Company Product Description Indication Status Date
Astrazeneca plc, of London, and Daiichi Sankyo Co. Ltd., of Tokyo Enhertu (trastuzumab deruxtecan) HER2-directed antibody-drug conjugate Advanced non-small-cell lung cancer European Commission approved the drug 10/25/2023
Bioray Pharmaceutical Co. Ltd., of Shanghai BR-105 Monoclonal antibody targeting SIRPα Cancer U.S. FDA cleared the IND for a phase I study 10/25/2023
Biosyngen Pte Ltd., of Singapore BST-02 Adoptive immune cell therapy Liver cancer U.S. FDA approved IND 10/27/2023
Calliditas Therapeutics AB, of Stockholm, and Everest Medicines Ltd., of Shanghai Nefecon Oral, delayed release formulation of budesonide Primary immunoglobulin A nephropathy Pharmaceutical Administration Bureau of the Macau Special Administrative Region approved NDA in China 10/30/2023
Genexine Inc., of Seoul, South Korea, and PT Kalbe Farma Tbk, of Jakarta, Indonesia Efepoetin alfa Long-acting erythropoietin Chronic kidney disease induced anemia Indonesian Food and Drug Authority approved the drug 10/25/2023
Life Molecular Imaging GmbH, of Berlin, and Sinotau Pharmaceutical Group, of Beijing Neuraceq (florbetaben F-18 injection) Radiopharmaceutical imaging agent targeting β-amyloid Alzheimer’s disease National Medical Products Administration in China approved the imaging agent 10/25/2023
Samsung Bioepis Co. Ltd., of Incheon, Korea Byooviz (ranibizumab-nuna) Biosimilar product interchangeable with Lucentis (ranibizumab); anti-VEGF Wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization U.S. FDA approved the supplemental BLA 10/26/2023
Sumitomo Pharma Canada Inc., a unit of Sumitomo Pharma Co. Ltd., of Osaka, Japan Orgovyx (relugolix) Gonadotropin-releasing hormone receptor antagonist Advanced prostate cancer Health Canada approved the drug 10/25/2023

Notes

The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found.

For more information about individual companies and/or products, see Cortellis.