BEIJING and BRIDGEWATER, N.J., April 9, 2026 /PRNewswire/ -- Gan & Lee Pharmaceuticals (hereinafter referred to as "Gan & Lee", SSE: 603087) announced the signing of an exclusive licensing agreement with JW Pharmaceutical, a leading pharmaceutical company in South Korea. Under the agreement, the two parties will collaborate on the clinical development, regulatory filing, and commercialization in South Korea of Bofanglutide Injection, a bi-weekly (once every two weeks) Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA) independently discovered and developed by Gan & Lee.

Strategic Alliance: By Leveraging JW's Strengths in R&D and Commercialization in South Korea, Gan & Lee Will Establish a Strong Commercial Footprint in South Korea's High-Potential Metabolic Disease Market 

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 (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. According to data from Grand View Research, the GLP-1RA market in the Asia-Pacific region reached USD 5.47 billion in 2025 and is projected to grow to USD 16.95 billion by 2033, representing a compound annual growth rate (CAGR) of 14% ^[1], making it one of the fastest-growing regions globally. Currently, the treatment penetration rate of GLP-1 drugs remains extremely low, indicating massive growth potential. As a mature market in the Asia-Pacific region, South Korea's GLP-1RA market size reached USD 526 million in 2025 and is expected to increase to USD 1.6 billion by 2033 ^[2]. With its high acceptance of innovative drugs and strong patient purchasing power, the South Korean market has become a strategic foothold for multinational pharmaceutical companies entering East Asia. This collaboration marks another key step in the rapid global expansion of Gan & Lee's differentiated bi–weekly GLP–1RA, Bofanglutide.

Steady Progress in Global Phase III Clinical Trials; Bi-weekly Dosing Regimen Significantly Enhances Patient Compliance

Currently, as the world's first bi-weekly GLP-1RA to enter Phase III clinical research, Bofanglutide has advanced into the critical Phase III stage of its global development for three proposed indications: obesity/overweight, type 2 diabetes mellitus (T2DM), and obstructive sleep apnea (OSA). Existing clinical data demonstrate that Bofanglutide can effectively reduce body weight and blood glucose levels while comprehensively improving other metabolic parameters, yielding overall metabolic benefits. Its safety and tolerability profiles are consistent with other GLP-1RA class therapies. The bi-weekly dosing regimen further reduces the annual number of injections by 50% compared to mainstream once-weekly GLP-1RAs. This is anticipated to substantially boost patient adherence, offering a more convenient treatment option for the long-term, effective management of metabolic diseases.

As the global burden of metabolic diseases continues to rise, GLP-1 therapies are encountering tremendous market opportunities. South Korea, as one of the world's key pharmaceutical markets, exhibits a robust demand for innovative diabetes  and weight-loss therapies. This collaboration will effectively address the clinical and commercial needs of the South Korean market for highly efficacious and convenient treatment regimens.

"This partnership with JW Pharmaceutical marks another pivotal step in the globalization strategy for Bofanglutide," stated Dr. Zhi Li, Chief Business  Officer of Gan & Lee Pharmaceuticals. "GLP-1 therapies are reshaping the global treatment landscape for metabolic diseases. The convenience of Bofanglutide's bi-weekly dosing and its compelling clinical benefits will help address the unmet medical needs of South Korean patients. With over 80 years of experience, JW brings deep development and commercial expertise in metabolic diseases—a key factor in our decision to partner with JW."

Young-sub Shin, CEO of JW Pharmaceutical, commented: "This agreement represents a significant milestone in expanding our product portfolio within the rapidly growing therapeutic area of metabolic diseases, particularly diabetes and obesity. JW Pharmaceutical will leverage its established expertise in clinical development and regulatory execution, remaining committed to advancing the development and commercialization of Gan & Lee's Bofanglutide in South Korea, thereby bringing innovative treatment options to South Korean patients."

About Bofanglutide

Bofanglutide Injection (GZR18), independently developed by Gan & Lee Pharmaceuticals, is a bi-weekly administered GLP-1RA designed for the treatment of obesity/overweight, type 2 diabetes mellitus (T2DM), and other metabolic diseases. Clinical research data indicates that Bofanglutide can effectively reduce body weight and lower blood glucose levels, while comprehensively improving other metabolic parameters. With safety and tolerability profiles consistent with the GLP-1RA class of drugs, it is poised to potentially become the world's first commercially available bi-weekly GLP-1RA. Currently, the global development of Bofanglutide Injection has entered the Phase III clinical research stage.

