Innovent announces the completion of the first dose of mazdutide (IBI362) in a Phase III clinical study (DREAMS-2) in subjects with type 2 diabetes in China

Innovent Biopharmaceutical Group (HKEx stock code: 01801), a biopharmaceutical company dedicated to the development, production and marketing of innovative drugs for the treatment of major diseases such as oncology, autoimmunity, metabolism, ophthalmology, etc.
, announced: glucagon-like peptide-1 receptor (GLP-1R) / glucagon receptor, GCGR) dual agonist mazdutide (R&D code: IBI362) was administered
in a multicenter, randomized, dulaglutide-controlled phase III clinical study (DREAMS-2) in subjects with type 2 diabetes in China.

This study is a Phase III clinical study comparing the efficacy and safety of mazdutide and dulaglutide in Chinese subjects with type 2 diabetes mellitus treated with metformin monotherapy or metformin combined with sodium-glucose co-transporter 2 (SGLT2) inhibitors/sulfonylureas in Chinese subjects with type 2 diabetes mellitus who have poor glycemic control (ClinicalTrials.
gov, NCT05606913).

。 The study planned to include approximately 720 subjects randomized to mazdutide 4.
0 mg, mazdutide 6.
0 mg, or dulaglutide 1.
5 mg in a 1:1:1 ratio for a total of 28 weeks
.
The primary endpoint of the study was change
in participants' glycated haemoglobin (HbA1c) levels from baseline at week 28.

Previously, the results of a phase II clinical study (ClinicalTrials.
gov, NCT04965506) in subjects with type 2 diabetes in China showed that mazdutide was well tolerated and the overall safety profile was similar to that of similar
drugs.
20 weeks after administration,

● The change in HbA1c from baseline was as high as -1.
67% in the mazdutide group (0.
03% in the placebo group and -1.
35% in the dulaglutide group)

● The percentage change in weight from baseline was as high as -7.
11% in the mazdutide group (-1.
38% in the placebo group and -2.
69% in the dulaglutide group).

● In addition, mazdutide can also reduce blood pressure, blood lipids and liver enzyme levels, bringing comprehensive benefits
to subjects.

This phase III clinical study, DREAMS-2, will further validate the efficacy and safety of mazdutide and compare the efficacy and safety
of mazdutide with dulaglutide.

Professor Yang Wenying, the principal investigator of this study and China-Japan Friendship Hospital, said: "At present, patients with type 2 diabetes in China still have a low overall blood glucose compliance rate, and patients often combine a variety of cardiovascular risk factors, such as obesity, hyperlipidemia, coronary heart disease, fatty liver, gout, etc.
, which not only increases the burden of disease of patients, but also increases the difficulty
of treatment.
Clinically, there is an urgent need for innovative drugs
with definite efficacy, good safety, convenient administration, low risk of hypoglycemia, and a variety of cardiovascular benefits.
The results of the phase II clinical study of Mazdutide in Chinese patients with type 2 diabetes not only showed significant hypoglycemic efficacy, but also showed the potential of effective international mainstream drug dulaglutide in weight loss indicators
.
I believe that mazdutide will achieve better results in the phase III study and look forward to its early filing for the benefit of patients
.
" "

Professor Guo Lixin, the principal investigator of this study, said: "GLP-1 drugs have received more and more attention because of their significant hypoglycemic effect, lower hypoglycemic risk, obvious weight benefit and protective effect on cardiovascular and other target organs in the treatment of diabetic patients, and are gradually used
by more and more front-line clinicians.
At present, GLP-1 dual-target drugs are becoming a hot spot in the development of the next generation of GLP-1 products, and based on the benefits brought by multiple targets, its more obvious hypoglycemic and weight-reducing effects have also attracted more attention
from academia and clinical fields.
As the best representative of GLP-1 dual-target drugs, Mazudutide's clinical development is deeply rooted in China, the entire development project is based on Chinese, and its phase II clinical results have shown good hypoglycemic and weight reduction effects, blood lipids, blood blood pressure, blood uric acid improvement and liver protection and other multiple benefits
.
Mazudutide, as an innovative molecule in the field of GLP-1 dual targets and the drug that provides the most Chinese clinical evidence, will surely bring better, newer and closer to Chinese clinical practice options
for Chinese doctors and patients.
"

Dr.
Qian Lei, Vice President of Clinical Development, Innovent Biopharmaceutical Group, said, "The phase II results of Mazdutide in Chinese subjects with type 2 diabetes fully demonstrate the significant efficacy and good safety of GLP-1R/GCGR dual agonists, showing their great application value
.
These results provide a solid foundation for conducting Phase III clinical studies, and we are confident that we will see further manifestations of mazdutide's excellent efficacy in Phase III clinical trials
.
" Mazutide's overall development plan and key registry study design in China have been communicated with regulators and received positive feedback, and we will continue to bring mazdutide to doctors and patients as quickly as possible through efficient and solid clinical research and scientific development
.
I look forward to the success of mazdutide in the Phase III clinical study and strive to provide more friendly, effective and safer clinical drug options
for patients with type 2 diabetes at an early date.
" "