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BioWorld - Monday, December 22, 2025
Home » Topics » Regulatory » MOHW

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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.
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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.
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Vigencell’s cell therapy for lymphoma meets phase II endpoint

Nov. 26, 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.
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Man measuring waist

Hanmi’s efpeglenatide hits phase III endpoints in obesity

Oct. 28, 2025
By Marian (YoonJee) Chu
No Comments

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.


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Kim Kyung-ah, CEO, Samsung Bioepis

South Korea to hike biosimilar approval fees, slash review times

Sep. 16, 2025
By Marian (YoonJee) Chu
No Comments
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.
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Kim Kyung-ah, CEO, Samsung Bioepis

South Korea to hike biosimilar approval fees, slash review times

Sep. 15, 2025
By Marian (YoonJee) Chu
No Comments
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.
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Spikevax vial and product packaging

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

Sep. 2, 2025
By Marian (YoonJee) Chu
No Comments
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.
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K-Organoid Consortium

South Korea forms new organoid consortium for nonanimal testing

Aug. 26, 2025
By Marian (YoonJee) Chu
No Comments
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.
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