On May 20, 2026, Beijing Sungen Biomedical Technology Co., Ltd., a strategic subsidiary of Hotgen Biotech, officially submitted an Investigational New Drug (IND) application to the National Medical Products Administration (NMPA). The application covers a potential new indication of SGC001 for severe acute pancreatitis, jointly developed with Beijing Institute of Heart, Lung and Blood Vessel Diseases of Anzhen Hospital. This milestone means the potential First-in-Class drug now embarks on multi-indication clinical development, following its ongoing Phase II trial for acute myocardial infarction.
Acute pancreatitis (AP) is a common acute digestive disorder requiring hospitalization. It occurs when abnormally activated pancreatic enzymes digest the pancreas and adjacent organs. Patients suffer sudden severe persistent upper abdominal pain accompanied by systemic inflammation. Severe cases may lead to organ failure and even death.
The global incidence ranges from 4.0 to 73.4 per 100,000 population. Around 20% of patients progress to moderately severe or severe acute pancreatitis. Such conditions bring prolonged hospital stay, elevated mortality rate, severe health threats and heavy financial burden on patients.
In accordance with the 2025 revised IAP Guidelines for the Management of Acute Pancreatitis, current treatments are mainly supportive care including fluid resuscitation, analgesia and nutritional support. No specific targeted therapeutic drugs are available yet, leaving huge unmet clinical needs. Safe and effective innovative medications are urgently required.
SGC001 is the world’s first-in-class antibody drug primarily indicated for acute myocardial infarction. Its target was discovered by Chinese scientists, and clinically developed by Sungen Biomedical, with its first clinical studies conducted in Chinese hospitals.
The drug inhibits inflammation and protects myocardium by targeting the S100A8/A9 pathway. Phase I clinical data confirmed satisfactory safety performance. The medium and high-dose groups showed myocardial infarct size reduced by 20.5% and 38.1% respectively versus the placebo group. It has secured clinical trial approvals in China and the United States, and obtained FDA Fast Track designation.
The first patient enrollment and dosing were completed on March 9, 2026. The Phase II investigator meeting was held in Beijing on April 25, attracting representatives from over 20 participating medical centers nationwide. The Phase II clinical trial is steadily advancing as scheduled.
Incubated by Hotgen Biotech, Sungen Biomedical is an innovation-driven biotech firm focusing on discovery, development and commercialization of First-in-Class antibody drugs. It has built world-class technical platforms and diversified pipelines covering cardiovascular, cerebrovascular and oncological therapies, striving to boost industrial innovation and safeguard human health worldwide.
Updated: May 23, 2026
