Innovent Biologics, Inc. (1801) reported that the supplementary application for Mazdutide 9mg, a glucagon/glucagon-like peptide-1 dual receptor agonist, was accepted for review by China’s National Medical Products Administration (NMPA). The proposed dosage is aimed at long-term weight management for adults with moderate to severe obesity, extending current treatment options beyond standard metabolic therapies and bariatric surgery.
According to the announcement, the acceptance is based on Phase 3 data from the GLORY-2 trial (NCT06164873). At week 60, the Mazdutide 9mg group achieved a mean weight reduction of 18.55% compared with 3.02% in the placebo group. Moreover, 44.0% of participants in the 9mg group experienced at least a 20% body weight reduction. Among participants without type 2 diabetes, a 20.08% mean reduction was documented by week 60, and 48.7% of those without diabetes achieved at least a 20% reduction. The study also observed significant improvement in liver fat content, blood pressure, blood lipids, and serum uric acid, with no new safety signals reported.
The announcement highlights that Mazdutide 9mg is currently identified as the only GLP-1 receptor agonist achieving over 20% weight loss after one year of treatment in obese adults without type 2 diabetes using a 2-step dose titration. In addition, the broader Mazdutide portfolio—covering dosages from 2mg through 9mg—targets various levels of obesity and associated clinical needs. The group also reaffirmed progress in multiple Phase 3 clinical studies evaluating Mazdutide in overweight or obese adults with or without type 2 diabetes, several of which have already met primary endpoints.
The drug has two approved indications in China: chronic weight management under specific body mass index thresholds in adult patients, and glycemic control for adults with type 2 diabetes when used alone or in combination with other antidiabetic therapies. The announcement referenced recognition of Mazdutide’s clinical value in scientific publications and at key conferences. The company stated that it will continue working with the regulatory authority to advance the approval process for this new dosage option.
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