China approves mazdutide for type 2 diabetes, a first for dual GCG/GLP-1 drugs

China's National Medical Products Administration approved mazdutide for glycemic control in adults with type 2 diabetes, Innovent Biologics announced on Sept. 19, 2025 ^[1]. The Suzhou-based company said mazdutide is the world's first dual glucagon (GCG)/GLP-1 receptor agonist approved for blood sugar control in adults with type 2 diabetes, and that it now holds approval in China for two indications ^[1].

Mazdutide is not semaglutide (Ozempic, Wegovy, Rybelsus) or tirzepatide (Mounjaro, Zepbound). It is a mammalian oxyntomodulin analog that acts on two hormone receptors ^[1]. Like GLP-1 drugs, it promotes insulin secretion, lowers blood sugar and reduces body weight; the company says glucagon receptor activation may also raise energy expenditure and improve fat metabolism in the liver ^[1]. Innovent licensed mazdutide from Eli Lilly for development and commercialization in China ^[1].

The approval rests on two Phase 3 trials in Chinese adults with type 2 diabetes: DREAMS-1, which tested mazdutide alone, and DREAMS-2, which tested it against dulaglutide 1.5 mg in people whose blood sugar was not controlled on oral medication ^[1].

In DREAMS-1, at week 24, average HbA1c fell by 1.57 percentage points on mazdutide 4 mg, 2.15 points on 6 mg and 0.14 points on placebo. The share of participants reaching HbA1c below 7% was 68.6%, 87.4% and 10.7%, respectively. Average body weight fell 5.61%, 7.81% and 1.26%, and the share hitting both an HbA1c under 7% and at least 5% weight loss was 40.6%, 64.9% and 0% ^[1].

In DREAMS-2, at week 28, average HbA1c fell 1.69 points on mazdutide 4 mg, 1.73 points on 6 mg and 1.38 points on dulaglutide. HbA1c below 7% was reached by 71.2%, 74.2% and 62.1%. Average weight fell 7.31%, 9.24% and 2.86%, and the combined HbA1c and weight goal was met by 50.1%, 64.3% and 19.4% ^[1].

The company said mazdutide's safety profile matched earlier studies and other GLP-1 receptor agonists, with no new safety signals identified ^[1]. Injection-site device features described by the company include a hidden needle and single-use design ^[1].

China has about 140 million adults with diabetes, roughly one in four cases worldwide, a figure projected to reach 174 million by 2045 ^[1].

Why it matters for patients

Mazdutide is approved in China only. No US approval, US filing, or US launch date for mazdutide has been reported, so this approval does not change what is available to patients in the United States today ^[1].

The results add context for people comparing GLP-1-based medicines. Mazdutide works through two receptors rather than one, and the company reported larger average weight loss than dulaglutide 1.5 mg over 28 weeks in DREAMS-2 ^[1]. Those figures come from a trial in Chinese adults with type 2 diabetes and are not a head-to-head comparison against semaglutide or tirzepatide; two ongoing trials, GLORY-3 and DREAMS-3, are testing mazdutide against semaglutide, in obesity with fatty liver disease and in type 2 diabetes with obesity respectively ^[1]. Results from those have not been reported.

Two trial investigators quoted in the announcement described unmet need in China, where many patients with type 2 diabetes also have obesity, heart disease, fatty liver disease or kidney disease ^[1].

What happens next

The company lists seven Phase 3 mazdutide trials; GLORY-1, DREAMS-1 and DREAMS-2 have met their main goals, and four are ongoing ^[1]. Beyond those, Innovent says it has started or planned a Phase 3 trial in adolescents with obesity and new studies in metabolic dysfunction-associated steatohepatitis (MASH) and in heart failure with preserved ejection fraction (HFpEF) ^[1]. No timeline for those readouts, and no price or access details for the newly approved diabetes indication, were disclosed ^[1].