Celltrion Inc., of Incheon, South Korea, gained MFDS clearance of Eydenzelt (CT-P42) as a biosimilar referencing Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 30. The news comes on the heels of the U.S. FDA approving the first Eylea interchangeable biosimilars on May 20.
Cambridge, Mass.-headquartered Flagship Pioneering Inc. opened its Asia-Pacific (APAC) headquarters in Singapore on June 1, BioWorldlearned from APAC chair and strategic adviser André Andonian in a May 30 interview.
Celltrion Inc., of Incheon, South Korea, gained MFDS clearance of Eydenzelt (CT-P42) as a biosimilar referencing Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 30. The news comes on the heels of the U.S. FDA approving the first Eylea interchangeable biosimilars on May 20.
South Korean med-tech companies Nunaps Co. Ltd. and Share & Service are the latest to clear domestic approvals for digital therapeutics as the government ramps up R&D funding for artificial intelligence-based medical technologies.
Crescom Co. Ltd., of Seongnam-si, Gyeonggi-do, gained domestic approval for its AI-powered software to grade knee osteoarthritis, dubbed MediAI-OA, while launching a new AI-mobile platform, Onzaram, to help manage child growth care.
South Korean biopharma Aribio Co. Ltd. signed a $770 million deal to sign off exclusive rights to its early Alzheimer’s disease drug, AR-1001 (mirodenafil), in China. The exclusive deal for marketing rights will total about ¥5.59 billion (US$770 million), which includes a non-refundable up-front payment of ₩120 billion (US$90 million) and potential milestone payments, along with royalties.
As investment in Asia biohubs continues into 2024, Merck KGaA’s Milliporesigma is the latest to drop more than €300 million (US$328 million) into a new bioprocessing production center in Daejeon, South Korea.
South Korean biopharma Aribio Co. Ltd. signed a $770 million deal to sign off exclusive rights to its early Alzheimer’s disease drug, AR-1001 (mirodenafil), in China. The exclusive deal for marketing rights will total about ¥5.59 billion (US$770 million), which includes a non-refundable up-front payment of ₩120 billion (US$90 million) and potential milestone payments, along with royalties.
As investment in Asia biohubs continues into 2024, Merck KGaA’s Milliporesigma is the latest to drop more than €300 million (US$328 million) into a new bioprocessing production center in Daejeon, South Korea. Other big pharmas, including Switzerland’s Novartis AG, Denmark’s Novo Nordisk A/S and China’s Wuxi Biologics (Cayman) Inc., are also making multimillion-dollar investments in the Asia-Pacific region, according to company announcements made in March 2024.
Seoul-based Genexine Inc. filed a BLA to gain domestic approval of its follow-on biologic for chronic kidney disease (CKD)-induced anemia, Efesa (efepoetin alfa, GX-E4), to South Korean health regulators on Jan. 25.
