Formosa Pharmaceuticals Pipeline


TSY-0110 aims to be the first-launched biosimilar of Kadcyla, providing HER2+ positive breast cancer patients and insurance providers with an equally effective and more economical option for treatment .

Overview|TSY-0110 Kadcyla® Biosimilar

TSY-0110 Breast Cancer ADC

TSY-0110 is a biosimilar of antibody-drug conjugate, ado-trastuzumab emtansine (Kadcyla®)

TSY-0110 is in late-preclinical development stages, planning for CTA filing in 2024. Formosa Pharmaceuticals is seeking interested parties for regional/global licensing or co-development.

Development Status|TSY-0110 Kadcyla® Biosimilar

Combining the antibody and bioconjugation technology of two top CDMOs in Taiwan, TSY-0110 has achieved excellent biosimilarity, as well as:

  • Manufacturing Consistency
  • Successful GMP scale-up
  • Potency, Stability, and Plasma Kinetics similar to reference drug
  • Scientific Advice Meeting with European Medicines Agency (EMA)
  • BPD Type II meeting with the US Food and Drug Administration (FDA)

Manufacturing and Development Partners |TSY-0110 Kadcyla® Biosimilar


  • Antibody development and manufacturing EG12014
  • EG12014 has received marketing authorization from the European Commission (EC) and Taiwan FDA.

Formosa Pharmaceuticals

  • Develop and manufacture TSY-0110 by designating Formosa Laboratories as CMO.
    • GMP-approved CMC manufacturing for high-potent APIs
    • Bioconjugation of antibody and payload
    • Injectable and pre-filled syringe fill-finish production

Competitive Advantage |TSY-0110 Kadcyla® Biosimilar

  • Synergies in manufacturing and quality systems

  • Turnkey solution to ADC manufacturing

  • Strong and stable supply chain and scalability

Licensing Opportunity |TSY-0110 Kadcyla® Biosimilar

Formosa Pharma BD Licensing

Formosa Pharmaceuticals is seeking interested parties for regional/global licensing or co-development.

We expect to initiate Phase 3 clinical trials after the commercialization partner joins, and the clinical program can be carried out in accordance with the partners’ marketing goals and strategies.

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%.

When trastuzumab biosimilars and other generic drugs enter the market, the HER2-positive segment is still predicted to maintain a growth of 16%, of which China will grow by 72%, the US market will grow by 15.2%, and the EU-5 countries will grow by 3.6%.

HER2 Market Trend

About Kadcyla®

Kadcyla® is an Antibody-Drug Conjugate approved for second-line treatment for metastatic breast cancer (2013) and early Breast Cancer (2019).

Roche continues to strengthen Kadcyla’s market position through development of a variety of combination or adjuvant therapies.

Development Pipeline

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