase II clinical investigator meeting was held in Beijing, with more than 20 participating research centers across China attending. At present, the Phase II clinical study is progressing as planned.

About Sungen Biomedical

Sungen Biomedical, incubated by Hotgen Biotech, is an innovation-driven biomedical technology company. It is committed to the discovery, development, and commercialization of original First-in-Class antibody drugs.

With strong scientific research and innovative drug development capabilities, the company has built a series of internationally advanced technology platforms. Guided by unmet clinical needs, it has established multiple original biologic macromolecule drug pipelines with strong market potential, covering cardiovascular and cerebrovascular diseases, tumors, and other disease areas. The company aims to improve China's new quality productive forces and benefit human health.

Non-Inducement Statement

This press release contains forward-looking statements, which are mainly based on the current views, expectations, estimates, and predictions of the company's management. Words such as "hope," "expect," "believe," "may," "design," "effect," "evaluate," "forecast," "goal," "plan," "purpose," "will," "intend," and similar expressions related to the company are intended to indicate forward-looking statements.

Forward-looking statements are affected by risks and uncertainties. Many of these risks are difficult to predict and are usually beyond the company's control. As a result, actual results may differ from those described in the forward-looking statements. The company has no obligation to publicly update or revise any forward-looking statements.