Formosa Pharmaceuticals Pipeline
Kadcyla®Biosimilar｜TSY-110
Overview｜TSY-110 Kadcyla® Biosimilar
Develop world-class biosimilar solutions for HER2 ADC therapy
TSY-110 is a biosimilar of antibody-drug conjugate, ado-trastuzumab emtansine (Kadcyla®), co-developed by Formosa Pharmaceuticals and EirGenix (Asset Code: EG12043).
Our strategic objective for the TSY-110 project is to become the first Kadcyla® biosimilar to successfully launch in the regulated markets like US and EU. By achieving this milestone, we aim to provide an equally effective, high-quality, and far more economical treatment option for patients battling HER2-positive breast cancer. Furthermore, TSY-110 will serve as a crucial alternative for health insurance providers globally, alleviating the economic burden of oncological care while expanding patient access.
TSY-110 is in IND-enabling stage, with clinical trials expected to initiate in 2026.
Formosa Pharmaceuticals is seeking interested parties for regional/global licensing or co-development.
Market Potential｜TSY-110 Kadcyla® Biosimilar
Kadcyla was the first HER2-targeted antibody-drug conjugate (ADC) to hit the market, launched by Roche in 2013. Its indications cover both early-stage and metastatic breast cancer, including:
- Metastatic Breast Cancer (mBC): For the treatment of HER2-positive patients who have previously received trastuzumab and a taxane, separately or in combination.
- Early Breast Cancer (EBC): As an adjuvant therapy for HER2-positive patients who have residual invasive disease after receiving neoadjuvant treatment based on taxanes and trastuzumab.
As a key member of Roche’s HER2 franchise, Kadcyla has maintained steady growth since its launch. In 2025, its global sales reached approximately $2.5 billion.
Development Status｜TSY-110 Kadcyla® Biosimilar
Combining the antibody and bioconjugation technology of a top biopharmaceutical company and a CDMO in Taiwan, TSY-110 has achieved excellent biosimilarity, as well as:
- Manufacturing Consistency
- Successful GMP scale-up
- Potency, Stability, and Plasma Kinetics similar to reference drug
Successful BPD Type II meeting with the US Food and Drug Administration (FDA) in 2026, confirming trial design and CMC strategy.
Manufacturing and Development Partners ｜TSY-110 Kadcyla® Biosimilar
To realize the immense potential of TSY-110, 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.
Licensing Opportunity ｜TSY-110 Kadcyla® Biosimilar
Formosa Pharmaceuticals is seeking interested parties for regional/global licensing or co-development.
About Her2-positive Breast Cancer Market:
In 2020, the cases of new HER2-positive breast cancer in the world annually reached nearly 197,000 cases. By 2030, the number is estimated to be nearly 230,000, for a growth rate of 16.7%.
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.
