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BioWorld - Sunday, April 19, 2026
Breaking News: Best of BioWorld: Q1Breaking News: Best of BioWorld: Q1
Home » Topics » BioWorld Asia, Regulatory

BioWorld Asia, Regulatory
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Korea ARPA-H roundtable

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

March 10, 2026
By Marian (YoonJee) Chu
No Comments
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.
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Eli Lilly commits $500M to boost South Korea’s biomedical sector

March 10, 2026
By Marian (YoonJee) Chu
No Comments
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.
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MOHW Minister Jeong Eun Kyeong and Jörg-Michael Rupp, Roche

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

March 10, 2026
By Marian (YoonJee) Chu
No Comments
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.
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Taiwan President Lai Ching-te presides over the seventh meeting of the Healthy Taiwan Promotion Committee.

Taiwan to invest $752M in biopharma security over four years

March 10, 2026
By Marian (YoonJee) Chu
No Comments
Taiwan plans to invest NT$24 billion (US$752 million) over four years to bolster national biosecurity, expand domestic pharmaceutical production and safeguard against global supply chain volatility.
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US taking a closer look at China biotech subsidies

March 3, 2026
No Comments
U.S. scrutiny of China’s trade practices, especially in the biotech sector, continues to escalate as the U.S. International Trade Commission launches two factfinding investigations Congress mandated in the fiscal 2026 appropriations.
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Jiuyuan seeks approval of Wegovy biosimilar in China

March 3, 2026
By Marian (YoonJee) Chu
No Comments
China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.
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Stem cells

Japan endorses two iPSC drugs for approval under CEA pathway

Feb. 24, 2026
By Marian (YoonJee) Chu
No Comments
Japan is backing conditional approvals of Amchepry (raguneprocel, Sumitomo Pharma Co. Ltd./Racthera Co. Ltd.) and Reheart (Cuorips Inc.), positioning them to become the world’s first induced pluripotent stem cell-derived (iPSC) therapies to receive regulatory clearance.
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Takeda’s oral narcolepsy drug steps closer to FDA approval

Feb. 24, 2026
By Marian (YoonJee) Chu
No Comments

The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.


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Approved stamp
Biopharma approvals January 2026

China tops US in January drug approvals

Feb. 24, 2026
By Amanda Lanier
No Comments
U.S. FDA approvals began 2026 at a slower pace than usual, with eight approvals recorded in January.
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Gavel and block with Chinese flag

China amends drug rules to enforce lifecycle accountability

Feb. 10, 2026
By Tamra Sami
No Comments
China’s State Council updated its Drug Administration Law, and the changes mark a substantive evolution in the country’s drug regulatory framework.
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