Formosa Pharmaceuticals Pipeline
Enhertu® Biosimilar｜TSY-120
Develop world-class biosimilar solutions for HER2 ADC therapy
Overview｜TSY-120 Enhertu® Biosimilar
TSY-120 is a biosimilar program of the groundbreaking Antibody-Drug Conjugate (ADC) Enhertu® (trastuzumab deruxtecan), co-developed by Formosa Pharmaceuticals and EirGenix (Asset Code: EG12170). Our strategic objective for the TSY-120 project is to become the first Enhertu® biosimilar to successfully launch on the market. By achieving this milestone, we aim to provide an equally effective, high-quality, and far more economical treatment option for patients battling HER2-positive and HER2-low breast cancers. Furthermore, TSY-120 will serve as a crucial alternative for health insurance providers globally, alleviating the economic burden of oncological care while expanding patient access.
Market Potential｜TSY-120 Enhertu®Biosimilar
Enhertu® is a revolutionary ADC medicine designed to target HER2-positive breast cancer, HER2-Low breast cancer, and several other challenging malignancies, demonstrating outstanding efficacy over standard therapies. Its clinical success has led to approvals for over 10 indications globally, with ongoing clinical trials exploring its efficacy in treating triple-negative breast cancer (TNBC), osteosarcoma, and other solid tumors.
- Global sales of Enhertu® reached approximately $5 billion USD in 2025 and are projected to exceed a staggering $13 billion USD by 2032.
- Driven by these immense market opportunities, TSY-120 leverages the development experience from our earlier TSY-110 project to cultivate a distinct first-mover advantage in the global ADC biosimilar race.
Manufacturing and Development Partners ｜TSY-120 Enhertu® Biosimilar
To realize the immense potential of TSY-120, Formosa Pharmaceuticals and EirGenix have established a formidable alliance, further strengthened by capitalizing on the industry-leading ADC manufacturing capabilities of Formosa Laboratories. This powerful synergy creates a comprehensive, one-stop solution for ADC research, development, and manufacturing entirely within Taiwan, ensuring a highly stable supply chain.
Addressing Unmet Needs in Breast Cancer | HER2 Low Breast Cancer
The global incidence of HER2-positive breast cancer continues to rise, projected to grow to 230,000 annual cases by 2030.
Furthermore, improved testing methodologies have introduced a pivotal new classification: “HER2-low Breast Cancer”. Strikingly, approximately 55% of patients previously categorized as having HER2-negative breast cancer actually belong to this new category. Research has proven that these cancer cells can effectively act as receptors for novel ADC therapies.
For these patients, treatments like Enhertu® significantly prolong both Progression-Free Survival (PFS) and Overall Survival (OS) compared to traditional chemotherapy, representing a monumental advancement in care.
The Landscape of HER2+ ADC Drugs
HER2-positive targeting remains one of the most successful therapeutic targets in the ADC landscape, predominantly defined by Roche’s Kadcyla® and AstraZeneca/Daiichi Sankyo’s Enhertu®. These medications represent the absolute pinnacle of commercial success for ADC drugs.
The continued success of launched HER2+ ADC therapies points to a robust market. According to GlobalData, by 2031, the global market size for these two leading drugs alone is expected to reach an impressive $13.3 billion USD.
