Formosa Pharmaceuticals, Inc. (TWSE: 6838), a Taiwan-based biopharmaceutical company, announced on Friday that it has submitted a Clinical Trial Application (CTA) to European regulatory authorities to conduct a pivotal clinical trial of TSY-110.
The product is a biosimilar candidate referencing Roche's antibody-drug conjugate Kadcyla (ado-trastuzumab emtansine), indicated for HER2-positive metastatic and early-stage breast cancer.
The upcoming trial is designed subsequent to regulatory guidance from both US and EU authorities, and will assess the safety, tolerability, pharmacokinetics, and immunogenicity profile of TSY-110 compared with the reference product.
CelLBxHealth secures USD65,000 pharmaceutical research contract
Racura Oncology receives approval for RC220 trial to proceed to higher dose
Blue Lake Biotechnology reports interim data from Phase 1/2a paediatric clinical trial of BLB201
Solvonis signs Portugal agreement to assess European expansion of Phase 3 alcohol addiction trial
ABL Texcell Diagnostics acquires IntegraGen assets to expand into precision oncology
Akeso reports first patient dosed in Phase III study of cadonilimab in colon cancer
Natera secures FDA Breakthrough Device designation for multi-cancer early detection assay
FDA approves Genentech's Tecentriq combination therapy for stage III colon cancer
Alpheus Medical starts new clinical trial of PoMA therapy in butterfly glioblastoma
Sophos IRB and ALCMI partner to support lung cancer research
Northwest Biotherapeutics and NHSBT collaborate to support production of DCVax-L
argenx reports positive Phase 2 results for FB102 in coeliac disease