Astellas Pharma Inc. reported Oct. 14 that its CLDN18.2-targeting monoclonal antibody, zolbetuximab (Vyloy), did not meet the primary endpoint of overall survival in the phase II Gleam trial of patients with advanced pancreatic cancer.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Celltrion, Cosmo, Neurizon.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Alterity, Carsgen, HEnlius, Hope, Ono, Ribomic.
Biopharma financings from January through September 2025 totaled $47.1 billion, a sharp decline from 2024’s $86.7 billion during the same period and well below the highs of 2020 and 2021. The slowdown was driven largely by weaker follow-on activity, which brought in $12.9 billion compared to more than $40 billion last year.
Taho Pharmaceuticals Ltd. announced an NDA submission to the U.S. FDA for TAH-3311, developed as the world’s first oral dissolving film formulation of apixaban, marking a regulatory milestone for the Taipei-based biotech.
Full-Life Technologies Ltd. announced Sept. 29 the completion of a $77 million financing, comprising $50 million in series C equity and $27 million in debt financing, which will be used to advance a portfolio of radiopharmaceuticals and radionuclide-drug conjugates worldwide.
Takeda Pharmaceutical Co. Ltd. is exiting all work in cell therapies and will seek an external partner to advance the company’s research and clinic-ready cell therapy programs, the company said, noting that it is not currently running any clinical trials using cell therapy technology.
Kyorin Pharmaceutical Co. Ltd. is licensing Hinge Bio Inc.’s multispecific antibody-based therapy HB-2198 in Japan for multiple autoimmune indications, starting with systemic lupus erythematosus.
Nanyang Biologics Pte. Ltd. has entered a $1.5 billion business combination agreement with RF Acquisition Corp II, a Nasdaq-listed special purpose acquisition company. Singapore-based Nanyang Biologics (NYB) is building a hybrid platform to revolutionize drug discovery by combining machine learning with natural compound libraries, and NYB claims it is developing one of the world’s largest AI-curated collections of bioactive compounds.