Innovent Biologics has unveiled Phase III (DREAMS-2) results for mazdutide, indicating superiority over dulaglutide in glycaemic control for type 2 diabetes (T2D) patients in China.
“With its potential to revolutionise T2D treatment, mazdutide’s success could not only reshape the landscape of diabetes therapeutics in China but also underscores the growing demand for innovative solutions amidst the escalating prevalence of T2D in the region,” says GlobalData.
Mazdutide is reportedly the only glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist to reach Phase III stage of development (China) for type 2 diabetes (T2D) globally.
DREAMS-2 (NCT05606913) Phase III study compared the efficacy and safety of mazdutide and dulaglutide in Chinese subjects with T2D, who have inadequate glycemic control with metformin monotherapy or combination therapy of metformin with other oral drugs. The primary endpoint was successfully met, showing the robust glucose-lowering efficacy of mazdutide. The key secondary endpoints showed mazdutide’s superior benefits in both glucose-lowering and weight loss.
According to GlobalData’s Pharmaceutical Intelligence Center, the number of diagnosed prevalent cases of T2D in China is expected to increase at an annual growth rate (AGR) of 2.21 per cent from 58.460,424 in 2023 to 63,342,654 in 2028.
Nelluri Geetha, Pharma Analyst at GlobalData, comments, “The increasing prevalence of type 2 diabetes mellitus (T2DM) in China has necessitated the discovery of more effective means to achieve glycemic control. Dual agonism at GLP-1R and GCGR could potentially enhance efficacy beyond monotherapies.”
Innovent Biologics entered into a licensing agreement with Eli Lilly and Company in August 2019 for the development and commercialization of the oxyntomodulin analog (OXM3), also known as mazdutide, in China.
Mazdutide will be the second drug from Innovent Biologics in Chinese metabolic disorders market, the first being Symbix (tafolecimab) approved for heterozygous familial hypercholesterolemia, hypercholesterolemia, and mixed dyslipidemia. Symbix is expected to generate global sales of $517 million by 2030.
Amongst the seven GLP-1R/GCGR dual agonists being developed globally from Phase I to Phase III stages of clinical development, PB-718 (Phase I) and mazdutide, are from China. Mazdutide is in Phase I clinical trials in the US and Phase II in Europe for T2D. Additionally, it is in the pre-registration stage in China for obesity treatment and is undergoing Phase II trials globally for the same indication.
As per GlobalData’s Pharmaceutical Intelligence Center, for Innovent Biologics, mazdutide is expected to generate global sales of $936 million by 2030.
Geetha concludes: “While global companies currently dominate the Chinese T2D market, the development of mazdutide by a Chinese company in China could potentially establish it as a leading treatment option for T2D. Following approval, mazdutide would open huge opportunities for Innovent to tap the obesity and T2D markets in China with well-planned commercial strategy.”