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BioWorld - Tuesday, February 10, 2026
Home » Topics » Regulatory » MOHW

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Cells and DNA helix

South Korea enacts world’s first regulation on synthetic biology

Jan. 13, 2026
By Marian (YoonJee) Chu
No Comments
South Korea will implement a new regulation on synthetic biology in April 2026, aiming to foster innovations across both biotechnology and biomanufacturing.
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Cells and DNA helix

South Korea enacts world’s first regulation on synthetic biology

Jan. 7, 2026
By Marian (YoonJee) Chu
No Comments
South Korea will implement a new regulation on synthetic biology in April 2026, aiming to foster innovations across both biotechnology and biomanufacturing.
Read More
Gold won currency symbol on black background

South Korea approves record budgets for health agencies in 2026

Jan. 6, 2026
By Marian (YoonJee) Chu
No Comments
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.
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South Korea flag on blurred background
The year in review

Top issues in South Korea’s biotechnology sector in 2025

Dec. 30, 2025
By Marian (YoonJee) Chu
No Comments
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.
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South Korea flag on blurred background
The year in review

Top issues in South Korea’s biotechnology sector in 2025

Dec. 29, 2025
By Marian (YoonJee) Chu
No Comments
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.
Read More
Crescom MediAI-BA

Crescom wins FDA clearance for bone analysis

Dec. 24, 2025
By Marian (YoonJee) Chu
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.
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IPO stock market ticker

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

Dec. 17, 2025
By Marian (YoonJee) Chu
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.
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Kim Woo-youn, CEO and cofounder, Hits
Drug design, drug delivery & technologies

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

Dec. 17, 2025
By Marian (YoonJee) Chu
No Comments
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.
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Kim Woo-youn, CEO and cofounder, Hits
Newco news

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

Dec. 16, 2025
By Marian (YoonJee) Chu
No Comments
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.
Read More

Vigencell’s cell therapy for lymphoma meets phase II endpoint

Dec. 2, 2025
By Marian (YoonJee) Chu
No Comments
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.
Read More
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