Hanmi Pharmaceutical Holds Corporate Briefing at Pyeongtaek Bio Plant Ahead of Launch of 'K-Obesity Drug'

Efiglenatide, Korea’s First GLP-1 Obesity Drug, Set for Launch in the Second Half of the Year

Hanmi Pharmaceutical announced on the 18th that it held a corporate briefing session (IR) at its Pyeongtaek Bio Plant on the 12th, inviting more than 20 domestic securities analysts.

The briefing session was attended by Shim Byunghwa, Vice President and Head of Growth Support at Hanmi Pharmaceutical, Kim Saegwon, Head of the Pyeongtaek Manufacturing Center (Executive Director), and Yang Junhyuk, Head of the RA Team at the New Product Development Center (Director). They directly introduced Hanmi's biopharmaceutical production capabilities and global supply system, and shared the current status of commercialization for major biopharmaceutical pipeline candidates.

Interior facilities of Hanmi Pharmaceutical's Pyeongtaek Bioplant. Hanmi Pharmaceutical

Shim Byunghwa, Vice President and Head of Growth Support at Hanmi Pharmaceutical, stated in his greeting, "It is meaningful to introduce Hanmi's differentiated manufacturing capabilities and technology base as we approach the launch of the innovative obesity treatment efiglenatide in the second half of the year." He added, "The Pyeongtaek Bio Plant is a core hub that connects Hanmi's R&D achievements to successful global commercialization, and serves as a strategic production base to drive the commercialization of next-generation new drugs that will be our future growth engine."

The analyst group began with an introduction to Hanmi Pharmaceutical’s overall business, followed by explanations of the Pyeongtaek Bio Plant's production facilities, quality systems, and global supply operation systems, then toured the manufacturing site. In particular, the visitors gave high marks to Hanmi's overall biopharmaceutical production processes, large-scale facility operation experience, and strategic operating direction for targeting global markets.

Wi Haejoo, a researcher at Korea Investment & Securities, commented, "The capabilities Hanmi Pharmaceutical has accumulated through collaboration with major global pharmaceutical companies are systematically reflected throughout its production facilities." He continued, "We confirmed Hanmi's manufacturing competitiveness in supporting the commercialization of efiglenatide in the second half of the year, including a quality system verified by the U.S. Food and Drug Administration (FDA) approval and regular inspections of Rolbedon, and a production capacity (CAPA) of up to 20 million doses annually."

Shim Byunghwa, Executive Vice President and Head of Growth Support Division at Hanmi Pharmaceutical, is giving a greeting at the domestic securities analysts' invitation company briefing (IR) held on the 12th of this month at the Pyeongtaek Bio Plant. Hanmi Pharmaceutical

The Pyeongtaek Bio Plant is an advanced facility capable of producing up to 20 million prefilled syringes annually for finished pharmaceutical products, and it is equipped with a cGMP-compliant manufacturing and quality system in accordance with U.S. FDA regulations.

Currently, the Pyeongtaek Bio Plant serves as the global supply and production center for Hanmi Pharmaceutical's key biopharmaceutical pipeline candidates, both in clinical and commercial stages. These include: ▲ Clinical trial supplies for a new MASH treatment candidate under development by a global partner; ▲ Rolontis (U.S. product name: Rolbedon), a treatment for neutropenia that is expanding its global reach; and ▲ Efiglenatide, Korea's first GLP-1-based treatment for obesity and metabolic diseases, scheduled for launch in the second half of this year.

Since its launch in the U.S. in 2022, Rolbedon has continued its annual growth trend, with cumulative sales nearing 300 billion won. Hanmi Pharmaceutical signed a supply agreement with its Middle Eastern partner Tabuk in September last year and plans to begin exporting finished products after obtaining local regulatory approval.

At the beginning of this year, Hanmi Pharmaceutical signed an exclusive distribution agreement for efiglenatide with its Mexican partner Sanfer and is pursuing local approval procedures based on Korean regulatory approval. The company is also considering expanding the global reach of these products to additional markets, including Latin America, the Middle East, and Southeast Asia.

Kim Saegwon, Head of the Pyeongtaek Manufacturing Center at Hanmi Pharmaceutical (Executive Director), said, "The Pyeongtaek Bio Plant is a production base equipped with large-scale advanced manufacturing facilities, specialized personnel, and systems, symbolizing Hanmi's integrated competitiveness that organically connects R&D and manufacturing." He added, "We will continue to advance our world-class production and quality systems to support the commercialization of innovative new drugs such as next-generation obesity and metabolic disease treatments, further strengthening our global competitiveness."

This content was produced with the assistance of AI translation services.