SEOUL – Hanmi Pharmaceutical (KRX: 128940) announced on Wednesday that it has officially submitted a New Drug Application (NDA) to the Ministry of Food and Drug Safety (MFDS) for Efpeglenatide, its proprietary GLP-1 receptor agonist designed for the treatment of obesity and metabolic diseases.

The filing comes just 20 days after the drug was designated as a GIFT (Global Innovative Products on Fast Track) candidate by the MFDS. The GIFT program is designed to accelerate the review process for innovative medicines that demonstrate superior efficacy and safety, potentially shortening the timeline for commercialization.

Clinical Success and Performance

According to the company’s recent Phase 3 clinical trial results involving 448 obese adults, Efpeglenatide demonstrated a high level of efficacy. At the 40-week mark, top-line data revealed an average weight loss of 9.75%, with some participants experiencing a weight reduction of up to 30%. Furthermore, the drug showed a favorable safety profile compared to existing GLP-1 treatments, such as Wegovy (Semaglutide) and Zepbound (Tirzepatide), which are currently dominating the global market.

Unlike its competitors, which are often imported at high price points, Efpeglenatide is produced locally at Hanmi’s Pyeongtaek Bio Plant. This domestic production capability is expected to offer a significant price advantage, making chronic obesity management more accessible to the Korean public.

A Multi-Pronged "Life Cycle Management" Strategy

Hanmi Pharm is not positioning Efpeglenatide as a standalone product but as the centerpiece of a broader "Life Cycle Management" (LCM) strategy. This includes:

Indication Expansion: The company is currently conducting Phase 3 trials to combine Efpeglenatide with Metformin and SGLT-2 inhibitors to treat Type 2 diabetes.
Diverse Delivery Systems: To improve patient compliance, Hanmi plans to offer the drug in various formats, including auto-injectors, pre-filled syringes (PFS), and multi-pen devices.
Digital Integration: Hanmi aims to file an Investigational New Drug (IND) application in Q1 2024 for a "Digital-Convergence Medicine," which integrates the drug with digital medical devices to monitor patient progress in real-time.

Market Impact and Leadership

The domestic obesity treatment market is currently witnessing explosive growth. While global giants Novo Nordisk and Eli Lilly have faced supply chain hurdles, Hanmi's stable domestic supply chain could disrupt the current hierarchy.

"We are dedicating all our corporate resources to ensure the approval and launch of Efpeglenatide by 2026," said Kim Na-young, Head of Hanmi’s New Product Development Division. "This application is just the beginning of a new era for our metabolic pipeline."

Park Jae-hyun, CEO of Hanmi Pharmaceutical, added: "Through Efpeglenatide, we aim to go beyond simple weight loss. We are setting a new paradigm in metabolic treatment to substantially improve the quality of life for patients suffering from obesity-related complications."

Industry analysts suggest that if approved, Efpeglenatide could become the first Korean-made GLP-1 "blockbuster," potentially exported to global markets following its domestic debut.

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