Formosa Pharmaceuticals Pipeline
Kadcyla®Biosimilar｜TSY-0110
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 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
EirGenix
- 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 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%.
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.
