By Fineline Cube 
Innovent Biologics Ltd. (HKG: 1801) announced that its mazdutide injection (IBI362) has received its second approval from China’s National Medical Products Administration (NMPA). The new indication authorizes use for glycemic control in adults with type 2 diabetes, making mazdutide the world’s first glucagon/GLP‑1 dual‑receptor agonist approved for this purpose.
What Mazdutide Brings to the Diabetes Landscape
- Dual‑Mechanism Action – As a mammalian oxyntomodulin (OXM) analog, mazdutide simultaneously activates the GLP‑1 receptor (promoting insulin secretion and lowering blood glucose) and the GCGR (boosting energy expenditure, weight loss, and liver fat metabolism).
- Complementary to Lifestyle – The drug is intended as an adjunct to a reduced‑calorie diet and increased physical activity, aligning with current diabetes management guidelines.
- First‑in‑Class – No other therapy combines these two pathways for diabetes treatment, offering a unique therapeutic option for patients who struggle to achieve glycemic targets with existing monotherapies.
Milestones in the Chinese Market
- June 2025 – First NMPA approval for long‑term weight management in adults.
- September 2025 – Second approval for type‑2 diabetes glycemic control.
- Strategic Implications – The dual indication expands Innovent’s revenue base and positions the company to capture a sizable share of the rapidly growing Chinese diabetes market, projected to exceed US$20 billion by 2030.
Co‑Development and Future Outlook
- Partnership – Mazdutide was co‑developed with Eli Lilly & Co., leveraging Lilly’s global development expertise.
- Pipeline Expansion – Innovent plans to pursue additional indications for mazdutide, including non‑alcoholic steatohepatitis (NASH) and obesity, in line with its broader OXM‑based platform.
- Regulatory Strategy – With two consecutive NMPA approvals, Innovent is well‑positioned to seek expedited FDA review, potentially accelerating global launch.-Fineline Info & Tech