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South Korea streamlines biosimilar review, clinical trials

Tue, 07 Apr 2026 12:00:00 -0400

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.

How to grow a startup in the AI era: MedTech Spotlight Korea 2026

Tue, 24 Mar 2026 12:00:00 -0400

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.

How to grow a startup in the AI era: MedTech Spotlight Korea 2026

Mon, 23 Mar 2026 12:00:00 -0400

Korean ARPA-H to invest ₩162B in nine projects in 2026

Tue, 10 Mar 2026 12:00:00 -0400

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.

Eli Lilly commits $500M to boost South Korea’s biomedical sector

Tue, 10 Mar 2026 12:00:00 -0400

Eli Lilly and Co. will invest $500 million to support South Korea’s biopharmaceutical industry over the next five years, following high-level talks March 9 between Prime Minister Kim Min-seok and Lilly Executive Vice President Patrik Jonsson.

Roche to invest ₩710B in South Korea over five years

Tue, 10 Mar 2026 12:00:00 -0400

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.

Eli Lilly commits $500M to boost South Korea’s biomedical sector

Mon, 09 Mar 2026 12:00:00 -0400

Korean ARPA-H to invest ₩162B in nine projects in 2026

Fri, 06 Mar 2026 12:00:00 -0500

Roche to invest ₩710B in South Korea over five years

Thu, 05 Mar 2026 12:00:00 -0500

South Korea enacts world’s first regulation on synthetic biology

Tue, 13 Jan 2026 00:00:00 -0500

South Korea will implement a new regulation on synthetic biology in April 2026, aiming to foster innovations across both biotechnology and biomanufacturing.

South Korea enacts world’s first regulation on synthetic biology

Wed, 07 Jan 2026 12:00:00 -0500

South Korea will implement a new regulation on synthetic biology in April 2026, aiming to foster innovations across both biotechnology and biomanufacturing.

South Korea approves record budgets for health agencies in 2026

Tue, 06 Jan 2026 12:00:00 -0500

South Korea’s National Assembly approved the largest budgets for its health ministries in 2026, including the Ministry of Health and Welfare, Ministry of Food and Drug Safety and Korea Disease Control and Prevention Agency.

Top issues in South Korea’s biotechnology sector in 2025

Tue, 30 Dec 2025 00:00:00 -0500

U.S. policy, China’s strategic rise, blockbuster deals and AI dominated South Korea’s biotechnology industry this year, with U.S. tariffs and the Biosecure Act’s hitch onto 2026 legislation serving as major topics of speculation.

Top issues in South Korea’s biotechnology sector in 2025

Mon, 29 Dec 2025 12:00:00 -0500

Crescom wins FDA clearance for bone analysis

Wed, 24 Dec 2025 11:00:00 -0500

Crescom Co. Ltd., an AI musculoskeletal imaging company, gained U.S. FDA 510(k) clearance Dec. 24 for MediAI-BA, its AI-powered pediatric and adolescent bone age analysis software. Classified as a class II medical device, MediAI-BA evaluates bone age and suggests predicted adult height based on growth plate status assessed by hand and wrist X-ray imaging. Prior clinical trial results demonstrated MediAI-BA had specialist-level accuracy, recording a mean absolute deviation (MAD) of 0.39 years.

Acryl raises $28M IPO, aiming to bridge medical divide with AI

Wed, 17 Dec 2025 11:00:00 -0500

Acryl Inc. debuted on South Korea’s Kosdaq Dec. 16, raising ₩42.12 billion ($28.5 million) in an IPO. Shares (KOSDAQ:0007C0) closed at ₩67,000 on the first day, up 243.5% from its offering price, before closing 30% down on Dec. 17 at ₩47,500. Seoul, South Korea-based Acryl sold 2.16 million shares priced at ₩19,500 each. Notably, Acryl won South Korea Ministry of Food and Drug Safety approval of Acryl-D01 software in December 2024, making it the country’s first AI-based digital therapeutic solution for depression screening and diagnosis. The generative AI-based medical software is cleared to analyze patient interviews and medical records and provide a probability score for clinical depression.

