San Francisco, China, September 12, 2024/PRNewswire/ -- Cinda Biopharmaceuticals Group (HKSE: 01801), a biopharmaceutical company dedicated to the development, production and sale of innovative drugs for major diseases such as tumors, autoimmunity, metabolism, cardiovascular, and ophthalmology, today announced the phase III clinical study (R&D code: IBI362) of the glucagon-like peptide-1 receptor (GLP-1R) /glucagon receptor (GCGR) dual agonist (R&D code:) in subjects with type 2 diabetes in China (DREAMS-2) The main findings of the study were revealed in the form of an oral report on major developments at the 60th European Association for the Study of Diabetes (EASD) annual meeting (abstract number: LBA 16). Research results proved that among Chinese type 2 diabetic subjects with poor blood sugar control after treatment with oral hypoglycemic agents, the curative effects of mast peptides in reducing sugar and weight loss were significantly superior to duracin peptides, while bringing comprehensive benefits to cardiovascular metabolism such as blood pressure, blood lipids, blood uric acid, and liver enzymes. Detailed research data will also be published in academic journals.

At the same time, the results of the first phase III clinical weight loss GLORY-1 study with Maxidu Peptide were also presented orally at this conference. As a breakthrough weight loss drug with “natural double targets, fat burning and liver protection, long-lasting weight loss, and comprehensive benefits”, Mast peptides also received widespread attention from participants.

731 Chinese type 2 diabetic subjects (mean age 51.8 years, mean baseline glycated hemoglobin [HbA1c] 8.22%, mean baseline body weight 76.95 kg) were enrolled in DREAMS-2 (NCT05606913) treated with metformin as a single agent or metformin in combination with other oral medications and were randomly treated for 28 weeks. The primary endpoint was a change in HbA1c from baseline.

The hypoglycemic efficacy of mast peptide* is superior to that of dura peptide*

Based on the efficacy estimation target, at week 28, HbA1c in the 4 mg and 6 mg groups decreased by an average of 1.69% and 1.73%, respectively, compared to the baseline, both significantly superior to the dura peptide group (1.36%); 71.2% and 74.2% of the subjects in the Mashidopeptide 4 mg and 6 mg groups, respectively, HbA1c < 7.0% (62.1% of the dura peptides group), with 54.8% and 63.1% of the subjects HbA1c ≤ 6.5% (42.1% of the dura peptides group), respectively The compliance rates were significantly higher than those of dulaccharide.

Key secondary endpoints showed that both maxidopeptide weight loss and HbA1c/body weight composite compliance rates were superior to duracin peptide*

At week 28, the body weight of the MSD 4 mg and 6 mg groups decreased by an average of 9.24% and 7.13% compared to the baseline, both significantly superior to the dura peptides group (2.86%); 62.4% and 78.2% of the subjects in the MSD 4 mg and 6 mg groups, respectively, had a weight drop of ≥ 5% from the baseline, and the compliance rate was significantly higher than that of the dura peptides group (26.9%). Furthermore, at week 28, 50.1% and 64.3% of the subjects in the Maxidopeptide 4 mg and 6mg group, respectively, had a body weight loss of at least 5% from the baseline and HbA1c < 7.0% (19.4% in the dura peptide group).

Maxidopeptide brings comprehensive benefits of multiple cardiovascular metabolic indicators

In addition to the above results, Maxidopeptide also showed significant and clinically significant improvements in indicators such as fasting blood sugar, postprandial blood sugar, waist circumference, blood pressure, blood lipids, blood uric acid, and aminotransferases. Most of the indicators improved more than duropeptides. Detailed results will be disclosed in academic journals.

Good safety and tolerability, no additional safety signals

• Maxidopeptide is well tolerated, leading to a low incidence of adverse events with early termination of treatment.
• The overall safety characteristics are consistent with previous clinical studies of Maxidu peptides, and no new safety signals were found. Gastrointestinal adverse reactions are the most common adverse events. Most of them are mild, moderate, or transient, and mainly occur during the titration period. There was no severe hypoglycemia in the mast peptide group, and the incidence of grade 1-2 hypoglycemia was comparable to that in the dura peptide group.

Maxidopeptide is the GLP-1R/GCGR dual agonist with the fastest clinical development process in the world. The marketing applications for the two indications have been reviewed by the National Drug Administration (NMPA) Drug Evaluation Center (CDE), respectively: 1) for long-term weight control in adult obese or overweight patients; 2) for blood sugar control in adult type 2 diabetics.

Professor Guo Lixin of the Department of Endocrinology at Beijing Hospital, said, “The incidence of type 2 diabetes in China is high, and a significant proportion of patients have overweight/obesity, cardiovascular and kidney disease. In recent years, GLP-1 receptor agonists have provided better treatment options for patients with type 2 diabetes due to their comprehensive benefits in blood sugar control, weight management, and cardiovascular kidney. Multiple agonists based on GLP-1 have become a hot topic and cutting edge in drug development for metabolic diseases. As the GLP-1R and GCGR dual-target agonist with the fastest clinical development in the world, Maxidopeptide proved the efficacy of glycemic peptides compared with the curative effects of sugar reduction and weight loss in type 2 diabetes subjects. At the same time, there are multiple metabolic benefits and good safety, which supports its use as a next-generation GLP-1 drug in the treatment of type 2 diabetes subjects in China. I look forward to the early entry of Mast peptides into clinical use, providing new treatment options for the vast majority of patients with type 2 diabetes suitable for the application of this type of drug, and helping improve the clinical outcomes of diabetics.”

