TSY-110 is positioned to become the first biosimilar alternative to Roche's Kadcyla^® (ado-trastuzumab emtansine) in major regulated markets.

-- Formosa Pharmaceuticals, Inc. (TWSE: 6838), announced the submission of a Clinical Trial Application (CTA) to European regulatory authorities to conduct a pivotal clinical trial for TSY-110. TSY-110 is a biosimilar candidate referencing Roche's antibody-drug conjugate (ADC) Kadcyla^® (ado-trastuzumab emtansine), indicated for HER2-positive metastatic and early-stage breast cancer.

Designed following regulatory guidance from both US and EU authorities, the upcoming trial will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity profile of TSY-110 compared with the reference product. This milestone advances Formosa Pharmaceuticals' and EirGenix's shared goal of providing cost-effective biosimilar ADC treatments to patients across regulated global markets.

"Filing this CTA marks a significant achievement for Formosa Pharmaceuticals and underscores our strategic alliance with EirGenix," said Erick Co, Ph.D., President and Chief Executive Officer of Formosa Pharmaceuticals. "Antibody-drug conjugates have established themselves as mainstays in oncology, including HER2-positive breast cancer care, but patient access remains constrained by high treatment costs. Advancing TSY-110 into clinical evaluation is a momentous step toward fulfilling our goal of delivering world-class, accessible ADC options to oncologists and patients."