China’s regulatory agency accepts supplementary application of Innovent’s mazdutide 9 mg for moderate-to-severe obesity –
Follows positive topline results from the phase 3 GLORY-2 trial of mazdutide 9 mg announced last week
Innovent Biologics announced today that China’s National Medical Products Administration (NMPA) has accepted its supplementary application for the 9 mg dose of mazdutide, a dual GLP‑1/glucagon RA in people with obesity. Innovent licensed this candidate from Lilly in August 2019 for development and commercialization in China as a potential therapy for diabetes, obesity, and MASH.
Today’s news builds on last week’s announcement of positive topline results from the phase 3 GLORY-2 trial (n=462), which evaluated mazdutide 9 mg in Chinese adults with BMI ≥30 kg/m2. In the trial, mazdutide 9 mg conferred a mean weight loss of 19% at 60 weeks (vs. 3% with placebo) from a baseline of 94 kg (207 lbs). Nearly half of participants without diabetes achieved over 20% weight reduction, a strong result in line with other dual agonists on the market and in development.
Table of Contents []
China’s NMPA approved mazdutide for T2D and obesity earlier this year
As background, mazdutide received approval from China’s NMPA for glycemic management in adults with T2D in September 2025 and for weight management in adults with obesity or overweight in June 2025.
Innovent positions this as a potentially less invasive but highly effective alternative to metabolic surgery in a population with limited non-surgical options. We are excited to see how Innovent’s stratified dosing strategy and regulatory progress may expand therapeutic options for severe obesity in China and potentially beyond.
Today’s news another step in the regulatory process for promising candidate
This is an exciting development for mazdutide, which demonstrated a favorable safety profile with mostly mild-to-moderate transient GI events in the trial. Lilly retains the rights to develop mazdutide outside of China, and is studying the drug for the treatment of obesity (and alcohol use disorder, according to the company’s website).
Close Concerns’ Questions
- What is the expected timeline for NMPA’s review and potential approval of the 9 mg dose?
- Will Innovent pursue additional indications beyond glycemic and weight management, such as cardiorenal risk reduction?
- Given the strong GLORY-2 results and regulatory momentum in China, how is Lilly considering further global development of mazdutide outside of China?
--by Kayla Mathieu, Kat Moon, Monica Oxenreiter, and Kelly Close