Mazdutide
(IBI362)

The Discovery

The Asian Opportunity

A Global Crisis Hits Home

The obesity epidemic was growing fastest in Asia. China's population of 1.4 billion people faced an explosion of weight-related disease. Between 2000 and 2015, obesity rates among Chinese adults tripled. Type 2 diabetes became the nation's leading metabolic disorder, affecting over 110 million people by 2018.

Meanwhile, Western pharmaceutical companies dominated GLP-1 drug development. Novo Nordisk had liraglutide. Novo Nordisk was preparing to launch semaglutide (Ozempic). Eli Lilly was developing tirzepatide. These companies moved slowly because they had massive research pipelines with hundreds of other drugs in development. Each therapy took 10-15 years to move from concept to approval in the United States.

Innovent Biologics, founded in 2011 by Michael Yu, saw a different opportunity. China's healthcare system wanted innovation, and China's regulatory agency — the National Medical Products Administration (NMPA) — was becoming faster and more efficient at approving breakthrough medicines. If a Chinese biotech could develop something faster than global giants, it could win approval in China years before the West. And then Eli Lilly could take that approved medicine global.

The Breakthrough

The Dual-Target Bet

A Strategy Nobody Had Approved Yet

In 2018, Innovent Biologics made a bold scientific and strategic decision. Instead of copying what Western competitors were doing — developing single-target GLP-1 agonists — they would develop something more powerful: a peptide that activated both GLP-1 and glucagon receptors at the same time.

The science was based on emerging evidence that combining two gut hormones could produce better metabolic effects than either one alone. Glucagon naturally increases energy expenditure and fat burning. GLP-1 reduces appetite and lowers blood sugar. Why not activate both simultaneously?

Dr. Lei Qian's research team began screening thousands of peptide sequences. Each candidate had to bind strongly to both receptors while being stable enough to be manufactured and formulated as an injection. The team tested amino acid sequences, tested different chain lengths, tested different attachment points for stability-enhancing modifications. By 2019, they had identified a lead candidate: IBI362, which would become known as mazdutide.

That same year, Innovent announced a collaboration with Eli Lilly to co-develop mazdutide. Lilly provided resources and clinical trial expertise; Innovent kept control of the Chinese regulatory pathway. This partnership gave Innovent the financial firepower to run rapid, rigorous Phase 1 and Phase 2 trials.

The Trials

The Race Accelerates

Clinical Proof and Competition Looms

Phase 1 trials in 2020-2021 showed that mazdutide was safe and well-tolerated. Early weight loss data was impressive. At higher doses, patients lost up to 6.4% of their body weight in just 12 weeks — better than expected for this early phase. Innovent moved forward aggressively.

The GLORY Phase 3 trial program launched in China. GLORY-1 would test mazdutide in patients with obesity. The trial enrolled over 500 patients across multiple Chinese centers, with Dr. Wenying Yang as principal investigator. The primary endpoint was weight loss at 52 weeks.

But competition was heating up. Semaglutide and tirzepatide were also filing for approval in China. The race was no longer just about good science — it was about speed and execution. Innovent had one advantage: they could move through China's regulatory system faster than multinational companies with complex global approval timelines.

In January 2024, GLORY-1 results were announced: mazdutide-treated patients lost an average of 15-18% of their body weight, with some achieving over 20% loss. All primary and secondary endpoints were met. The data was strong enough that Innovent immediately submitted a New Drug Application (NDA) to China's NMPA in February 2024 for chronic weight management.

Simultaneously, the DREAMS Phase 3 trial program was recruiting patients with type 2 diabetes, testing whether mazdutide could also serve as a diabetes treatment. Dr. Yang expanded her clinical leadership to oversee these trials as well.

The Crisis

Victory and Vindication

The World's First Dual-Agonist Approval

For nearly two decades, drug companies had pursued single-target strategies. GLP-1 alone, GIP alone, glucagon alone. Each worked, but each had limitations. Mazdutide proved that the dual-target approach was not just possible — it was superior.

In June 2025, China's NMPA approved mazdutide for chronic weight management, making it the first dual GLP-1/glucagon receptor agonist approved anywhere in the world. Western regulatory agencies had not yet approved any dual-agonist in this class. By moving fast in China, Innovent Biologics had beaten Novo Nordisk, Roche, Amgen, Merck, and all other global competitors to this breakthrough.

The significance was historic. For the first time, a Chinese biotech company had developed a novel drug class entirely independently and brought it to market before global giants. It proved that Asia's scientific innovation capability had matured. Innovent Biologics, listed on Hong Kong Stock Exchange (HKEX: 01801), demonstrated that Chinese companies could compete at the highest level of biotech.

In September 2025, just three months after the obesity approval, China's NMPA approved mazdutide for type 2 diabetes based on the DREAMS trial results. Patients with diabetes saw improvements in blood sugar control with the added benefit of weight loss — a powerful combination.

Meanwhile, Eli Lilly's global Phase 2 trials continue in the United States and Europe. If those trials succeed, mazdutide could become available to patients worldwide by 2027-2028, potentially extending Innovent's innovation lead even into global markets.

The Legacy

The Global Future

From China to the World

Mazdutide represents a turning point in the global pharmaceutical industry. For decades, the United States and Europe controlled drug development. Now, China is not just manufacturing generic medicines — it is inventing new drug classes.

The approvals in China are just the beginning. Eli Lilly is running Phase 2 trials in the US and Europe. If those trials succeed, regulatory submissions could follow in 2026-2027. The US FDA and European Medicines Agency will evaluate whether mazdutide offers advantages over existing GLP-1 and tirzepatide medicines. Early evidence suggests it might — the dual-receptor activation provides weight loss and metabolic improvements that single-target drugs cannot match.

Innovent Biologics is also expanding mazdutide's clinical development. In December 2025, the company began a Phase 1b trial in Chinese adolescents with obesity — testing whether this breakthrough can help younger patients before they develop type 2 diabetes and other complications.

The competitive landscape is shifting. Roche is developing a dual GLP-1/GIP agonist. Novo Nordisk is testing triple-hormone combinations. But mazdutide is already approved and in patients' hands in China. That head start — being five years ahead of competitors in real-world use — could define the market for the next decade.

Most importantly, mazdutide proves that breakthroughs can come from anywhere. They don't have to originate in Boston or San Francisco. A young company in Suzhou can dream as big as the giants, execute faster, and reach patients first. The future of medicine is no longer dominated by a single geography — it belongs to whoever can combine excellent science with rapid execution.