JW Pharmaceutical 向韩国食药部申请 bofanglutide 2 型糖尿病 III 期临床，双周给药 GLP-1 推进肥胖/糖尿病双适应症并行

JW Pharmaceutical (001060) has applied for approval of a Phase 3 clinical trial in type 2 diabetes for bofanglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist candidate given once every two weeks. The filing follows an earlier Phase 3 application for the same drug as an obesity treatment, putting late-stage development of both indications on parallel tracks.
JW Pharmaceutical said on the 28th that it had submitted an investigational new drug (IND) application for the type 2 diabetes indication to the Ministry of Food and Drug Safety. The trial will enroll 174 patients in South Korea whose blood sugar remained inadequately controlled despite combined treatment with metformin and a sodium-glucose cotransporter-2 (SGLT-2) inhibitor. Starting in January, the study will compare the efficacy and safety of bofanglutide added to existing therapy against placebo through February 2029.
Bofanglutide is a GLP-1 receptor agonist for which JW Pharmaceutical secured exclusive development and commercialization rights in South Korea from China's Gan & Lee Pharmaceuticals in April. Unlike existing weekly GLP-1 treatments, it is being developed as a subcutaneous injection administered once every two weeks. If commercialized, it would reduce annual injections for obesity and diabetes patients to 26 from 52.
The company previously filed a Phase 3 IND application to evaluate the weight-loss efficacy and safety of bofanglutide in 300 adults with obesity or excess weight. That trial is scheduled to begin in December and conclude in March 2029. If both studies proceed as planned, Phase 3 results for the obesity and diabetes indications are expected in succession in the first half of 2029.
"We will conduct the trials without setbacks in order to strengthen our metabolic disease pipeline spanning obesity and diabetes, and to offer patients a new treatment option with greater dosing convenience," a JW Pharmaceutical official said.