China's National Medical Products Administration (NMPA) approved Innovent Biologics Inc.’s NDA for Dovbleron (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for treating adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Accord, Celltrion, CSL Berhing, Everest, Eli Lilly, Innovent, Mesoblast, Merck.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Ena Respiratory, Immunabs, Immutep, Microbio.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Aadi, Certa, Corxel, Cytokinetics, Hangzhou Dac, Henlius, HLB Innovation, Inceptor, Lanova, Merck, Palleon, Racthera, Sumitomo Chemical, Verismo, Wuxi.
Kura Oncology, Inc. and Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor ziftomenib showed encouraging data across multiple studies, the most encouraging of which were in combination with other standard of care therapies in patients with NPM1-mutant and KMT2A-rearranged acute myeloid leukemia.
SK Bioscience Co. Ltd. gained approval from the Human Research Ethics Committee in Australia to start phase I/II trials of GBP-560, its mRNA-based vaccine candidate for mosquito-borne Japanese encephalitis virus, with funding from Coalition for Epidemic Preparedness Innovations.
Recce Pharmaceuticals Ltd. is progressing synthetic antibiotic Recce-327 to pivotal phase III trials in Indonesia for the treatment of diabetic foot infections. The trial, which is assessing Recce-327 as a topical gel (R327G), is expected to begin in the first quarter of 2025, Recce CEO James Graham told BioWorld.
Newron Pharmaceuticals SpA scored €44 million (US$46.26 million) up front in a potential €117 million licensing deal with EA Pharma Co. Ltd. to pad the clinical runway of its late-stage oral schizophrenia asset, evenamide (NW-3509), sending company stock prices up near 20%.
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