SK Bioscience Co. Ltd. won €50 million (₩75.5 billion, US$52.03 million) up front from Sanofi SA to expand an earlier agreement to develop and commercialize novel pneumococcal conjugate vaccines (PCVs). The first deal resulted in GBP-410 (SP-0202), its pediatric 21-valent PCV candidate that moved into phase III study last week.
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.
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.
Caliway Biopharmaceuticals’ lipolysis candidate, CBL-514, met all the primary and secondary efficacy endpoints in a phase IIb study for subcutaneous fat reduction, paving the way for the company to begin a global pivotal phase III study in 2025.
Paradigm Biopharmaceuticals Ltd. raised AU$16 million (US$10.31 million) in a placement that will allow the company to start a global phase III trial with its lead product, Zilosul (injectable pentosan polysulfate/iPPS), to treat osteoarthritis.
Four Chinese biopharmaceuticals unveiled early data on respective cancer therapies at the American Society of Hematology (ASH) 2024 meet in San Diego, including Cstone Pharmaceuticals Co. Ltd.’s receptor tyrosine kinase-like orphan receptor 1 (ROR1)-inhibiting antibody-drug conjugate (ADC) in phase I study for lymphomas.
South Korean billionaire and chairman of Celltrion Group Jungjin Seo is returning Celltrion Inc. to its contract manufacturing organization (CMO) roots, as it relies on biosimilar sales to anchor the company in a fiercely competitive novel drug R&D arena.
After raising AU$40 million (US$25.9 million) earlier this year to advance lead candidate VP-001 for treating retinitis pigmentosa type 11, PYC Therapeutics is now advancing PYC-003 to the clinic for polycystic kidney disease.
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