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Mazdutide 9mg Supplementary Application Accepted for Review by China's NMPA, Potentially Offering a Novel Drug Option for Moderate-to-Severe Obese Population
Prnewswire· 2025-11-25 09:00
Core Viewpoint - Innovent Biologics has announced the acceptance of a supplementary application for the 9 mg dosage of mazdutide, a dual receptor agonist, aimed at long-term weight management in adults with moderate to severe obesity in China, addressing a significant unmet clinical need [1][2]. Group 1: Clinical Study Results - The Phase 3 clinical study GLORY-2 demonstrated that participants receiving mazdutide 9 mg achieved a mean weight reduction of 18.55%, compared to 3.02% in the placebo group, with 44.0% of participants in the mazdutide group losing 20% or more of their weight [4]. - The study also showed significant reductions in liver fat content (71.9% reduction) and improvements in key cardiometabolic parameters, including blood pressure and blood lipids, with no new safety signals identified [4][5]. Group 2: Treatment Context - In China, individuals with severe obesity face limited treatment options, with metabolic surgery being the current first-line recommendation, which is invasive and not widely applicable [2]. - Mazdutide 9 mg is positioned as a promising alternative to metabolic surgery, potentially filling a major clinical gap in obesity treatment [2][4]. Group 3: Product Development and Strategy - Innovent has conducted or completed seven Phase 3 clinical studies of mazdutide, with the first five meeting their primary endpoints, and ongoing studies in various obesity-related conditions [6]. - The company has entered into an exclusive license agreement with Eli Lilly for the development and commercialization of mazdutide in China, highlighting its strategic partnerships and market focus [5][13]. Group 4: Recognition and Future Prospects - Mazdutide has been recognized in top-tier journals and was selected as one of the "Top 10 Most Anticipated Drug Launches of 2025" by FIERCE Pharma, indicating strong market expectations [7][8]. - The drug is the first innovative treatment in China's endocrinology and metabolism field to have clinical results published in The New England Journal of Medicine, underscoring its clinical significance [8].