#Taiwan #Taipei #Sandoz #EirGenix #EG1206A

EirGenix Forms Strategic Partnership for HER2 Biosimilar

EirGenix Inc., a Taiwanese biopharmaceutical company, made headlines on November 12, 2025, by announcing the signing of an exclusive global license agreement with Sandoz AG, a global leader in biosimilars. This partnership focuses on EirGenix’s HER2 biosimilar, EG1206A, which is aimed at treating HER2-positive breast cancer, a condition affecting a significant number of patients worldwide.

Details of the Agreement

The agreement specifically excludes territories such as Taiwan, mainland China, South Korea, and several others in the Asia-Pacific region. Under the terms, EirGenix is set to receive up to $152 million in upfront and milestone payments, in addition to earning royalties once the product hits the market. This collaboration not only enhances EirGenix's financial standing but also solidifies its commitment to the development of innovative biosimilar treatments.

EirGenix has already completed pharmacokinetic studies for EG1206A and has received favorable feedback from both the FDA and the European Medicines Agency (EMA) regarding a shortened development path that avoids lengthy Phase III comparative efficacy trials. This clearance can significantly expedite market access for the new biosimilar.

Background on Breast Cancer Treatment

The World Health Organization reports that approximately 2.3 million women are diagnosed with breast cancer each year, with nearly 20% of those cases being HER2-positive. The standard treatment currently involves a combination of Trastuzumab and Pertuzumab—a regimen that has proven effective but continues to evolve. Recent studies also suggest that the combination of Pertuzumab with Trastuzumab Deruxtecan (Enhertu) might represent a new frontline therapy for HER2-positive metastatic breast cancer, indicating a promising avenue for the potential of EG1206A in the market.

With the introduction of EG1206A, patients now have access to a new second-generation biosimilar option that complements EirGenix’s existing biosimilar EG12014 (a Trastuzumab biosimilar), which has already been approved in Europe and is undergoing a Biologics License Application (BLA) process with the FDA.

Strategic Implications

This collaborative effort further strengthens the established relationship between Sandoz and EirGenix. The two companies had previously teamed up for a marketing agreement on EG12014, symbolizing a growing alignment in their pursuit of providing affordable cancer therapies globally. Sandoz has long been recognized as a leader in the production of high-quality generic and biosimilar medications, emphasizing access and affordability for patients.

According to Roche's 2024 annual report, the global revenue for Perjeta, a key cancer treatment, reached CHF 3.62 billion (approximately USD 4 billion), highlighting the immense market potential for biosimilars like EG1206A.

Future Outlook

The agreement showcases EirGenix's innovative capabilities in reverse engineering to develop competitive biosimilars. As demand for affordable cancer therapies rises globally, EirGenix is accelerating the development of additional HER2-targeted antibody programs while enhancing its product pipeline and CDMO capabilities for further biosimilar projects.

The increasing utilization of EirGenix's commercial production lines demonstrates its commitment to scaling operations in response to global requirements. The company aims to become a significant development and production partner in the biosimilar landscape.

As the sector evolves rapidly, partnerships like that of EirGenix and Sandoz serve as vital components in the fight against cancer, pushing towards more sustainable healthcare solutions while improving patient access to critical treatments.