JW Pharmaceutical has introduced a glucagon-like peptide-1 (GLP-1) class anti-obesity drug candidate that is administered once every two weeks from China's Gan & Lee Pharmaceuticals.
The company said on Apr. 9 that it signed an exclusive domestic licensing agreement with China's Gan & Lee Pharmaceuticals for the GLP-1 drug candidate "bofanglutide."
With this agreement, JW Pharmaceutical secured exclusive rights in Korea for the development, approval, marketing, and commercialization of bofanglutide. Gan & Lee will provide regulatory data required for investigational new drug (IND) approval and marketing authorization and support related procedures.
Gan & Lee Pharmaceuticals is a Beijing-based pharmaceutical company established in 1998 that developed China's first domestically made insulin analog.
The total value of the agreement is $81.10 million (120.1 billion won). JW Pharmaceutical will pay $5 million (7.4 billion won) upfront and up to $76.10 million (112.7 billion won) in milestone payments. The milestones include development, approval, and sales achievements for four indications: type 2 diabetes, obesity, obstructive sleep apnea (OSA), and metabolic dysfunction-associated steatohepatitis (MASH). Separate sales-based running royalties will also be paid.
Bofanglutide is a synthetic peptide being developed as a GLP-1 receptor agonist administered subcutaneously once every two weeks. Like Wegovy and Mounjaro, it acts on the GLP-1 receptor to promote insulin secretion and delay gastric emptying to maintain a feeling of fullness, aiming for both blood sugar control and weight loss. Wegovy and Mounjaro currently available in Korea are once-weekly injectables.
A phase 3 trial is underway in China. In a phase 2b trial in patients with obesity, biweekly dosing over 30 weeks produced an average weight loss of 17.29%. In the United States, a phase 2 trial is comparing placebo and tirzepatide, the active ingredient in Mounjaro, in patients who are overweight or have obesity.
JW Pharmaceutical views the extended dosing interval—"convenience"—as a differentiator in the GLP-1 therapy market, where once-weekly dosing is common. The strategy is to quickly enter the metabolic disease treatment market by introducing a candidate that has already progressed through a significant portion of clinical development.
The company has experience successfully establishing imported new drugs in the domestic market, such as the hyperlipidemia treatment "Livalo," the rheumatoid arthritis treatment "Actemra," and the hemophilia treatment "Hemlibra." This agreement is also seen as an extension of that licensing-in strategy.
JW Pharmaceutical plans to pursue a domestic phase 3 trial in the second half of this year for obesity and type 2 diabetes indications.