With a first-in-class approval in China, Eli Lilly’s GLP-1 development engine has delivered yet again on the obesity front—although local biopharma outfit Innovent Biologics will be the one to reap the rewards in the near term.
In a breakthrough for incretin medicines, China’s National Medical Products Administration (NMPA) has approved Innovent’s dual GLP-1/glucagon (GCP) receptor agonist mazdutide for chronic weight management in Chinese adults who are overweight or have obesity.
Crucially, patients must also have at least one weight-related comorbidity, such as high blood sugar or blood pressure, according to a statement (Chinese) from the country’s drug regulator.
The green light earns mazdutide the distinction of being the world’s first dual GCG/GLP-1 med, Innovent said in a June 27 press release. Innovent paid an undisclosed sum to secure the Chinese rights to mazdutide from Lilly in 2019, while Lilly continues to hold the rights to the metabolic drug outside of China, where it has yet to win approval.
Mazdutide, as a new entrant in the booming GLP-1 scene for obesity, recently ranked among Fierce Pharma’s top 10 most anticipated drug launches of 2025. That report leveraged data on prospective launches from intelligence and analytics firm Evaluate, which has estimated that the drug could reach $1.3 billion in 2030 sales.
The inaugural class of GLP-1 drugs began by targeting the eponymous glucagon-like peptide-1 receptor exclusively, though Lilly expanded the field in early 2022 with the FDA approval of its dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 drug tirzepatide. Tirzepatide was first cleared in type 2 diabetes as Mounjaro before scooping up an obesity nod under the name Zepbound in November 2023.
By targeting the GCG receptor, Lilly and Innovent figure mazdutide should help increase the body’s energy expenditure, spurring changes in the liver, brain and white and brown adipose tissue that complement the reduced energy intake triggered by GLP-1 activation.
China’s drug regulator based its approval on data from Innovent’s phase 3 GLORY-1 study in more than 600 adults in China who are overweight or obese. At the study’s 48-week mark, patients on mazdutide 4 mg, mazdutide 6 mg and placebo achieved an average weight loss relative to baseline of 12%, 14.8% and 0.5%, respectively.
Nearly 74% of patients on the 4 mg mazdutide dose and roughly 83% on the 6 mg formulation managed to shed at least 5% of their body weight from baseline, versus 11.5% of patients in the GLORY-1 study’s control arm, Innovent said. Meanwhile, 37% of patients on the 4 mg mazdutide dose and 50.6% of patients on the 6 mg dose lost at least 15% of their relative body weight, compared to just 2.1% of patients in the placebo group.
The drug was also shown to reduce liver fat content, with the 4 mg and 6 mg doses helping patients with a baseline liver fat content of 10% or more reduce those levels by 65.85% and 80.24% at 48 weeks, respectively. Patients in the dummy drug cohort only achieved an average liver fat reduction of 5.27%, Innovent pointed out.
In tandem with China’s goal to tackle the rise of obesity in the country, Innovent said it’s working on “accelerating the delivery” of mazdutide to Chinese patients. The chronic metabolic condition has been on the rise in China, with Innovent noting in its release that overweight and obesity accounted for 11.1% of deaths from chronic non-communicable diseases in the country in 2019. That figure was nearly double what it stood at in 1990, the company noted.
“We hope mazdutide will provide another therapeutic option for Chinese adults with overweight or obesity, improve their quality of life, and alleviate societal burdens,” Innovent’s senior vice president, Lei Qian, M.D., Ph.D., said in a statement. “Centered on patient needs and innovation, Innovent has established and will continue to expand its rich [cardiovascular and metabolic] pipeline with mazdutide as a cornerstone product.”
While boasting a novel mechanism of action, Innovent’s mazdutide will have to compete with Novo Nordisk’s obesity GLP-1 Wegovy and Lilly’s own Zepbound in China, where the companies’ blockbuster weight loss drugs were approved last June and July, respectively.
The competition could grow even fiercer next year when Wegovy is slated to lose patent protection, allowing domestic biosimilars to hit the scene in China, Bloomberg News noted. Meanwhile, multiple Chinese drugmakers—from Hengrui Pharmaceuticals to Sciwing Biosciences—are advancing through the clinic with promising data on their own GLP-1 assets for obesity.
Looking ahead, Innovent is already eyeing opportunities to grow mazdutide’s label and cement the drug’s status in the obesity market.
Last May, the company unveiled positive phase 3 data on mazdutide in 731 patients in China with type 2 diabetes, teeing up a regulatory filing in the country. Innovent is also trialing a higher dose, 9 mg formulation of mazdutide in obesity and pitting the asset against Novo’s entrenched semaglutide—the active ingredient in Wegovy and Ozempic—in both obesity and diabetes.
Elsewhere, the company is eyeing late-stage opportunities for its GLP-1/GCP receptor agonist in obesity with metabolic dysfunction-associated steatotic liver disease, adolescent obesity and obstructive sleep apnea. The company’s earlier-stage mazdutide pipeline includes studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction.
As for Lilly, the Indianapolis-based drugmaker is running a phase 2 trial of mazdutide in patients who are overweight or have obesity that is expected to wrap up imminently. The midstage trial has enrolled 179 participants and is mainly relying on U.S. sites.