Yuhan Corp. posted record-breaking third-quarter results, with revenue reaching 598.8 billion won and operating profit totaling 54.5 billion won. This performance was driven by Leclaza, the first Korean cancer drug to receive FDA approval in August. Yuhan’s earnings included an 80 billion won royalty payment from Janssen, which licensed Leclaza. The company expects additional royalties from future U.S. sales.
Korea’s pharmaceutical and biotech sectors are intensifying their push for FDA approvals, encouraged by the possibility that a new Trump administration could once again ease regulations on new drug approvals. Industry leaders see this potential shift as an opportunity to establish pharmaceuticals as a key growth engine alongside Korea’s thriving semiconductor sector. To date, only nine Korean-made drugs have received FDA approval in the past 20 years, but many others are progressing through clinical trials.
TissueGene, for example, completed patient dosing for its Phase 3 U.S. clinical trial of TG-C, a gene therapy for knee osteoarthritis, in July. TG-C, which received regulatory approval in Korea in 2017 as the world’s first osteoarthritis gene therapy, encountered a temporary hold on its U.S. trials in 2019 due to an injection ingredient issue. Trials resumed in 2020, with over 1,000 patients treated at a cost of 200 billion won. With the osteoarthritis treatment market projected to hit $20.2 billion by 2032, TissueGene plans to apply for FDA approval by 2026, targeting a U.S. launch as early as 2028.
Meanwhile, HK inno.N is advancing Phase 3 trials for K-CAB, its drug for gastroesophageal reflux disease, in partnership with U.S.-based Sebela Pharmaceuticals. Known for its rapid efficacy and ease of use, K-CAB has generated over 650 billion won in cumulative prescriptions since its 2019 release. HK inno.N aims to complete the trials and submit for FDA approval by mid-2025.
HLB has also resubmitted its application for FDA approval of Rivoceranib, a liver cancer treatment, following an initial request for additional data. A decision is expected early next year. Other Korean companies, including Hanall Biopharma with its myasthenia gravis drug IMVT-1401 and AriBio with its Alzheimer’s treatment AR1001, are on track to conclude Phase 3 trials and seek FDA approval next year.
Since LG Chem’s antibiotic Factive became the first Korean drug approved by the FDA in 2003, Korea’s pharmaceutical sector has made steady progress, achieving FDA approvals every two to three years since the mid-2010s. Nonetheless, challenges remain, including limited FDA experience and funding constraints compared to global pharmaceutical giants. Many Korean firms continue to license drugs to international companies or form partnerships to complete the regulatory process. Industry experts argue that expanded government support for R&D, regulatory flexibility, and tax incentives are essential to enable Korean companies to thrive in the global market as co-development of new drugs becomes the international standard.
