Jiangsu Hengrui Pharmaceuticals (01276): The drug marketing authorization application for Reproglycosidase Injection has been accepted by the National Medical Products Administration.

Jiangsu Hengrui Pharmaceuticals (01276) announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., recently received an "Acceptance Notification" from the National Medical Products Administration (NMPA) indicating that the application for the marketing authorization of the companys Rybopag peptide injection has been accepted. This marketing application is based on two pivotal phase III clinical studies, PRIME-1 and PRIME-2, which evaluated Rybopag peptide injection in adult patients with type 2 diabetes mellitus (T2DM). The studies focused on T2DM patients who did not achieve adequate glycemic control after dietary and exercise interventions (placebo-controlled) and those with inadequate blood sugar control after treatment with metformin alone or in combination with sodium-glucose cotransporter-2 (SGLT2) inhibitors (semaglutide-controlled), assessing the efficacy and safety of Rybopag peptide injection. The PRIME-1 study was led by Professor Zhou Zhiguang from Xiangya Second Hospital of Central South University, involving 40 centers nationwide and enrolling 218 subjects. Results indicated that at week 36, the average reduction in HbA1c in the 4 mg group of Rybopag peptide injection was 2.67%. The PRIME-2 study, led by Professor Chen Limin from Tianjin Medical University Zhulian Memorial Hospital, opened 107 centers across the country and enrolled 884 subjects. At week 36, the average HbA1c reductions in the 4 mg and 2 mg groups were 2.78% and 2.34%, respectively, which were non-inferior compared to the 1 mg semaglutide group (average HbA1c reduction of 2.29%). For the key secondary endpoints, the glycemic efficacy of the 4 mg Rybopag peptide injection group was superior to that of the 1 mg semaglutide group (one-sided efficacy p < 0.0001). Regarding safety, Rybopag peptide injection showed good overall tolerability, with a safety profile consistent with previously reported clinical data and other GLP-1 class drugs. Diabetes is a metabolic syndrome characterized by hyperglycemia, resulting from defects in insulin secretion and/or insufficient insulin action. By 2024, the global number of diabetes patients is expected to reach 589 million, with approximately 148 million in China, ranking first in the world; it is anticipated that by 2050, the global diabetes patient count will increase to 853 million, with China's figures reaching 168 million. T2DM accounts for over 90% of all diabetes cases and is characterized by insulin resistance and progressive impairment of pancreatic -cell function. If hyperglycemia is not controlled promptly or is inadequately controlled, it can lead to irreversible vascular complications such as retinopathy, renal failure, myocardial infarction, stroke, and amputations. Currently, the treatment of T2DM employs a comprehensive management strategy, including lifestyle interventions, blood glucose monitoring, diabetes self-management education, and the use of antidiabetic medications. Lifestyle interventions are fundamental therapeutic measures for diabetes, and as the disease progresses, patients often need to gradually increase the combination of antidiabetic medications with different mechanisms of action. Among these, GLP-1 receptor agonists (GLP-1RA) have strong glycemic effects, effectively lowering blood sugar and weight while improving lipid profiles and lowering blood pressure. Rybopag is a dual agonist of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) independently developed by Jiangsu Hengrui Pharmaceuticals. It promotes insulin secretion, enhances insulin sensitivity, suppresses appetite, and regulates glucose and lipid metabolism, thereby improving blood sugar and reducing weight. Currently, globally, for the indication of T2DM, only Eli Lilly's drug tirzepatide injection (branded as Mounjaro) was approved in the United States in May 2022 and is expected to be approved in China in May 2024 (branded as Mufengda). According to the EvaluatePharma database, global sales of Mounjaro are expected to reach approximately $22.965 billion in 2025. To date, the cumulative R&D investment in the Rybopag project amounts to approximately 745.9 million yuan (unaudited).