Marking the second global approval after Japan, the U.S. FDA has approved Datroway (datopotamab deruxtecan), a trophoblast cell surface antigen 2-directed antibody-drug conjugate (ADC) from Daiichi Sankyo Co. Ltd. and Astrazeneca plc, for treating adults with hormone receptor-positive, HER2-negative unresectable or recurrent breast cancer after prior chemotherapy.
Shionogi & Co. Ltd. won a $375 million project agreement from the Rapid Response Partnership Vehicle to develop its 3CL protease inhibitor, S-892216, as a long-acting injectable for COVID-19 pre-exposure prophylaxis.
As more Asia biotechs turn to regenerative medicine to address disorders without a cure, Medipost Inc. is continuing global expansion with Cartistem, its allogeneic human umbilical cord blood-derived mesenchymal stem cell product that gained clearance in South Korea in 2012 to treat knee osteoarthritis.
In a deal potentially worth $810 million for Regenxbio Inc., Nippon Shinyaku Co. Ltd. is partnering on the U.S. and Asian development and commercialization of iduronate-2-sulfatase enzyme RGX-121 for Hunter syndrome and RGX-111 for Hurler syndrome.
The wheels of the antibody-drug conjugate (ADC) juggernaut keep on turning, with Araris Biotech AG announcing a deal with a headline value of $780 million to apply its multi-payload linker technology to generate novel ADCs for Chugai Pharmaceutical Co. Ltd.
Dimerix Ltd. and Fuso Pharmaceutical Industries Ltd. signed a license agreement for the development and commercialization of Dimerix’s phase III candidate, DMX-200, for the treatment of focal segmental glomerulosclerosis in Japan for ¥10.5 billion (US$66.5 million) plus royalties.
Kaken Pharmaceutical Co. Ltd.’s license agreement with Johnson & Johnson (J&J) for signal transducer and activator of transcription (STAT)6 inhibitor KP-723 could presage further deals in STAT6, where a number of developers are active. Kaken’s arrangement with J&J involves the global development, manufacturing and sale of KP-723, which has reached the preclinical stage. Tokyo-based Kaken will take the drug through phase I trials, after which J&J takes over.
Kaken Pharmaceutical Co. Ltd.’s license agreement with Johnson & Johnson (J&J) for signal transducer and activator of transcription (STAT)6 inhibitor KP-723 could presage further deals in STAT6, where a number of developers are active. Kaken’s arrangement with J&J involves the global development, manufacturing and sale of KP-723, which has reached the preclinical stage. Tokyo-based Kaken will take the drug through phase I trials, after which J&J takes over.
At Bio Japan 2024, policymakers and industry leaders pledged to make Japan a land of drug discovery to attract native and foreign drug developers. Like many Asian countries, Japan is harnessing and prioritizing the bio sector to drive economic growth, throwing its weight behind its 10-year Bioeconomy initiative to create bioclusters and increase investment.
Kaken Pharmaceutical Co. Ltd.’s license agreement with Johnson & Johnson (J&J) for signal transducer and activator of transcription (STAT)6 inhibitor KP-723 could presage further deals in STAT6, where a number of developers are active. Kaken’s arrangement with J&J involves the global development, manufacturing and sale of KP-723, which has reached the preclinical stage. Tokyo-based Kaken will take the drug through phase I trials, after which J&J takes over.
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