South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
Orum Therapeutics Inc. on April 26 pulled the plug on a U.S.-based phase I study of ORM-5029, its lead oncology degrader antibody conjugate (DAC) asset, a decision that came months after the company first reported a patient death in November 2024.
ABL Bio Inc. announced April 7 that it sealed a potential £2.075 billion (US$2.65 billion) license deal with GSK plc, granting GSK global rights to use ABL’s blood-brain barrier (BBB) penetrating bispecific antibody platform, Grabody-B, to develop multiple programs in the neurodegenerative disease arena. Under the terms signed April 5, ABL agreed to transfer Grabody-B-related technology and know-how to GSK, upon which GSK will assume responsibility for preclinical and clinical development, manufacturing and commercialization.
South Korea’s Ministry of Food and Drug Safety on April 8 cleared Barythrax injection (GC-1109) as the world’s first recombinant anthrax vaccine. The product was codeveloped by GC Biopharma Corp. and Korea Disease Control and Prevention Agency.
ABL Bio Inc. announced April 7 that it sealed a potential £2.075 billion (US$2.65 billion) license deal with GSK plc, granting GSK global rights to use ABL’s blood-brain barrier (BBB) penetrating bispecific antibody platform, Grabody-B, to develop multiple programs in the neurodegenerative disease arena. Under the terms signed April 5, ABL agreed to transfer Grabody-B-related technology and know-how to GSK, upon which GSK will assume responsibility for preclinical and clinical development, manufacturing and commercialization.
The U.S. FDA rejected, for the second time, Elevar Therapeutics Inc.’s NDA of a novel combination therapy for advanced liver cancer, which comprised Jiangsu Hengrui Pharmaceutical Co. Ltd.’s PD-1 inhibitor camrelizumab and HLB Co. Ltd.’s small-molecule tyrosine kinase inhibitor, rivoceranib.
Nature Cell Co. Ltd. won U.S. FDA breakthrough therapy designation of its autologous adipose-derived mesenchymal stem cell therapy, Jointstem, March 20, becoming the first Korean company to earn the label in the field of cell therapy.
The U.S. FDA rejected, for the second time, Elevar Therapeutics Inc.’s NDA of a novel combination therapy for advanced liver cancer, which comprised Jiangsu Hengrui Pharmaceutical Co. Ltd.’s PD-1 inhibitor camrelizumab and HLB Co. Ltd.’s small-molecule tyrosine kinase inhibitor, rivoceranib.
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
