Zhitong Finance App News, Hengrui Pharmaceutical (01276) issued an announcement. Recently, Fujian Shengdi Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”), received the “Notice of Acceptance” issued by the China Drug Administration (hereinafter referred to as the “State Drug Administration”), and the company's drug marketing license application for repropotide injections was accepted by the State Drug Administration.
This listing is based on two key multi-center, randomized, and controlled phase III clinical studies of repropotide injections in adult type 2 diabetes (T2DM) patients, namely the PRIME-1 study and the PRIME-2 study. The two studies evaluated the efficacy and safety of repropotide injections in T2DM patients with poor glycemic control after simple diet exercise intervention (placebo control) and poor glycemic control after treatment with metformin monotherapy or a sodium-glucose co-transporter 2 (SGLT2) inhibitor (simeglutide control).
Professor Zhou Zhiguang of the Second Xiangya Hospital of Central South University was the main researcher in the PRIME-1 study. A total of 40 centers were launched nationwide, and 218 subjects were randomly enrolled. The study results showed an average decrease of 2.67% in HbA1c in the 4 mg group of repropotide injection in week 36. Professor Chen Liming of Zhu Xianyi Memorial Hospital of Tianjin Medical University was the main researcher in the PRIME-2 study. A total of 107 centers were launched nationwide, and 884 subjects were randomly enrolled. Research results showed that in week 36, the average reduction in HbA1c in the 4 mg and 2 mg groups of repropotide injection reached 2.78% and 2.34%, respectively. Compared with the 1 mg group (HbA1c average decrease of 2.29%), the main endpoints all reached non-poor efficacy; in terms of key secondary endpoints, the 4 mg group of rippotide injection had excellent hypoglycemic effect compared to the 1 mg group (p<0.0001) with excellent efficacy on one side of simeglutide injection. In terms of safety, repropotide injections are generally well tolerated, and the safety characteristics are consistent with previously reported clinical data and other GLP-1 drugs.
Diabetes is a metabolic syndrome characterized by high blood sugar levels due to deficient insulin secretion and/or insufficient insulin action. In 2024, the number of diabetics in the world reached 589 million, and the number of diabetics in China is about 148 million, ranking first in the world; it is estimated that the number of diabetics worldwide will increase to 853 million in 2050, and the number of Chinese patients will reach 168 million. T2DM accounts for more than 90% of all diabetes cases and is characterized by insulin resistance and progressive loss of pancreatic beta cell function. If hyperglycemia is not controlled in a timely manner or is poorly controlled, it can cause irreversible vascular complications such as retinopathy, renal insufficiency, myocardial infarction, stroke, and amputation.
Currently, T2DM treatment uses comprehensive management strategies, including lifestyle interventions, blood sugar monitoring, diabetes self-management education, and application of hypoglycemic drugs. Lifestyle intervention is a basic treatment for diabetes. As the course of the disease progresses, patients often need a combination of hypoglycemic drugs with different mechanisms of action. Among them, the glucagon-like peptide-1 receptor agonist (GLP-1RA) has a strong hypoglycemic effect, can effectively reduce blood sugar and body weight, improve blood lipid profile, and lower blood pressure.
Rippotide is a glucagon-like peptide-1 (GLP-1) and glucose-dependent insulin-stimulating peptide (GIP) dual agonist independently developed by Hengrui Pharmaceutical. It can promote insulin secretion in the body, enhance insulin sensitivity, suppress appetite, and regulate carbohydrate metabolism, thereby improving blood sugar and weight loss. Currently, globally, for T2DM indications, only Eli Lilly's terpotide injection (trade name: Mounjaro) was approved for marketing in the US in May 2022, and in China (trade name: Mu Fengda) in May 2024. According to the EvaluatePharma database, Mounjaro's total global sales in 2025 were approximately US$22.965 billion. Up to now, the total R&D investment in repropeptide-related projects is about 74.5.9 million yuan (unaudited).