About JW Pharmaceutical

Founded in 1945, JW Pharmaceutical Corporation has been a leader in Korea's therapeutic pharmaceutical market, guided by its founding principles of respect for life and a spirit of challenge. With a robust portfolio of original medicines, JW Pharmaceutical has focused on innovative drug discovery and development since the establishment of its Central Research Institute in 1983 and the C&C Research Laboratories in 1992. Through advanced research technologies, including its AI-based drug discovery and development platform, JWave, the company has built a strong pipeline in areas such as oncology, immunology, and regenerative medicine. JW Pharmaceutical also actively pursues diverse research initiatives aligned with global trends through open innovation. JW Pharmaceutical Corporation is listed on the Korea Exchange under the ticker "001060."

References:

1. Grand View Research. (2026). Asia Pacific GLP-1 Receptor Agonist Market Size & Outlook, 2033 (Horizon Databook), https://www.grandviewresearch.com/horizon/outlook/glp-1-receptor-agonist-market/asia-pacific
2. Grand View Research. (2026). South Korea GLP-1 Receptor Agonist Market Size & Outlook, 2033, https://www.grandviewresearch.com/horizon/outlook/glp-1-receptor-agonist-market/south-korea
3. Gan & Lee Pharmaceuticals Officially Initiates GRADUAL-3, China's First Phase III Clinical Trial for Weight Management with a Once-Monthly GLP-1RA. [Press Release], https://mp.weixin.qq.com/s/wHWm0CPGRfwTK6iTcjHwfA
4. From "Follower" to "Leader": Domestic Bi-weekly Bofanglutide Debuts at ADA, Ushering in "China Time" for Diabetes Treatment. [Press Release], https://mp.weixin.qq.com/s/6p_ou6d4DmopTennpKxbCg
5. Gan & Lee Pharmaceuticals' Bofanglutide (GZR18) Injection Approved for Clinical Trial of New Indication: Moderate to Severe Obstructive Sleep Apnea in Obese Adult Patients. [Press Release], https://mp.weixin.qq.com/s/AT_v7pctR5CxaX7BgHcN5A
6. Gan & Lee Pharmaceuticals Enters into an Exclusive Commercial Agreement with Renowned Latin American Pharmaceutical Company PC for Bofanglutide. [Press Release], https://mp.weixin.qq.com/s/lTMxrLIb6ppZ76O9o5pGMw
7. Gan & Lee Pharmaceuticals Enters into a Partnership with Leading Indian Pharmaceutical Company Lupin. [Press Release], https://mp.weixin.qq.com/s/w44yByJ68buuyXSxwItFhg

About Gan & Lee

Gan & Lee Pharmaceuticals is a high-tech biopharmaceutical company and the first in China to master industrial-scale manufacturing technologies for recombinant insulin analogs. The Company has established a comprehensive insulin research and development pipeline.

Currently, Gan & Lee offers six core insulin products, including five insulin analogs: insulin glargine injection (Basalin^®; EU brand name Ondibta^®), insulin lispro injection (Prandilin^®; EU brand name: Bysumlog^®), insulin aspart injection (Rapilin^®; EU brand name: Dazparda^®), premixed insulin lispro protamine suspension injection (25R) (Prandilin^®25), and insulin aspart 30 injection (Rapilin^®30); as well as one human insulin product, premixed human insulin protamine suspension injection (30R) (Similin^®30), together with related delivery devices. These products cover the long-acting, rapid-acting, and premixed insulins.

In China's second round of national volume-based procurement for insulin, Gan & Lee ranked first among selected companies by contracted volume for insulin analogs, further strengthening its domestic market position. In parallel, the Company continues to advance its international expansion. Insulin glargine injection has received marketing authorization from the European Commission (EC), while for insulin lispro injection and insulin aspart injection, it has received the positive opinion from CHMP of EMA. Gan & Lee is steadily progressing toward its goal of becoming a key global participant in the field of metabolic diseases.

Looking forward, Gan & Lee is committed to achieving comprehensive coverage across the diabetes treatment landscape and further enhancing its competitive position in this therapeutic area. The Company will also actively pursue the development of innovative chemical drugs and biologics, with a strategic focus on metabolic diseases, cardiovascular diseases, and other therapeutic areas.