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.
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.
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.
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.
South Korea will implement a new regulation on synthetic biology in April 2026, aiming to foster innovations across both biotechnology and biomanufacturing.
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.
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.
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.
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.