On October 27, Innovent Biologics announced that its self-developed GCG/GLP-1 dual receptor agonist, “Mashidu-tide,” successfully met the primary endpoint in the pivotal Phase III clinical study DREAMS-3. This study is highly significant, as it is the first global Phase III trial directly comparing a domestically produced drug with Novo Nordisk’s “Drug King” semaglutide.

The results showed that among Chinese patients with type 2 diabetes and obesity, Mashidu-tide achieved statistically significant advantages on the composite efficacy endpoint of blood sugar control and weight management. Specifically, nearly half (49.7%) of patients treated with Mashidu-tide simultaneously reached blood sugar targets and lost more than 10% of body weight—a proportion more than twice that of the semaglutide group (21.0%).

This is not only a clinical victory but also a strong market signal: the GLP-1 market long dominated by international giants like Novo Nordisk and Eli Lilly now has a breach. Chinese pharmaceutical companies have proven capable of developing innovative drugs that match or even surpass global blockbuster products in core efficacy, laying a solid foundation for China to claim a voice in the huge metabolic disease market.

Semaglutide has long dominated the obesity and diabetes market.

Head-to-Head Trial Confirms Advantage of Chinese Drug

In the field of innovative drugs, head-to-head clinical trials are considered the “gold standard” for evaluating drug value. These trials require direct comparison with current standard-of-care or a recognized “star drug,” producing the most convincing but also riskiest results.

The DREAMS-3 trial of Mashidu-tide was designed closely around the clinical needs of Chinese patients. The study enrolled 349 early-stage type 2 diabetes patients with obesity, representing a typical group facing treatment challenges in China—patients whose blood sugar and weight remained suboptimal despite lifestyle interventions.

The primary endpoint was set as a composite measure of HbA1c <7.0% and ≥10% weight reduction from baseline, directly targeting the core challenge of “diabesity” management. The results clearly demonstrated Mashidu-tide’s comprehensive superiority: nearly half of patients achieved this stringent composite endpoint, and for individual endpoints, the Mashidu-tide group saw an average HbA1c reduction of 2.03% and weight loss of 10.29%, both significantly better than the semaglutide group (1.84% and 6.00%, respectively). Additionally, Mashidu-tide showed greater potential in improving fasting glucose, waist circumference, systolic blood pressure, and other cardiometabolic risk factors.

The clinical significance of this data is profound. Professor Ji Linong, Director of the Endocrinology Department at Peking University People’s Hospital, pointed out that in China, the population of type 2 diabetes patients with obesity is rapidly growing, with more difficult blood sugar control and higher cardiovascular risk. Therefore, treatments that can simultaneously and effectively manage both blood sugar and weight are crucial for improving long-term outcomes. As a GCG/GLP-1 dual receptor agonist, Mashidu-tide’s dual mechanism may offer a “1+1>2” synergistic effect, showing unique advantages in energy expenditure and lipid metabolism regulation.

Breaking the Myth that Imported Drugs Are Superior

Equally important, the trial’s success helps break the “trust barrier” that has long hindered Chinese innovative drugs. Historically, despite rapid domestic R&D progress, doctors and patients often preferred imported products with extensive international clinical data and long-term market validation.

Mashidu-tide provides the highest level of evidence-based medicine through rigorous Phase III head-to-head trials, giving clinicians a clear and reliable domestic option. Its favorable safety and tolerability profile further alleviates market concerns. No new safety signals were observed in the trial, and discontinuation rates due to adverse events were low, clearing the path for large-scale clinical use.

From a market perspective, Mashidu-tide’s localization is one of its core competitive advantages. Its clinical development was entirely based on Chinese patient populations, meaning its dosing, administration, and adverse event profile may better align with the physiological characteristics and treatment habits of Chinese patients. This “tailor-made” adaptation, combined with confirmed efficacy, gives it unique affinity and competitiveness in the Chinese market.

Chinese Innovative Drugs Enter the Billion-Dollar Track

Mashidu-tide’s clinical breakthrough comes in a rapidly growing golden market. GLP-1 drugs, due to their outstanding efficacy in diabetes, obesity, and a range of cardiometabolic diseases, are widely considered a core driver of the global pharmaceutical market over the next decade.

According to Morgan Stanley and other institutions, by 2030 the global market for obesity and metabolic disease drugs will surpass $100 billion, with GLP-1 products as the dominant force. Currently, the market shows a typical “dual oligopoly” pattern: Novo Nordisk dominates with semaglutide products, Eli Lilly with tirzepatide, collectively controlling most of the market and industry influence.

However, the market under the giants is not monolithic, especially in China. China has the largest population of diabetes patients and a vast overweight and obese population, representing an enormous untapped market. Imported drugs often face high prices and unstable supply, creating a strategic window for domestic companies. The timely emergence of Mashidu-tide seizes this opportunity. As the first globally approved GCG/GLP-1 dual receptor agonist, it has already secured both weight management and type 2 diabetes indications, paving the way for commercialization.

To stand firm in this competitive landscape, Innovent Biologics has chosen a differentiated breakthrough strategy.

Mashidu-tide has completed seven Phase III trials and has initiated or planned studies for broader indications, including adolescent obesity, metabolic-associated fatty liver disease, and heart failure. Notably, the company plans a high-dose head-to-head study against Eli Lilly’s tirzepatide, demonstrating its determination to compete directly with top rivals in the high-end market. By continuously expanding clinical boundaries, Mashidu-tide aims to build a multi-metabolic disease product ecosystem, establishing a deep technological and market moat.

At present, Mashidu-tide’s success injects a strong boost into China’s biotechnology industry. It demonstrates that with the combined support of capital, talent, and policy, Chinese innovation can occupy a place at the highest level of the global pharmaceutical arena.

Editor: Zhongxiaowen