Hits’ Hyperlab launches as ‘virtual AI lab’ for new drug discovery

Wed, 17 Dec 2025 09:00:00 -0500

Things once done in laboratories can now be done with computers and AI, said Kim Woo-youn, CEO and cofounder of Hits Inc. “We live in the age of ‘digital alchemy,’” Kim told BioWorld, describing how AI is shifting some drug discovery processes from physical to virtual spaces.

Hits’ Hyperlab launches as ‘virtual AI lab’ for new drug discovery

Tue, 16 Dec 2025 12:00:00 -0500

Vigencell’s cell therapy for lymphoma meets phase II endpoint

Tue, 02 Dec 2025 00:00:00 -0500

Vigencell Inc. plans to seek conditional approval in South Korea for VT-EBV-N, an antigen-specific killer T-cell therapy for natural killer T-cell lymphoma, after gaining positive top-line data from a phase II study Nov. 25.

Vigencell’s cell therapy for lymphoma meets phase II endpoint

Wed, 26 Nov 2025 12:00:00 -0500

Hanmi’s efpeglenatide hits phase III endpoints in obesity

Tue, 28 Oct 2025 11:00:00 -0400

Hanmi Pharmaceutical Co. Ltd. announced Oct. 27 that its glucagon-like peptide-1 receptor agonist, efpeglenatide (HM-11260C), met the co-primary endpoints in a phase III study of obese adults without diabetes.

South Korea to hike biosimilar approval fees, slash review times

Tue, 16 Sep 2025 11:00:00 -0400

South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.

South Korea to hike biosimilar approval fees, slash review times

Mon, 15 Sep 2025 11:00:00 -0400

South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.

South Korea clears Moderna’s Spikevax LP.8.1 vaccine for COVID-19

Tue, 02 Sep 2025 11:00:00 -0400

South Korea’s Ministry of Food and Drug Safety approved Moderna Inc.’s Spikevax LP.8.1 vaccine as an updated shot for COVID-19 targeting the LP.8.1 variant, according to Moderna Korea’s announcement Sept. 1. The regulatory clearance comes days after the U.S. FDA accepted, on Aug. 27, Moderna’s supplemental BLAs for two of its COVID-19 vaccines, Spikevax and Mnexspike.

South Korea forms new organoid consortium for nonanimal testing

Tue, 26 Aug 2025 11:00:00 -0400

South Korea’s Ministry of Food and Drug Safety (MFDS) launched a new industry-academia-research consortium to support the nation’s organoid industry, expected to grow in light of the U.S. FDA’s shift away from animal testing in the development of novel drugs.

Aivis’ Qanti IHC uses AI to visualize biomarkers in cancer care

Mon, 25 Aug 2025 12:00:00 -0400

Lee Dae-hong founded Aivis Inc. in January 2021 as an AI-powered pathology software company, having led the development of the world’s first commercial under-display fingerprint recognition algorithm that was later incorporated into the Galaxy S10 and Galaxy A series of smartphones of Samsung Electronics Co. Ltd.

South Korea forms new organoid consortium for nonanimal testing

Thu, 21 Aug 2025 11:00:00 -0400

South Korea forms new organoid consortium for nonanimal testing

Thu, 21 Aug 2025 11:00:00 -0400

KDCA readies mRNA vaccines, tech for COVID-19, future outbreaks

Tue, 12 Aug 2025 11:00:00 -0400

Korea Disease Control and Prevention Agency (KDCA) secured 5.3 million doses of COVID-19 vaccines made by Pfizer Inc./Biontech SE and Moderna Inc., officially including the mRNA-based vaccines in the country’s national immunization program on Aug. 5.

South Korea hits record $23B pharma production; 2024 exports up 28%

Tue, 29 Jul 2025 11:00:00 -0400

South Korea’s pharmaceutical manufacturing reached an all-time high of ₩32.86 trillion (US$23 billion) in 2024, representing a 7.3% increase from 2023 and the highest on record since the country began count in 1998.