Innovent Biologics’ glucagon-like peptide-1 receptor agonist (GLP-1RA) has outperformed Novo Nordisk’s semaglutide in a late-stage, head-to-head study in type 2 diabetes (T2D) with comorbid obesity.
During the Phase III DREAMS-3 trial (NCT06184568), Innovent’s drug, Xinermei (mazdutide), met its primary endpoint, offering statistically significant improvements to the proportion of patients achieving HbA1c values of under 7%, as well as more than 10% body weight reduction.
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At week 32, 48% of the patients in the Xinermei arm achieved this milestone while 21% experienced the same outcome in the semaglutide cohort.
In addition, the mean HbA1c reduction from baseline in the Xinermei group was 2.03% while patients in the semaglutide arm experienced a 1.84% drop. The weight reduction from baseline was also higher for those given Xinermei, with the average percentage weight loss being 10.29%, as opposed to the 6% seen in patients randomised to semaglutide.
Xinermei’s safety and tolerability profile was consistent with previous studies, with the most common adverse events (AEs) being gastrointestinal. Of the treatment-emergent adverse events (TEAEs), most were classed as mild or moderate.
The positive results of the DREAMS-3 study will be welcome news for Innovent, which acquired the rights to Xinermei in China from the drug’s creator, Eli Lilly, in 2019.
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By GlobalDataAfter conducting a string of Phase III trials involving Xinermei on home turf, Innovent secured approval from the National Medical Products Administration (NMPA) for the drug in China. It is now available to patients who are overweight or obese and have one weight-related comorbidity such as high blood pressure.
This approval was based on the positive results of a string of Phase III studies, including the Phase III GLORY-1 trial (NCT05607680) in obesity and the Phase III DREAMS-2 study (NCT05606913) in T2D.
Serving unmet needs in T2D
According to Linong Ji, professor of medicine at the Peking University People’s Hospital and principal investigator of the DREAMS-3 trial, an increasing proportion of patients with T2D also have comorbid obesity.
Ji stated: “Patients with T2D and obesity experience more challenging glycaemic control, along with a significant increase in overall cardiovascular disease risk.”
This means that treatment strategies that effectively address blood glucose levels and facilitate weight loss can improve clinical outcomes in this patient population.
Due to its capacity to fulfil unmet needs in this patient population, a patient-based forecast from analysts at GlobalData estimates that Xinermei will become a blockbuster seller on the Chinese market, making $1.1bn for Innovent in 2030.
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However, the drug may have to compete with other drugs in the late-stage pipeline, such as Sciwind Biosciences’ GLP-1-targeting ecnoglutide, which is currently in the pre-registrational phase. According to Reuters, Sciwind CEO Pan Hai is also planning to license the drug in the US.
Jiangsu Hengrui Pharmaceuticals’ HRS9531, a dual gastric inhibitory polypeptide (GIP) and GLP-1RA, also displayed strong efficacy in a Phase III trial, triggering a weight loss of at least 20% in 44.4% of patients. The company will now likely file for the drug’s approval in the Chinese market.
Meanwhile, analysts predict that the wider market is poised for significant growth, with a report by GlobalData estimating that China’s obesity market will appreciate in value by a compound annual growth rate (CAGR) of 22.36%, reaching a value of $7.539bn by 2030.
