Gan & Lee inks third overseas out-licensing deal for its GLP-1 asset with Korea's JW Pharma, worth up to $81M

On April 8, 2026, Gan & Lee Pharmaceuticals (SSE: 603087) announced the signing of an exclusive licensing agreement with JW Pharmaceutical, a leading pharmaceutical company in South Korea. The two parties will collaborate on the clinical development, regulatory filing, and commercialization in South Korea of Bofanglutide Injection (R&D code: GZR18), a bi-weekly Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA) independently discovered and developed by Gan & Lee.

Under the terms of the agreement, JW Pharmaceutical will be granted the exclusive rights to develop and commercialize Bofanglutide Injection in South Korea. Gan & Lee Pharmaceuticals will receive a one-time, non-refundable upfront payment of USD 5 million. Additionally, Gan & Lee is eligible to receive milestone payments totaling USD 76.1 million, contingent upon research and development progress, regulatory approvals, and commercialization achievements. Following the product's commercial launch, Gan & Lee will also receive tiered royalties based on net sales. The total potential transaction value reaches up to USD 81.1 million (approximately RMB 560 million, excluding royalties).

This collaboration marks the third overseas out-licensing deal for Gan & Lee's Bofanglutide Injection, following previous partnerships in Latin America and India.

The primary highlight of Bofanglutide, as indicated in its product profile, is its status as a bi-weekly formulation.

In the GLP-1 therapeutic area, dosing frequency is a key variable influencing patient compliance. Currently, the market-leading medications, Semaglutide and Tirzepatide, are both administered once weekly. Bofanglutide extends this interval to once every two weeks, reducing the annual injection frequency by 50% compared to mainstream regimens. While this difference may appear straightforward, it is underpinned by sophisticated molecular design. Bofanglutide utilizes fatty acid acylation technology and shares 94% homology with the endogenous human GLP-1 molecule. By optimizing receptor affinity, it extends the half-life while mitigating gastrointestinal adverse reactions.

Clinical data provide robust support for these attributes. In a Phase IIb study presented at the 2025 ADA Annual Meeting, Bofanglutide demonstrated compelling results in patients with type 2 diabetes mellitus (T2DM). The 18mg bi-weekly dose group achieved a 2.28% reduction in HbA1c, and the 24mg once-weekly dose group achieved a 2.32% reduction, both outperforming the 1.6% reduction observed in the Semaglutide group. In treatment-naïve patients managed with lifestyle intervention, the 18mg bi-weekly dose group achieved a 2.98% reduction in HbA1c.

The weight-loss data are equally noteworthy. A Phase IIb weight-loss study disclosed in November 2024 showed that subjects in the 48mg bi-weekly group experienced a 17.29% reduction in body weight over 30 weeks, comparable to the 17.78% reduction in the 24mg once-weekly group, while the placebo group experienced only a 0.99% reduction. In the 48mg bi-weekly group, 97.8% of subjects achieved a body weight reduction of ≥5%.

Currently, Phase III clinical trials for Bofanglutide are being broadly initiated. In China, the GRADUAL-2 study targeting obesity/overweight has been launched as a head-to-head trial against Semaglutide, with plans to enroll 471 subjects. In the United States, a Phase II study of Bofanglutide is also being conducted as a head-to-head comparison with Tirzepatide, making it the world's first single-target GLP-1RA to challenge the weight-loss efficacy of Tirzepatide.

Furthermore, Gan & Lee Pharmaceuticals is developing an oral formulation of Bofanglutide. The GZR18 tablet utilizes SNAC absorption enhancer technology. Phase I data indicated that after two weeks of treatment with a 60mg dose, healthy subjects achieved a mean body weight reduction of 4.16% from baseline.

In summary, the product logic for Bofanglutide has become clear: it achieves differentiation by extending the dosing interval and aims to demonstrate non-inferior or superior efficacy compared to existing standard-of-care therapies through head-to-head clinical data. In the increasingly crowded GLP-1 therapeutic area, this positioning of "reduced dosing frequency without compromised efficacy" represents a pragmatic and commercially viable path forward.

The overseas out-licensing cadence of Bofanglutide reflects Gan & Lee Pharmaceuticals' strategic assessment: rather than struggling in the intensely competitive domestic Chinese market, it is preferable to leverage the product's advantages to establish a presence in the global commercial landscape.

The competitive landscape for the GLP-1 market in China has become extremely intense. The core compound patent for Semaglutide expired on March 20, 2026, and a wave of generic drug manufacturers is now gathering. Currently, over 20 companies have entered the competition. On pricing, the listed price for Semaglutide in Sichuan has been reduced from RMB 1,893 to RMB 987, a decrease of nearly 50%. Tirzepatide has also experienced a direct price reduction of up to 80%. Such aggressive price reductions by originator pharmaceutical companies have significantly lowered the psychological payment threshold for the target patient population, while the profit margins available to latecomers are rapidly narrowing.

