As global demand for weight loss drugs soars, China is preparing to approve its first domestically developed dual target treatment for obesity.

The drug, named mazdutide, is pending market approval following the successful completion of phase 3 local clinical trials, and could launch later this year. Details of the clinical trials were published online in The New England Journal of Medicine on May 24.

Unlike its mainstream competitors already on the market, such as semaglutide, better known globally as Ozempic, which targets glucagon-like peptide-1 (GLP-1) receptors and suppresses appetite by mimicking hormones released in the gut in response to eating, mazdutide also targets glucagon receptors (GCGR), simultaneously boosting metabolism.

Innovent Biologics, a biotech company headquartered in Jiangsu province, eastern China, developed the drug and funded the clinical trial.

The clinical trial was led by Professor Ji Linong, chief of endocrinology at Peking University People’s Hospital, in Beijing, in collaboration with 15 other endocrinology and cardiology professors from hospitals across the country.

The trial enrolled 610 Chinese obese or overweight participants with at least one obesity-related complication.

Results showed that a once-weekly 4 mg or 6 mg injection of mazdutide over 32 weeks significantly reduced body weight. Nearly half of the participants in the 6 mg group experienced a weight loss of at least 15%.

The most frequently reported side effects were mild to moderate gastrointestinal issues.

“For years, global obesity treatment guidelines have been based primarily on data from white populations, which may not fully apply to Asian patients,” Professor Ji told domestic media, not specifying how Asian populations may differ from other races. “There is an urgent need for China-specific evidence to guide weight management in this population.”

An editorial published in the same issue of the journal commented that the makeup of the trial group — generally younger and with a higher prevalence of liver disease compared to participants in most international obesity drug trials — “suggests either a shifting focus toward earlier preventive treatment for obesity or a phenotype representative of contemporary obesity in China.”

“This information serves to remind us that obesity-related conditions and complications may occur in different ethnic populations at different ages and with different manifestations that remain responsive to intervention,” it continued.

By 2050, projections indicate that more than half of the world’s adult population will be overweight or obese.

That figure is due to be most prominent in China, where the overweight or obese population is expected to reach 630 million.

In March, China’s National Health Commission announced plans to establish multidisciplinary “weight management clinics” in hospitals nationwide, aimed at helping patients lose weight safely under medical supervision.

Professor Ji noted that given that obesity is a metabolic disease, the new drug could serve as a “weapon” for such clinics to treat it beyond promoting everyday methods such as nutrition and exercise.

Both global and domestic pharmaceutical companies are racing to tap into China’s surging demand for weight loss and diabetes treatments, a market projected to reach 14.9 billion yuan ($2.1 billion) by 2030.

Leading the current market are GLP-1 monotherapy drugs, such as semaglutide, which, in addition to regulating blood sugar levels to treat Type 2 diabetes, has demonstrated a reduction in body weight of up to 15% over a 68-week treatment cycle.

Research efforts are now shifting toward multi-target therapies, with mazdutide considered one of the most promising next-generation contenders to semaglutide.

According to Professor Ji, the addition of the GCGR target enhances metabolic benefits, most notably reducing liver fat, as well as lowering blood pressure, blood lipids, and other cardiovascular risk markers.

In August 2019, U.S. pharmaceutical giant Eli Lilly, a global leader in diabetes treatments, licensed Innovent Biologics to develop and commercialize the key molecule used in mazdutide in China.

The collaboration reflects a common model in the biopharmaceutical industry, in which multinational drugmakers provide early-stage assets and molecular design, while Chinese partners lead local clinical development and commercialization efforts.

Editor: Tom Arnstein.

(Header image: VSI/VCG)