This breakthrough could hold immense promise to transform T2D treatment dynamics. Mazdutide's triumph not only signals a potential paradigm shift in diabetes therapy within China but also underscores the rising necessity for inventive approaches amidst the surging prevalence of T2D in the region, according to data and analytics firm GlobalData.
It is believed that Mazdutide is currently the only glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist to reach phase 3 stage of development in China, making it a unique contender in the global landscape T2D.
The phase 3 study known as DREAMS-2 aimed to evaluate the effectiveness and safety of mazdutide versus dulaglutide among Chinese individuals with T2D.
These participants had insufficient glycemic control despite receiving either metformin alone or a combination of metformin with other oral medications.
The primary objective was achieved, demonstrating mazdutide's strong efficacy in reducing glucose levels. Additionally, significant secondary endpoints highlighted mazdutide's superiority in both glucose reduction and weight loss benefits.
According to GlobalData, the number of diagnosed prevalent cases of T2D in China is expected to increase at an annual growth rate (AGR) of 2.21% from 58.460,424 in 2023 to 63,342,654 in 2028.
Nelluri Geetha, pharma analyst at GlobalData, said: “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.”
In 2019, Innovent Biologics entered into a licensing agreement with Eli Lilly 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 1 to phase 3 stages of clinical development, PB-718 and mazdutide, are from China.
Mazdutide is in phase 1 clinical trials in the US and phase 2 in Europe for T2D. Additionally, it is in the pre-registration stage in China for obesity treatment and is undergoing phase 2 trials globally for the same indication.
The treatment is expected to generate global sales of $936 million by 2030, GlobalData forecasts.
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.”