Innovent Biologics, Inc. (HKG: 1801) announced that China’s National Medical Products Administration (NMPA) has accepted its supplementary application for mazdutide 9mg for long‑term weight management in adults with moderate to severe obesity, expanding the dual GCG/GLP‑1 agonist’s dosing options for severe disease.
Regulatory Milestone
Item
Detail
Product
mazdutide 9mg
Company
Innovent Biologics, Inc. (1801.HK)
Agency
NMPA (China)
Application Type
Supplementary application (new dosage)
Indication
Long‑term weight management in adults with moderate to severe obesity
Existing Approvals
Chronic weight management (adjunct to diet/exercise); glycemic control in T2D
Innovation:First domestic dual agonist with 9mg high‑dose option specifically targeting severe obesity
Dosage Strategy: 2‑4‑6mg for broad overweight/obese population; 3‑6‑9mg for severely obese
Clinical Value: Offers step‑up dosing to address varying disease severity
Clinical Evidence – GLORY-2 Study
Parameter
Result
Study
GLORY‑2 (NCT06164873), Phase 3 registration trial
Population
Chinese adults with moderate to severe obesity
Primary Endpoint
Met with significant weight reduction
Key Results (Week 60)
Mean weight reduction: 18.55%; 44.0% achieved ≥20% reduction
Liver Fat
Mean reduction: 71.9%
Cardiometabolic
Significant improvements in BP, lipids, uric acid, waist circumference
Safety
Favorable profile; no new safety signals
Market Context & Outlook
Metric
Value
China Severe Obesity Patients
>15 million adults
GLP‑1 Market Size
¥25 billion (US$3.4 billion) in 2024
Pricing (9mg)
Expected ¥800‑1,200/month (20% premium vs. 6mg)
Peak Sales Forecast
¥8‑12 billion (US$1.1‑1.6 billion) by 2030
Competitive Edge: High‑dose 9mg offers superior efficacy for severe obesity vs. competitor standard doses
Reimbursement Path: NRDL inclusion likely given disease burden and domestic innovation status
Forward‑Looking Statements This brief contains forward‑looking statements regarding mazdutide 9mg’s regulatory review, market potential, and commercial launch timeline. Actual results may differ materially due to risks including NMPA approval outcomes, competitive responses, and market adoption rates.-Fineline Info & Tech
By Fineline Cube 