CANCER THERAPEUTIC DRUG EG12014 IS APPROVED FOR PHASE III CLINICAL TRIAL
EirGenix's biosimilar drug EG12014 has been approved by US Food and Drug Administration (FDA) and Taiwan Food and Drug Administration (TFDA) for Phase III clinical trial. It is estimated to recruit 800 breast cancer patients around the world for the trial. According to Roche's 2017 annual report, Herceptin's global sales amounted to 7.014 billion Swiss francs. This trial will be a large-scale international one for biosimilar drug in Taiwan in recent years. This trial will increase the competitiveness of drug development in Taiwan.
2018-05-22
Associated News
EIRGENIXは日本市場を拡大するために、日本の会社と長期供給契約の締結について
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EirGenix Inc. Achieves Major Milestone: Breast Cancer Biosimilar Candidate -EG1206A Receives Favorable Response Regarding Phase III Clinical Trial Waiver
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.
2025/10/22