Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration (nAMD), and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration.
A next-generation triple incretin therapy jointly developed by Novo Nordisk A/S and China’s United Biotechnology outperformed semaglutide in a phase II trial, signaling intensifying competition in the GLP-1 obesity and diabetes market.
Simcere Pharmaceutical Group Ltd.’s monoclonal antibody, rademikibart (CBP-201), met the primary endpoint in a Chinese phase III study in adults and adolescents with moderate to severe atopic dermatitis.
Braveheart Bio Inc. reported positive results from an open-label randomized phase II dose-ranging study of BHB-1893 (HRS-1893) in obstructive hypertrophic cardiomyopathy. Results presented at the American College of Cardiology’s Annual Scientific Session and Expo in New Orleans showed BHB-1893 treatment was associated with rapid and substantial reductions in left ventricular outflow tract gradient, the primary endpoint of the study.
Regulatory snapshots for biopharma and med tech in Asia-Pacific, including global submissions and approvals, and other regulatory decisions and designations: Deciphera, Eisai, GC, GSK, Immunitybio, Mars Bioimaging, Nuvation, Ono, OS Therapies, Pharming, Regeneron, Sanofi, Tarsus, Viatris.
Clinical updates for biopharma and med tech in Asia-Pacific, including data readouts and publications: Brightgene, Dizal, Harbour, Immunexpress, Innovent, Novo Nordisk, Otsuka, Prestige, Radiopharm, United Laboratories.
Excalipoint Therapeutics Inc. launched with an oversubscribed $68.7 million seed financing round to advance a portfolio of T-cell engagers for solid tumors, marking one of the largest early stage financings in China biotech history.
Imbiologics Corp.’s market capitalization reached ₩1.5 trillion (US$1.02 billion) on its Kosdaq debut March 20, as the biotech seeks to become a leading antibody drugmaker for autoimmune diseases.