Ono Pharmaceutical Co. Ltd. struck a licensing deal with Ionis Pharmaceuticals Inc. for sapablursen, which is in phase II trials for polycythemia vera. Under terms, Osaka, Japan-based Ono gains an exclusive license to develop and commercialize sapablursen worldwide. Carlsbad, Calif.-based Ionis will be responsible for completing the ongoing phase II Imprssion study, while Ono will be responsible for subsequent development, regulatory filings and commercialization.
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).
Aim Vaccine Co. Ltd. may become the first company to gain regulatory clearance of a prophylactic iterative serum-free human rabies vaccine. Beijing-based Aim said it is preparing a regulatory submission of its independently developed rabies vaccine based on positive phase III results that showed good safety, immunogenicity and immune persistence.
The antibody-drug conjugate (ADC) juggernaut powers on, with Japan’s Taiho Pharmaceutical Co. set to acquire Araris Biotech AG for up to $1.14 billion. Of that, $400 million will be up front, with the remainder tied to milestones with a maximum value of $740 million, around the progress of three ADCs for treating solid and hematological cancers.
Artificial intelligence (AI) drug developer Insilico Medicine raised $110 million in a series E round led by an Asian private equity fund, Value Partners Group, that will see Insilico advance its pipeline and AI platform developments.
Visen Pharmaceuticals Co. Ltd. announced its initial public offering (IPO) on the Hong Kong Stock exchange (HKEX) to raise roughly HKD$603.3 million (US$77.6 million) to advance its pipeline of endocrinology assets.
Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.
Japanese-founded Regcell Inc. has raised $45.8 million and is redomiciling to the U.S. to accelerate clinical development of its pioneering regulatory T-cell (Treg) platform for autoimmune diseases and transplantation.
China’s National Medical Products Administration (NMPA) approved the country’s first injectable teprotumumab biosimilar from Innovent Biologics Inc. under the brand name of Sycume (teprotumumab N-01) to treat thyroid eye disease on March 14. The NMPA on March 15 accepted Simcere Pharmaceutical Group Ltd.’s NDA of deunoxavir marboxil (ADC-189) tablets, a product originally developed by Jiaxing Andicon Biotech Co. Ltd. to treat influenza A and B.
Alteogen Inc. signed its first billion-dollar partnership this year for ALT-B4 technology through two separate contracts with Astrazeneca plc’s U.K.- and U.S.-based Medimmune subsidiaries worth up to $1.35 billion combined.
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