Category: Clinical Trial Update Region: North America

Innovent’s Mazdutide 9 mg Moves One Step Closer to Approval in China

Innovent’s Mazdutide 9 mg Moves One Step Closer to Approval in China

China may soon have a powerful new option for treating moderate to severe obesity.
Innovent Biologics announced that the National Medical Products Administration (NMPA) has accepted the supplementary application for mazdutide 9 mg, a next-generation dual GCG/GLP-1 receptor agonist designed for long-term weight management.

The drug targets a major unmet need in China, where treatment options for severe obesity remain limited and often invasive.

Backed by Strong Phase 3 Results

The application is based on data from GLORY-2, a phase 3 trial in Chinese adults with moderate to severe obesity.
The trial hit all primary and key secondary endpoints.

Headline Results from Week 60

  • 18.55% mean weight loss with mazdutide 9 mg vs 3.02% with placebo.
  • 44% of patients achieved ≥20% weight reduction, compared to 2.6% on placebo.
  • In participants without type 2 diabetes, weight loss reached 20.08%, with 48.7% achieving ≥20% reduction.

Notably, weight loss continued without plateau, a rare outcome for obesity drugs after one year.

Impact Beyond the Scale

Mazdutide delivered meaningful metabolic improvements:

  • 71.9% reduction in liver fat content
  • Significant reductions in blood pressure, lipids, uric acid
  • Notable decreases in waist circumference

Safety remained favorable, with no new signals reported.

Detailed data will be shared at upcoming global conferences.

Why This Matters for China?

Professor Linong Ji, a leading endocrinologist and principal investigator, highlighted a key challenge:

Patients with severe obesity (BMI > 32.5 kg/m²) often have only one option—metabolic surgery.

But surgery is invasive, costly, and often underused due to patient hesitation.

Mazdutide 9 mg could become a high-precision oral alternative with weight-loss efficacy approaching surgical levels. This makes the drug a potential breakthrough for millions of patients who lack practical long-term solutions.

Innovent’s Growing Obesity Portfolio

Dr. Lei Qian, Chief R&D Officer, emphasized Innovent’s strategy: a stratified, personalized dosing system.

  • 2 mg–4 mg–6 mg for broad overweight and obese populations
  • 3 mg–6 mg–9 mg specifically for severe obesity

Mazdutide 9 mg is currently the only GLP-1-based therapy in China to show over 20% weight loss in non-diabetic adults after one year with a simple, two-step titration.

Powered by Dual-Pathway Science

Mazdutide is a mammalian oxyntomodulin analogue licensed exclusively from Eli Lilly for China.
It activates both:

  • GLP-1 receptors — supporting glucose control and appetite reduction
  • Glucagon receptors — increasing energy expenditure and improving liver fat metabolism

This dual action drives broad metabolic benefits beyond weight loss.

Innovent’s progress signals a major shift in China’s obesity treatment landscape. If approved, mazdutide 9 mg could redefine long-term weight management for patients who have had limited, often invasive choices.

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