Hanmi Pharmaceutical has officially launched a companywide council aiming to secure market approval within the year for its glucagon-like peptide-1 (GLP-1) class obesity drug, Efpeglenatide (Efe).
Hanmi Pharmaceutical said on the 17th that it held a kickoff ceremony for "EFPE-PROJECT (Efe Project)-Seosa (narrative)" on the 13th at Hanmi C&C Square in Songpa-gu, Seoul. The companywide council launched that day to commercialize Efe will align development, clinical, marketing, manufacturing, distribution, and communications strategies into a single execution system.
Vice Chair Im Juhyun, CEO Hwang Sang-yeon, and other key executives attended the event. Heads of each division, including Kim Nayoung, head of new product development, Park Myeong-hee, head of domestic marketing, and Choi In-young, head of the R&D center, directly presented their strategies. Hanmi Pharmaceutical plans to review commercialization readiness through regular monthly meetings going forward.
CEO Hwang Sang-yeon said, "We are currently entering the final stage of development," and added, "We will maximize outcomes through meticulous preparation on the business side."
Reflecting "narrative" in the council's name stems from the view that Efe's development process aligns with the company's core values. After a major technology out-licensing in 2015, Efe went through twists and turns, including a contract being returned due to partner circumstances, and its development direction later shifted to an obesity treatment.
Vice Chair Im Juhyun said, "Efe is a project that has experienced both success and setbacks," adding, "It became an important turning point in the process of reestablishing the company's identity." Im added, "We will create new outcomes through commercialization."
On the development strategy side, the company will focus on the obesity indication while simultaneously pursuing expansion into diabetes. It also plans to strengthen product competitiveness by conducting research based on real-world data (RWD) and integrating digital technologies.
Marketing will adopt a strategy combining "convenience and premium." Rather than simple price competition, the plan is to approach the market based on perceived value such as clinical effectiveness and ease of use.
Efe is a long-acting GLP-1 receptor agonist that applies Hanmi Pharmaceutical's drug-sustaining technology, LAPSCOVERY. Its characteristics of gradual absorption and gentle maintenance of blood concentrations can reduce gastrointestinal side effects and the burden of dose escalation.
In a phase 3 cardiovascular outcomes trial (CVOT), the drug demonstrated a reduction in the risk of major adverse cardiovascular events (3-point MACE). The company said it has secured competitiveness in cardiovascular and kidney disease protection based on these results.