INNOVENT BIO: Masitinib has been approved by the National Medical Products Administration of China for blood sugar control in adult patients with type 2 diabetes

According to the Zhitong Finance APP, INNOVENT BIO (01801) announced that the new drug application (NDA) for the second indication of Masitide Injection (glucagon (GCG)/glucagon-like peptide-1 (GLP-1) dual receptor agonist) has been approved for marketing by the National Medical Products Administration (NMPA) of China, for blood sugar control in adult patients with type 2 diabetes. Masitide is the world's first approved GCG/GLP-1 dual receptor agonist for type 2 diabetes, expected to assist the large population of type 2 diabetes patients in China in disease management, achieving blood sugar control, weight loss, and multiple benefits for heart, liver, and kidney indicators.

China has the highest number of type 2 diabetes patients in the world, with severe long-term blood sugar management and complication prevention needs

The number of adult diabetes patients in China has reached 140 million, ranking first in the world, accounting for about one-quarter of the global patient population. Diabetes has a long course, and prolonged high blood sugar can lead to serious complications such as cardiovascular diseases, kidney diseases, retinopathy, and neuropathy, which not only threaten the health and life of patients but also impose a significant economic burden on families and society.

In recent years, the treatment concept for diabetes has gradually shifted from blood sugar control to a "patient-centered" comprehensive management strategy for type 2 diabetes, which considers blood sugar management, weight management, cardiovascular risk factors, and the prevention of liver, heart, and kidney complications.

The consensus report on the management of hyperglycemia in type 2 diabetes jointly released by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) officially includes "weight loss" as one of the management goals for type 2 diabetes. Weight loss should be regarded as a treatment strategy to improve blood sugar control and reduce the risk of weight-related complications, with some type 2 diabetes patients aiming for a weight loss of 5%-15% as a primary treatment goal.

Masitide's superior efficacy in blood sugar control and weight loss, comprehensive benefits for metabolic, liver, heart, and kidney indicators, supporting Healthy China 2030

The GCG/GLP-1 dual receptor agonist stimulates the GCG receptor in addition to the GLP-1 receptor agonist, simultaneously improving the two core pathogenic mechanisms of diabetes: insufficient insulin secretion and insulin resistance, helping diabetes patients better control their blood sugar. Additionally, it can provide extra weight loss and comprehensive benefits for cardiovascular health, liver enzymes, and kidney metabolism for type 2 diabetes patients. Therefore, Masitide, as a safe, effective, and convenient new treatment option, can meet the long-term blood sugar management and complication prevention needs of type 2 diabetes patients, supporting the achievement of the "Healthy China 2030" goal.

This approval is primarily based on the results of two Phase III clinical studies, which validated the efficacy and safety of Masitide monotherapy (DREAMS-1, NCT05628311) and combination therapy with oral hypoglycemic agents (DREAMS-2, NCT05606913) in Chinese type 2 diabetes participants. Both studies demonstrated that Masitide was superior to placebo or dulaglutide 1.5mg in terms of blood sugar control and weight loss, and both showed improvements in multiple cardiovascular metabolic, liver, and kidney-related indicators.

In both studies, the safety of Masitide was similar to previous clinical studies and other GLP-1R agonists, with no new safety risks identified. The results of the DREAMS-1 study will be presented in a verbal report (306-OR) at the 2025 ADA Scientific Sessions, while the results of the DREAMS-2 study will be disclosed in a major progress verbal report (LBA 16) at the 2024 EASD Annual Meeting Based on its innovative mechanism and solid evidence from evidence-based medicine, Masitide has entered the consensus of clinical diabetes experts in China.

It is worth mentioning that the newly approved Masitide injection pen has significantly improved convenience and safety compared to existing similar injection devices. This injection pen features a hidden needle design, completely avoiding needle visibility throughout the process, effectively reducing patients' injection anxiety; at the same time, it is a disposable device, used and discarded immediately, significantly reducing the risk of drug contamination caused by reuse or replacement operations. In addition, this injection pen employs innovative X-section technology, achieving a smoother and painless injection experience, further enhancing patient comfort and compliance during treatment.

Masitide demonstrates excellent dual advantages in blood sugar reduction and weight loss, while also providing multiple potential metabolic benefits related to cardiovascular, liver, and kidney health, and showing good safety. The successful launch of Masitide reflects the high recognition of its clinical value and safety by the national drug regulatory authorities, and fully confirms the company's innovative research and development capabilities in the field of metabolic therapy. The company believes that Masitide will provide better treatment options for type 2 diabetes patients in China, contributing to the achievement of the Healthy China 2030 goals. Looking ahead, the company will continue to focus on four major therapeutic areas: oncology, autoimmune diseases, metabolism, and cardiovascular and ophthalmology, fulfilling its corporate mission of "developing high-quality biopharmaceuticals that are affordable for the public."

It is reported that Masitide (IBI362) is a GCG/GLP-1 dual receptor agonist jointly promoted by the company and Eli Lilly. As a mammalian gastric acid-regulating hormone (OXM) analog, Masitide not only promotes insulin secretion, lowers blood sugar, and aids in weight loss by activating GLP-1R, but also enhances weight loss efficacy by activating GCGR to increase energy expenditure, while improving liver fat metabolism. Masitide has demonstrated excellent weight loss and blood sugar reduction effects in multiple clinical studies, as well as reductions in waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, along with improvements in insulin sensitivity, bringing multiple metabolic benefits