South Korea’s Ministry of Food and Drug Safety (MFDS) approved Curocell Inc.’s Rimqarto (anbalcabtagene-autoleucel; anbal-cel) April 29 as the first homegrown CAR T-cell therapy to treat patients with advanced diffuse large B-cell lymphomas.
South Korea is rolling out regulatory changes to speed biosimilar development, including reforms to shorten review timelines, ease phase III trial requirements and simplify oversight of manufacturing changes.
AI and advanced biotechnology are reshaping South Korea’s med-tech sector, but great technology alone is not enough to build a successful medical device company, speakers said at MedTech Innovator’s Medtech Spotlight: New Impact Korea 2026.
AI and advanced biotechnology are reshaping South Korea’s med-tech sector, but great technology alone is not enough to build a successful medical device company, speakers said at MedTech Innovator’s Medtech Spotlight: New Impact Korea 2026.
Two biotech and three med-tech companies are slated for Kosdaq debuts this month, signaling a potential rebound for Korea financings in 2026. Kanaph Therapeutics Inc. will open with a ₩40 billion (US$26.99 million) raise and Imbiologics Corp. will debut with ₩52 billion. Additionally, Mezoo Co. Ltd., Cosmo Robotics Co. Ltd. and Recensmedical Inc. will launch IPOs.
Two biotech and three med-tech companies are slated for Kosdaq debuts this month, signaling a potential rebound for Korea financings in 2026. Kanaph Therapeutics Inc. will open with a ₩40 billion (US$26.99 million) raise and Imbiologics Corp. will debut with ₩52 billion. Additionally, Mezoo Co. Ltd., Cosmo Robotics Co. Ltd. and Recensmedical Inc. will launch IPOs.
The K-health MIRAE Initiative, also known as Korean ARPA-H, announced plans to allocate about ₩162 billion (US$110 million) in nine new projects over the next five years, with a focus on strengthening national health security.
Roche Holding AG pledged to invest ₩710 billion (US$484.6 million) in South Korea over the next five years, positioning the country as a major global hub for clinical trials. The near $500 million agreement inked with the Korean government will bring Roche’s clinical trials for common or incurable diseases and innovative biopharmaceutical products to the country.
