Announcement on Voluntary Disclosure of Obtaining "Drug Clinical Trial Approval" for New Indication of Subsidiary's Innovative Drug SGC001 Injection
Securities code: 688068 Securities abbreviation: Rejing Biotechnology Announcement number: 2026-045
Beijing Rejing Biotechnology Co., Ltd.
Announcement on Voluntarily Disclosing the Subsidiary's Innovative Drug SGC001 Injection's Application for Clinical Trial for New Indications and Obtaining the "Drug Clinical Trial Approval Notice"
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents in accordance with the law.
Recently, Beijing Shunjing Biomedical Technology Co., Ltd. (hereinafter referred to as "Shunjing Pharmaceutical"), a subsidiary of Beijing Rejing Biotechnology Co., Ltd. (hereinafter referred to as the "Company" or "Rejing Bio"), received the "Drug Clinical Trial Approval Notice" approved and issued by the National Medical Products Administration (NMPA) , notification number 2026LP02325, the clinical trial application (IND) for the new indication of "anticipated severe acute pancreatitis" for the innovative drug SGC001 injection developed by Sunnyview Pharmaceuticals has been approved by the National Medical Products Administration (NMPA). The relevant information is now announced as follows:
1. SGC001 injection related information
SGC001 is an emergency monoclonal antibody drug jointly developed by the R&D team of Sunny Pharmaceuticals and the Beijing Institute of Cardiopulmonary and Vascular Diseases of Capital Medical University. It is suitable for the emergency treatment of patients with acute myocardial infarction (AMI) (the first indication is "anterior wall ST-segment elevation myocardial infarction"). Previously, for AMI disease, no relevant antibody drugs have entered the clinical research stage and have been approved for marketing. As of the date of this announcement, the clinical trial application (IND) of SGC001 has received clinical approval from the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of the State Drug Administration. In March 2025, it received Fast Track Designation from the U.S. Food and Drug Administration (FDA). The project has launched Phase II clinical trials, and completed the first subject's enrollment and administration on March 9, 2026. The SGC001 Phase II clinical investigators meeting was held in Beijing on April 25, 2026. More than 20 participating research centers across the country participated in the meeting. The current clinical progress is smooth. In addition, the SGC001 project of Shunjing Pharmaceutical has also been supported by the Beijing Municipal Science and Technology Plan Project, and has been listed as a pharmaceutical innovation variety and platform cultivation project by the Beijing Municipal Science and Technology Commission; and has received support from the 2026 "National Science and Technology Major Project for Innovative Drug Research and Development".
This time, SGC001, a targeted antibody candidate developed in collaboration with Anzhen Hospital’s Beijing Institute of Cardiopulmonary and Vascular Diseases, has applied for clinical trials (IND) for a new indication of “anticipated severe acute pancreatitis” and has been approved by the National Medical Products Administration (NMPA). This marks that this blockbuster drug candidate with potential First-in-Class (FIC) value has entered a new stage of clinical development for multiple indications after the launch of the first phase II clinical trial for acute myocardial infarction indications.
2. Disease characteristics and current status of diagnosis and treatment
According to the "International Society of Pancreatology Diagnosis and Treatment Guidelines for Acute Pancreatitis (2025 Revised Edition)", the treatment of acute pancreatitis mainly includes infusion therapy, analgesia and nutritional support, treatment of the cause and early complications, and mainly supportive therapy. There is no specific treatment drug for acute pancreatitis. There is a huge unmet clinical need, and the research of safe and effective innovative drugs is urgent. SGC001 targets the S100A8/A9 pathway, inhibits the release of inflammatory factors, and reduces local and systemic inflammatory responses. Preclinical animal model experiments indicate that the drug can exert its efficacy within 48 hours of onset and significantly reduce the mortality of model animals. Therefore, SGC001 is expected to bring an effective treatment option to patients with acute pancreatitis.
3. Risk warning
Innovative drugs are characterized by high technology, high risk, and high added value. The period from preclinical research to approval for marketing is long, and the process is easily affected by factors such as technology, approval, and policies. The company will continue to pay attention to the relevant research and development progress of the participating companies and fulfill its information disclosure obligations based on the research and development progress. Investors are kindly requested to pay attention to investment risks.
Announcement is hereby made.
Board of Directors of Beijing Rejing Biotechnology Co., Ltd.
August 1, 2026