Hanmi Pharmaceutical said on the 18th that it held an investor relations (IR) session at the Pyeongtaek bio plant, the production base for Efpeglenatide, an obesity and metabolic disease treatment slated for launch in the second half of this year.
About 20 domestic securities firm analysts visited the Pyeongtaek bio plant, received briefings on production facilities, quality control systems, and the operating framework for global supply, and then toured the manufacturing site.
Hanmi Pharmaceutical said the Pyeongtaek bio plant has a current good manufacturing practice (cGMP) system that meets U.S. Food and Drug Administration (FDA) standards and can produce up to 20 million prefilled syringes a year for finished drugs.
Analysts who visited the site focused on production capacity and the quality system.
Wi Hae-joo, a researcher at Korea Investment & Securities Co., said, "The capabilities accumulated through collaboration with global pharmaceutical companies are reflected across the production facilities," adding, "We were able to confirm the quality system validated by FDA approval of Rolbedon and routine inspections, as well as production capacity reaching 20 million doses a year."
The Pyeongtaek bio plant is currently Hanmi Pharmaceutical's key biopharmaceutical production base. Representative products include clinical trial supplies for a candidate treatment for metabolic dysfunction-associated steatohepatitis (MASH) being developed by a global partner, the neutropenia treatment Rolontis (U.S. product name Rolbedon), and Efpeglenatide.
Since its U.S. launch in 2022, Rolbedon has continued to sell, and Hanmi Pharmaceutical last year signed a supply contract with Middle Eastern drugmaker Tabuk and plans to push for exports of finished goods after local approval. Efpeglenatide signed an exclusive distribution agreement with Mexican drugmaker Sanfer early this year and is undergoing the local approval process.
Kim Se-kwon, head of the Pyeongtaek manufacturing center, said, "The Pyeongtaek bio plant is a production base that demonstrates Hanmi's integrated competitiveness, with research and development and production organically linked," adding, "We will continue to advance our production and quality systems to support the commercialization of innovative new drugs, including next-generation obesity and metabolic disease treatments."