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On September 24, EirGenix (6589) announced that it has received positive feedback from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) during scientific consultations regarding the waiver of Phase III clinical trials for its breast cancer biosimilar candidate, EG1206A (Pertuzumab biosimilar). Consequently, the company has officially terminated the on-going Phase III clinical trial for EG1206A. This decision accelerates the global marketing authorization applications (BLA/MAA) for the product and reduces the originally planned product development expenses. Receiving positive feedback from regulatory agencies reflects EirGenix’s long-standing expertise in biosimilar development and marks a significant milestone in the company’s expansion in the biosimilar market.

EG1206A is a biosimilar of Perjeta^® (Pertuzumab), a second-generation HER2-targeted monoclonal antibody. EG1206A binds to the HER2 receptor through a unique mechanism, achieving a “dual blockade” effect. When combined with the first-generation Trastuzumab, it provides synergistic benefits for treating HER2-positive early-stage and metastatic breast cancer. Patients with this type of breast cancer account for approximately 20–30% of new breast cancer cases annually. This dual-target therapy significantly improves survival and treatment outcomes and is recommended as a standard treatment in international guidelines for high-risk breast cancer patients.

According to the 2024 annual report from Roche, Perjeta® (Pertuzumab) achieved global sales of CHF 3.616 billion, ranking among Roche’s top-selling products. EG1206A is currently a global frontrunner in pertuzumab biosimilar development. With the Phase III waiver, EirGenix will expedite the preparation of submission package, shortening the time to market and enabling patients in Taiwan, the U.S., Europe, and other global markets to access high-quality, affordable treatment options sooner.

EirGenix has leveraged reverse engineering technology to develop multiple biosimilar products. In addition to five HER2-targeted antibody products under development, the company plans to expand its proprietary product portfolio and CDMO services for biosimilar development and manufacturing. With the latest global regulatory trends and the surge of innovative biologics and expiring patents, between 2025 and 2029, 24 drugs with annual revenues exceeding USD 1 billion will lose patent exclusivity, and another 24 blockbuster drugs will follow between 2030 and 2034, along with over 70 smaller products. This underscores the inevitable and growing demand for biosimilar development and manufacturing. Leveraging its specialized biosimilar technology and large-scale manufacturing expertise, EirGenix is capturing the attention of global pharma companies and is poised for dynamic growth in the global market. Concurrently, the company’s two production lines at its Zhubei commercial plant are reporting a significant increase in utilization rates, underscoring EirGenix's emerging strength and rapid growth trajectory in the global biosimilar sector.