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BioWorld - Friday, April 17, 2026
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Home » Topics » BioWorld Asia, Regulatory

BioWorld Asia, Regulatory
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Kim Dong-gun (DG), CEO, Elevar

Elevar gets new CEO, files NDAs for lirafugratinib, rivoceranib

Feb. 3, 2026
By Marian (YoonJee) Chu
No Comments
Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.
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China NMPA approves Sciwind’s GLP-1 injection for diabetes

Feb. 3, 2026
By Marian (YoonJee) Chu
No Comments
Sciwind Biosciences Co. Ltd. said Jan. 30 it won Chinese approval for self-developed glucagon-like peptide-1 (GLP-1) receptor agonist, ecnoglutide (Xianyida), to treat adults with type 2 diabetes.
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Pill with Japanese flag

Why many global drugs never reach Japan

Feb. 3, 2026
By Tamra Sami
No Comments
For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.
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China accepts Telix/Grand Pharma NDA for TLX-591-CDx

Jan. 20, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has accepted for review Grand Pharmaceutical Group Ltd./Telix Pharmaceuticals Ltd.’s NDA for TLX-591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate for diagnosing prostate cancer.
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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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Hutchmed plans China NDA filing of sovleplenib in rare anemia

Jan. 13, 2026
By Marian (YoonJee) Chu
No Comments
Hutchmed Ltd. plans to file a second NDA in China for sovleplenib, a novel spleen tyrosine kinase inhibitor, based on positive phase II/III findings in warm antibody autoimmune hemolytic anemia.
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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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