Milestone! Sungen Biomed's SGC001 Completes First Patient Enrollment and Dosing in Phase II Clinical Study for Expected Severe Acute Pancreatitis

SGC001, an innovative antibody drug jointly developed by Sungen Biomed (a controlled enterprise of Hotgen Biotech) and the Beijing Institute of Heart, Lung and Blood Vessel Diseases of Beijing Anzhen Hospital, affiliated with Capital Medical University, has completed the enrollment and dosing of the first patient in its Phase II clinical study for the "expected severe acute pancreatitis" indication. This is the second indication for SGC001 to enter clinical research, following acute myocardial infarction.

"The research team will always adhere to patient safety first, research quality first, and data authenticity first, strictly following GCP and the clinical trial protocol. Through high-quality randomized controlled studies, we will further answer the important scientific question of whether SGC001 can reduce the risk of organ function deterioration and disease progression to severe status through early intervention in the S100A8/A9-mediated inflammatory cascade, and explore new possibilities for the treatment of acute pancreatitis."

Acute pancreatitis, especially expected severe and severe acute pancreatitis, is a common acute and critical condition in clinical practice, characterized by rapid progression, multiple complications, and high mortality. According to the 2025 revised guidelines of the International Association of Pancreatology for the management of acute pancreatitis, current treatment is mainly based on fluid resuscitation, analgesia, nutritional support, and management of etiology and early complications; specific therapeutic drugs are still lacking, and clinical needs remain unmet.

SGC001 is an innovative monoclonal antibody targeting the S100A8/A9 pathway. Its first indication is acute myocardial infarction, making it the world's first First-in-Class antibody drug with a primary indication targeting acute myocardial infarction. It has obtained clinical trial approvals in both China and the United States, as well as FDA Fast Track designation; Phase I clinical studies have shown good safety and tolerability, laying the foundation for subsequent multi-indication clinical development. In the acute pancreatitis direction, preclinical cellular and animal studies have shown that SGC001, by modulating S100A8/A9-related inflammatory responses, can reduce inflammatory burden and alleviate acute pancreatitis-associated tissue and organ damage; in animal models, administration within a certain time window after disease onset still showed efficacy signals, with the potential to improve disease progression and survival outcomes. These results provide mechanistic and pharmacological rationale for expanding the acute pancreatitis indication.

The acute pancreatitis indication of SGC001 was approved by the National Medical Products Administration for clinical trial initiation on July 31, 2026. This Phase II study adopts a randomized, placebo-controlled design, with study centers initiating successively since August 2026, and completed enrollment and dosing of the first patient on September 30, marking that SGC001's clinical development in the field of acute inflammation-related diseases has entered a new stage.

Currently, the company is further expanding its clinical research network and plans to collaborate with approximately 15 high-level expert research centers in China that have experience in acute pancreatitis diagnosis and treatment and comply with GCP standards, to jointly advance patient identification, screening, enrollment, and standardized follow-up, so as to more systematically evaluate the safety, pharmacological characteristics, and potential clinical benefits of SGC001 in patients with expected severe and severe acute pancreatitis.