INNOVENT BIO (01801): Masidudipeptide has been approved by the China National Medical Products Administration for blood sugar control in adult type 2 diabetes patients.

INNOVENT BIO (01801) announced that the second indication for the new drug application (NDA) of Mashidu peptide injection (glucagon-like peptide-1 (GCG)/glucagon-like peptide-1 receptor agonist (GLP-1)) has been approved by the China National Medical Products Administration (NMPA) for adult type 2 diabetes patients for blood sugar control. Mashidu peptide is the world's first approved GCG/GLP-1 dual receptor agonist for type 2 diabetes, which is expected to help disease management in a large population of type 2 diabetes patients in China, achieving multiple benefits in blood sugar control, weight loss, and heart, liver, and kidney indicators. China ranks first in the number of type 2 diabetes patients globally, with a severe need for long-term blood sugar management and prevention of complications. There are 140 million adult diabetes patients in China, ranking first in the world, accounting for about one-fourth of the global number of patients. Diabetes is a chronic disease, and long-term high blood sugar can lead to serious complications such as cardiovascular disease, kidney disease, retinopathy, and neuropathy, posing a threat to the health and life of patients, as well as causing a significant economic burden on families and society. In recent years, the treatment concept of diabetes has gradually shifted from blood sugar control to a comprehensive management strategy for type 2 diabetes that focuses on the patient, with considerations for blood sugar management, weight management, cardiovascular risk factors, as well as liver, heart, kidney complications, and comorbidities. The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) jointly issued a consensus report on the management of hyperglycemia in type 2 diabetes, officially including "weight loss" as one of the treatment goals for type 2 diabetes management. Weight loss should be considered as a therapeutic strategy to improve blood sugar control and reduce the risk of weight-related complications. For some type 2 diabetes patients, weight loss of 5%-15% should be the primary treatment goal. Mashidu peptide controls blood sugar and reduces weight effectively, providing comprehensive benefits in the metabolism of the heart, liver, and kidneys, contributing to the achievement of the "Healthy China 2030" goal. The dual action of GCG/GLP-1 dual receptor agonist stimulates the GCG receptor on the basis of GLP-1 receptor stimulation, simultaneously improving the two major core pathogenic mechanisms of lacking insulin secretion and insulin resistance in diabetes, helping diabetes patients better control blood sugar. Additionally, it provides additional benefits in weight loss, cardiovascular, liver enzyme improvement, and comprehensive benefits in kidney metabolism for type 2 diabetes patients. Therefore, as a safe, effective, and convenient new treatment option, Mashidu peptide can meet the long-term blood sugar management and complication prevention needs of type 2 diabetes patients, contributing to the realization of the "Healthy China 2030" goal. The approval this time is mainly based on the results of two phase III clinical studies, verifying the efficacy and safety of Mashidu peptide monotherapy (DREAMS-1, NCT05628311) and combination therapy with oral antidiabetic drugs (DREAMS-2, NCT05606913) in Chinese type 2 diabetes participants. The two studies proved that Mashidu peptide is more effective in blood sugar control and weight loss than a placebo or dulaglutide 1.5mg. They also demonstrated improvements in various cardiovascular, liver, and kidney-related indicators. In both studies, the safety of Mashidu peptide was similar to previous clinical studies and other GLP-1R agonists, with no new safety risks identified. The results of the DREAMS-1 study were presented orally (306-OR) at the 2025 ADA scientific conference, while the results of the DREAMS-2 study were disclosed in the form of a major breakthrough oral presentation (LBA 16) at the 2024 EASD meeting. Based on its innovative mechanism and solid evidence-based medicine, Mashidu peptide has been included in the clinical consensus of experts in diabetes in China. It is worth noting that the approved Mashidu peptide injection pen has significantly improved convenience and safety compared to existing similar injection devices. The injection pen adopts a hidden needle design, avoiding the visibility of the needle throughout the process, effectively reducing patient injection anxiety. Furthermore, it is a disposable device, to be used and discarded immediately, significantly reducing the risk of drug contamination due to repeated use or replacement operations. In addition, the injection pen uses innovative X-cutting technology to achieve a smoother, painless injection experience, further enhancing patient comfort and compliance with treatment. Mashidu peptide demonstrates outstanding advantages in blood sugar reduction and weight loss, bringing potential multiple metabolic benefits related to the heart, liver, and kidneys, as well as showing good safety. The successful market launch of Mashidu peptide reflects the high recognition of its clinical value and safety by the national drug regulatory authority and fully confirms the company's innovative research and development capabilities in the field of metabolic treatment. The company believes that Mashidu peptide will bring better treatment options for type 2 diabetes patients in China, contributing to the achievement of the goals of "Healthy China 2030." Looking ahead, the company will continue to deepen its focus on the four major treatment areas of oncology, autoimmune diseases, metabolism, cardiovascular diseases, and ophthalmology, practicing the corporate mission of "Developing high-quality biopharmaceuticals that are affordable for LBX Pharmacy Chain Joint Stock." It is reported that Mashidu peptide (IBI362) is a GCG/GLP-1 dual receptor agonist co-promoted by the company and Lilly Pharmaceuticals. As a mammalian gastric acid regulator similar to oxyntomodulin (OXM), Mashidu peptide, in addition to promoting insulin secretion, lowering blood sugar, and reducing weight through GLP-1R stimulation, can also enhance weight loss efficacy by increasing energy expenditure through GCGR stimulation and improving liver fat metabolism. Mashidu peptide has shown excellent weight loss and blood sugar reduction efficacy in multiple clinical studies, as well as reducing waist circumference, blood lipids, blood pressure, uric acid, liver enzymes, liver fat content, and improving insulin sensitivity, bringing multiple metabolic benefits.