Gan & Lee's Monthly Shot Aims to Redefine the Weight-Loss Drug Market

BEIJING, China – November 27, 2025 – In a strategic move poised to disrupt the burgeoning global weight-management market, Chinese drugmaker Gan & Lee Pharmaceuticals has initiated a pivotal Phase 3 clinical study for a once-monthly obesity treatment. The trial, dubbed GRADUAL-3, will evaluate bofanglutide, a novel GLP-1 receptor agonist, signaling a direct challenge to the weekly injection regimens of current market titans like Novo Nordisk's Wegovy and Eli Lilly's Zepbound.

This development is more than just another entry into a crowded field; it represents a calculated bet on a crucial, often-overlooked factor in chronic disease management: patient adherence. By aiming to reduce the injection frequency from 52 times a year to just 12, Gan & Lee is positioning convenience and sustainability as a primary competitive advantage in a market projected to swell from $52 billion in 2024 to over $186 billion by 2032.

The High-Stakes Bet on Adherence

For the millions of individuals managing obesity, the efficacy of GLP-1 drugs is transformative. However, the reality of long-term treatment involves a commitment to regular self-injections, which can lead to so-called "treatment fatigue." Industry analysts and medical experts widely agree that simplifying this regimen is a critical frontier for innovation.

The GRADUAL-3 study, registered under CTR20254659, is designed specifically to address this challenge. The 24-week trial will assess if the once-monthly bofanglutide injection can effectively maintain weight loss achieved through prior treatment. Success in this study could validate the drug as a more sustainable long-term solution, potentially mitigating the common issue of weight regain when patients struggle to keep up with weekly schedules. By reducing the burden of treatment, a monthly option could significantly improve quality of life and long-term health outcomes.

"The clinical and commercial significance of a once-monthly GLP-1 cannot be overstated," noted one pharmaceutical market analyst. "While efficacy is paramount, the real-world winner in a chronic care market is often the drug that integrates most seamlessly into a patient's life. A monthly dose is a powerful differentiator that could capture a significant patient population seeking less frequent intervention."

Taking on the Titans in a Clinical Gauntlet

Gan & Lee is not shying away from direct confrontation with established leaders. The company's ambitious GRADUAL clinical program, which plans to enroll over 1,000 participants across China, includes direct head-to-head comparisons that demonstrate a bold confidence in bofanglutide's potential.

The most notable of these is the GRADUAL-2 study, which pits bofanglutide directly against the 2.4 mg dose of semaglutide (Wegovy). This trial is the first of its kind globally to compare a new GLP-1 candidate with Wegovy in Chinese adults, providing a clear benchmark for its efficacy and safety.

Furthermore, Gan & Lee has expanded its competitive sights to the U.S. market, the largest segment for obesity drugs. In a separate Phase 2 trial (NCT06737042), a bi-weekly formulation of bofanglutide is being tested against Eli Lilly's powerful dual-agonist tirzepatide (Zepbound). This head-to-head strategy in the world's most lucrative market underscores the company's global ambitions and its belief that bofanglutide can compete on both efficacy and convenience.

This aggressive clinical strategy is supported by Gan & Lee's solid financial footing. The company reported a 16.77% increase in revenue and a substantial 80.75% rise in earnings in 2024, providing the capital necessary to fund these extensive and costly late-stage trials. This financial strength is crucial as it navigates the complex and expensive path toward potential regulatory approvals from China's NMPA and, eventually, the U.S. FDA and Europe's EMA.

Navigating a Crowded and Evolving Battlefield

Bofanglutide enters a market characterized by intense innovation and escalating efficacy benchmarks. Novo Nordisk and Eli Lilly have set a high bar. Clinical trials have shown Zepbound can lead to an average body weight reduction of over 20%, while Wegovy achieves around 17.5%. The next wave of treatments promises even more dramatic results, with Eli Lilly's investigational triple-agonist, retatrutide, showing a staggering 24.2% weight loss in Phase 2 trials.

In this context, Gan & Lee's bofanglutide must prove it is not only convenient but also clinically effective. While the company has reported "outstanding weight-loss and glucose-lowering effects" in earlier studies, the results from its head-to-head trials will be the ultimate litmus test. Its unique value proposition may lie in finding a sweet spot: offering clinically meaningful weight loss with a vastly superior dosing schedule that appeals to a broad segment of the market.

The competitive landscape is also expanding beyond injectables. The development of effective oral GLP-1s, such as Eli Lilly's orforglipron and Novo Nordisk's oral semaglutide, presents another front in the battle for patient preference. Gan & Lee's focus on a long-acting injectable places it in a distinct, and potentially highly valuable, niche.

As the industry pushes beyond weight loss to secure approvals for related conditions like cardiovascular disease, sleep apnea, and MASH, the 'comprehensive metabolic benefits' touted for bofanglutide will also be critical. Demonstrating a holistic impact on patient health will be key to securing a strong position in the future of metabolic medicine. Gan & Lee's pursuit of a once-monthly GLP-1 is a clear signal that the next chapter in the obesity drug race will be defined not just by how many pounds are lost, but by how sustainably that success can be maintained.