Dr. Qian Lei, vice president of clinical development at Cinda Biopharmaceutical Group, said, “The number of diabetics in China is huge, and the prevention and treatment task is arduous. There is an urgent need for innovative drugs that are more effective, safer, and more convenient. Maxidopeptide is the fastest in clinical development in the world, and is the only GLP-1R/GCGR dual agonist that has completed registered clinical studies for type 2 diabetes so far. The results of the Phase 3 study of contrast glycemic peptides combined with oral hypoglycemic agents for treatment with type 2 diabetes in Chinese subjects were successful. The results were revealed in an oral report at this year's EASD conference, which proved the comprehensive benefits of mast peptides in blood sugar control, weight loss, and various metabolic indicators. “Combined with the results of DREAMS-1, a phase 3 study on the treatment of patients with type 2 diabetes, Cinda Biotech has submitted a marketing application for Maxidu peptide to the regulatory authorities and it has been accepted. We look forward to successful approval for the marketing of Maxidopeptide to benefit the majority of type 2 diabetics who need comprehensive improvements in blood sugar, body weight, and cardiovascular metabolism indicators.”

About diabetes

According to the Global Diabetes Survey released by the International Diabetes Federation in 2021, China has the highest number of diabetes subjects in the world. It is estimated that it will exceed 0.14 billion in 2021 and 0.174 billion in 2045 [1]. Poor blood sugar control can lead to irreversible microvascular and macrovascular complications such as vision loss, blindness, renal insufficiency, peripheral neuropathy, myocardial infarction, stroke, and amputation [2]. Diabetes has a high incidence rate, strong concealment, and serious complications. These three characteristics seriously threaten human health. Currently, there are many treatment options for diabetes. In addition to effectively controlling blood sugar, the development of novel hypoglycemic drugs is also exploring additional benefits for diabetics in terms of weight loss, cardiovascular risk reduction, and kidney protection [3].

About Maxidopeptide (IBI362)

Maxidopeptide (IBI362) is a glucagon-like peptide-1 receptor (GLP-1R) /glucagon receptor (GCGR) dual agonist jointly promoted by Cinda Biotech and Lilly Pharmaceuticals. As an analogue of mammalian gastric acid regulator (OXM), in addition to promoting insulin secretion, lowering blood sugar, and weight loss by stimulating GLP-1R, mast peptide can also increase energy consumption and enhance weight loss efficacy by stimulating GCGR, while improving liver fat metabolism. Maxidopeptide has shown excellent weight loss and hypoglycemic effects in several clinical studies, as well as reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes and liver fat content, and improving insulin sensitivity, bringing multiple metabolic benefits.

Currently, Maxidopeptide has two NDAs accepted for review by the NMPA, including:

• For long-term weight control in adults who are obese or overweight;
• Used for blood sugar control in adult type 2 diabetics.

Currently, a total of five phase III clinical studies have been carried out with Maxidopeptide, including:

• Phase III clinical study in overweight or obese subjects in China (GLORY-1);
• Phase III clinical study (GLORY-2) in subjects with moderate to severe obesity in China;
• Phase III clinical study (DREAMS-1) in newly treated Chinese patients with type 2 diabetes;
• A phase III clinical study (DREAMS-2) comparing maxidopeptide and duracopeptide in Chinese type 2 diabetic subjects with poor blood sugar control by oral medication;
• A phase III clinical study (DREAMS-3) of comparing mastradiol and simeglutide in subjects with type 2 diabetes and obesity in China.

Among them, GLORY-1, DREAMS-1, and DREAMS-2 studies have all reached an end.

About Cinda Biotech

“Beginning with faith, achieving action” is the mission and goal of Cinda Biotech to develop high-quality biopharmaceuticals that ordinary people can use. Established in 2011, Cinda Biotech is committed to developing, producing and selling innovative drugs for major diseases such as oncology, metabolism, cardiovascular, autoimmunity, and ophthalmology. The company has 11 products approved for marketing. At the same time, 3 varieties are in the NMPA review, 4 new drug molecules have entered phase III or key clinical research, and 18 new drug types have entered clinical research. The company cooperated deeply with domestic and foreign pharmaceutical companies to accelerate drug innovation, and reached more than 30 strategic partnerships with international partners such as Eli Lilly, Roche, Sanofi, Adimab, InCyte, and MD Anderson Cancer Center.

While continuously developing innovative drugs and seeking its own development, Cinda Biotech has always maintained scientific kindness, adheres to “patient-centered”, cares about patients and their families, and actively fulfills social responsibilities. Cinda Biotech hopes to work with everyone to raise the level of development of China's biopharmaceutical industry to meet people's accessibility to medicine and people's pursuit of a better life and health.

For more information, please visit our website: or Innovent Biologics on our LinkedIn account.

Disclaimer: Innovent does not recommend the use of unapproved drugs/indications.

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