Innovent reports NMPA approval of a prefilled multi-dose pen for mazdutide, its dual GCG/GLP-1 receptor agonist for type 2 diabetes in China. The device supports flexible dose titration and long-term diabetes management.
Written By: Farha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
Innovent Biologics announced that China’s National Medical Products Administration (NMPA) has approved a prefilled multi-dose pen formulation of mazdutide, the company’s dual glucagon (GCG) and GLP-1 receptor agonist for adults with type 2 diabetes (T2D). The device is intended to support flexible long-term dosing and individualized diabetes management.
According to Innovent, the approved pen contains 24 mg of mazdutide in a 2 mL formulation and allows dose titration at 2 mg, 4 mg, and 6 mg using a single device. The company said the format may help clinicians adjust treatment based on glycemic control and concomitant therapies during treatment initiation, escalation, and maintenance. Innovent also stated that the pen can be stored at 2–8°C for up to 12 weeks after first use.
Dual-Target Therapy for Glucose and Metabolic Control
Mazdutide is described by Innovent as the first approved dual GCG/GLP-1 receptor agonist globally. Beyond GLP-1 receptor activation, the therapy also targets the glucagon receptor, aiming to address both impaired insulin secretion and insulin resistance associated with T2D.
The company said mazdutide has demonstrated benefits beyond glycemic control, including reductions in body weight and improvements in blood pressure, lipid levels, uric acid, and liver enzyme markers.
Innovent cited data from the International Diabetes Federation’s 2025 report showing that China had an estimated 148 million people living with diabetes in 2024, with projections reaching 168 million by 2050. The company also noted that more than 60% of Chinese patients with T2D may have fatty liver disease, reflecting the growing overlap between diabetes and metabolic liver disorders in the country.
Phase 3 Studies Published in Nature
The approval announcement follows publication of the Phase 3 DREAMS-1 and DREAMS-2 studies in Nature in December 2025. According to Innovent, treatment with mazdutide 6 mg for 24 weeks reduced HbA1c by up to 2.15%, outperforming placebo and Dulaglutide in the respective studies.
The studies also reported improvements in fasting glucose, seven-point self-monitored glucose profiles, waist circumference, blood pressure, blood lipid parameters, and liver enzyme levels, supporting the potential metabolic effects of dual GCG/GLP-1 receptor activation.
Broad Clinical Development Program Ongoing
Innovent licensed mazdutide from Eli Lilly and Company for development and commercialization in China. The therapy is being evaluated across multiple metabolic disease indications, including obesity, metabolic dysfunction-associated steatohepatitis (MASH), obstructive sleep apnea, hypertension, and heart failure with preserved ejection fraction (HFpEF).
According to the company, mazdutide has been studied in nine Phase 3 clinical trials. Five studies, including DREAMS-1 (NCT05628311), DREAMS-2 (NCT05606913),and GLORY-1, have met their primary endpoints, while four additional Phase 3 trials remain ongoing.
Mazdutide has already received NMPA approvals in China for chronic weight management and glycemic control in adults with T2D, including use as monotherapy and in combination treatment settings.
Reference
Zhu, D., Zhao, J., Cai, H. et al. Mazdutide versus placebo in Chinese adults with type 2 diabetes. Nature 652, 174–180 (2026). https://doi.org/10.1038/s41586-025-10026-w
Guo, L., Zhang, B., Xue, X. et al. Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes. Nature 652, 181–188 (2026). https://doi.org/10.1038/s41586-025-10031-z
About the Writer
Farha Farheen, PharmD (LinkedIn), is a pharmacy professional with a strong interest in pharmacovigilance and clinical research. She has completed her Doctor of Pharmacy (Pharm.D) along with her internship as a Clinical Pharmacist. She has hands-on experience in adverse drug reaction (ADR) reporting, safety data documentation, and pharmacovigilance workflows, and is proficient in using VigiFlow. She is also a patent holder for an antibacterial formulation enriched with bioactive substances, granted by the German Patent and Trademark Office.