Hanmi Pharmaceutical announced on the 17th that it has completed the domestic approval application for "Efeglenatide Auto Injector" (HM11260C), a glucagon-like peptide-1 (GLP-1) class treatment for obesity and metabolic diseases independently developed by the company.
Hanmi Pharmaceutical completed the approval application to the Ministry of Food and Drug Safety just 20 days after Efeglenatide was designated as a target for the Global Innovative Products Fast Track (GIFT) program operated by the Ministry on November 27.
The GIFT program is a system that provides shortened review periods and customized review benefits for innovative new drugs that improve therapeutic efficacy and safety.
According to Hanmi Pharmaceutical, in the interim topline (primary endpoint) results of a 40-week phase 3 clinical trial conducted in October with 448 obese adults, Efeglenatide demonstrated up to 30% weight loss, an average weight loss rate of 9.75%, and favorable safety compared to existing GLP-1 agents.
Alongside the approval application, Hanmi Pharmaceutical announced plans to implement a "lifecycle management" (LCM) strategy for Efeglenatide, including expanding indications to diabetes, developing digital combination medicines, and launching customized health functional food packages as part of its value-up strategy.
Hanmi Pharmaceutical is working to expand indications to diabetes treatment through phase 3 clinical trials combining SG[255220]LT-2 inhibitor and metformin. The company also plans to enhance dosing convenience and medication adherence with formulations such as pre-filled syringes (PFS) and multi-pens, while also securing price competitiveness.
The digital combination medicine integrating Efeglenatide with a digital medical device aims to submit an Investigational New Drug (IND) application in the first quarter of next year. Kim Nayoung, Head of New Product Development at Hanmi Pharmaceutical, stated, "With the goal of launching next year, we will make company-wide efforts to secure approval for Efeglenatide," emphasizing that "this approval application marks another beginning."
Park Jaehyun, CEO of Hanmi Pharmaceutical, said, "Through the launch of Efeglenatide, Hanmi Pharmaceutical aims to open a new horizon in the field of obesity and metabolic disease treatment, going beyond simple weight loss to present a therapeutic paradigm that truly improves patients' quality of life."
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