Gan & Lee Pharmaceuticals' response to this situation is globalization. The first destination for Bofanglutide was Latin America, the second was India, and the third is South Korea. This collaboration with JW Pharmaceutical targets South Korea, a mature market in the Asia-Pacific region. According to data from Grand View Research, the South Korean GLP-1RA market size was USD 526 million in 2025 and is projected to increase to USD 1.6 billion by 2033. The South Korean market is characterized by high acceptance of innovative drugs and strong patient purchasing power, making it a strategic gateway for multinational pharmaceutical companies entering the East Asian market. JW Pharmaceutical, founded in 1945, is a leading pharmaceutical company in South Korea with deep commercialization capabilities in the field of metabolic diseases.

It is worth noting that Gan & Lee Pharmaceuticals' globalization strategy can be described as leveraging partners' strengths. The company selects local partners with established market access channels and regulatory expertise, advancing through a light-asset model comprising upfront payments, milestone payments, and tiered royalties. This model reduces the cost and risk of entering overseas markets while retaining the product's right to share in the value distribution across the global value chain.

Of course, the overseas commercialization of Bofanglutide still faces challenges. Its Phase III clinical trials have not yet been completed, and there remains a time window before market approval. During this period, Eli Lilly's retatrutide (a triple-target agonist with 28.7% weight loss in Phase III) and next-generation products from Novo Nordisk are on the path to market. By the time Bofanglutide is actually launched, whether the bi-weekly dosing regimen will still constitute a sufficiently robust moat remains a question to be answered in due course. Naturally, if Gan & Lee Pharmaceuticals successfully launches a once-monthly novel agent in the future, its competitiveness would be further enhanced.

Approximately one week ago, Eli Lilly's oral GLP-1 weight-loss drug Foundayo (orforglipron) received FDA approval, with a patient out-of-pocket price of USD 149 per month in the United States. Upon this news, a view emerged within the industry that the two giants have already divided the market, and that the window of opportunity for the GLP-1 target has closed.

On the surface, this seems to suggest that the pathway for China's domestic novel drugs to achieve market entry has been blocked. However, when examining this licensing deal by Gan & Lee Pharmaceuticals within a longer timeframe, this judgment warrants further inquiry: what kind of window are we really talking about? Is it a "me-too window" or a "differentiation window"?

At present, the competitive dynamics in the GLP-1 therapeutic area have fundamentally shifted. In 2023, developing a GLP-1 drug with acceptable safety and efficacy (approximately 10% weight reduction without inducing vomiting as a side effect) was sufficient to be considered qualified. By 2024, the requirement for weight reduction had increased to 15%. In 2026, the competitive landscape has evolved into the convergence of multi-dimensional factors: mild side effects, weight reduction exceeding 15%, affordable pricing, an oral route of administration as a preference, and lower dosing frequency. The barriers created by the convergence of these five factors are so high, and the combination so difficult to achieve, that they are insurmountable for average followers.

Under this new logic, the survival pathways for China's domestic GLP-1 enterprises have been renewed.

Pathway One: Extreme differentiation, exemplified by bi-weekly formulations. This is precisely the logic behind Bofanglutide — not pursuing the number of targets, but creating patient value by extending the dosing interval. In chronic disease medications such as GLP-1s, compliance itself is an integral part of efficacy. A bi-weekly dosing regimen holds both clinical and commercial value for patients with obesity and diabetes who require long-term medication.

Pathway Two: Maintaining cost leadership. Following the patent expiration of Semaglutide, generic drugs are expected to drive prices down to the range of RMB 100-200 per month. The scale of this market will persist, albeit with thinner profit margins, making it suitable for enterprises with large-scale manufacturing capabilities and channel advantages. As a leading insulin manufacturer, Gan & Lee Pharmaceuticals possesses the cost-control capabilities for large-scale biologics production, representing a potential advantage for the company.

Pathway Three: Targeting global emerging markets. The GLP-1 market in Europe and the United States has been highly penetrated by Novo Nordisk and Eli Lilly. However, penetration rates remain relatively low in emerging markets such as Asia-Pacific, Latin America, and the Middle East. Gan & Lee Pharmaceuticals' three licensing deals in Latin America, India, and South Korea exemplify the execution of this pathway.

Pathway Four: Next-generation technology pipeline. Fat reduction with muscle preservation, oral weekly formulations, gene therapy, and other approaches represent longer-term differentiation directions. Gan & Lee Pharmaceuticals has also established a pipeline for an oral formulation, which is currently in Phase I. Furthermore, Gan & Lee is expanding its indications. The global development of Bofanglutide for three proposed indications — obesity/overweight, type 2 diabetes mellitus (T2DM), and obstructive sleep apnea (OSA) — has advanced into the critical Phase III clinical stage.

The window is shifting, and the rules are changing. Gan & Lee Pharmaceuticals' total potential transaction value of USD 80 million may appear modest compared to the multibillion-dollar mergers and acquisitions of multinational corporations. Nevertheless, through differentiated advantages and a global licensing network, the company has avoided head-on competition and charted a commercial pathway that can serve as a reference for China's domestic novel drugs.