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BioWorld - Wednesday, January 7, 2026
Breaking News: BioWorld 2025 Year in ReviewBreaking News: BioWorld MedTech 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sector
Home » Topics » BioWorld Asia, Regulatory

BioWorld Asia, Regulatory
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Scinopharm wins US FDA approval of multiple sclerosis drug

Jan. 6, 2026
By Marian (YoonJee) Chu
No Comments
Scinopharm Taiwan Ltd. received U.S. FDA approval for its generic version of glatiramer acetate injection, a treatment for multiple sclerosis.
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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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Globe isolated on white background with focus on Asia and Australia
The year in review

Investment pays off as Asia shapes global biotech trends in 2025

Dec. 30, 2025
By Tamra Sami
No Comments
Asia, led by China, is no longer just following global pharma trends. It is helping to shape them, and for investors, innovators and policymakers, the question is no longer whether to engage with Asia, but how to engage wisely in this new, more complex world.
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Liver illustration

China accepts Hutchmed fanregratinib NDA on single phase II trial

Dec. 30, 2025
By Tamra Sami
No Comments
Hutchmed (China) Ltd. has moved closer to establishing China’s first domestically developed FGFR-targeted therapy for intrahepatic cholangiocarcinoma, after the National Medical Products Administration (NMPA) accepted its NDA for fanregratinib (HMPL-453) and granted the drug priority review.
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Illustration of intestinal track

China approves Innovent’s ipilimumab for colon cancer

Dec. 30, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration approved Innovent Biologics Inc.’s NDA for Tabosun (ipilimumab N01, IBI-310) in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high or mismatch repair deficient colon cancer.
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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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Illustration of knee joint, giant cell tumor of bone

China approves Abbisko/Merck’s CSF-1R inhibitor pimicotinib

Dec. 23, 2025
By Tamra Sami
No Comments
Abbisko Therapeutics Co. Ltd. and its partner Merck KGaA got an early Christmas present from China’s National Medical Products Administration (NMPA) with the approval of pimicotinib (ABSK-021), the first domestically developed systemic therapy for tenosynovial giant cell tumor (TGCT).
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US Biosecure Act a vote away from law

Dec. 16, 2025
By Mari Serebrov
No Comments
“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.
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China in red on globe

China introduces new reimbursement list for innovative drugs

Dec. 16, 2025
By Tamra Sami
No Comments
China unveiled its first Commercial Health Insurance Innovative Drug List (CIIDL), reimbursing 19 high-value innovative drugs, including all five domestically developed CAR T therapies as well as treatments for rare diseases and Alzheimer's disease.
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China approves Innovent’s picankibart as first domestic IL-23p19

Dec. 2, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration gave the nod to Innovent Biologics Inc.’s picankibart (IBI-112), branded as Pecondle, for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
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