EIRGENIX'S PHASE III CLINICAL TRIAL OF EG12014 HAS ENROLLED FIRST PATIENT
EIRGENIX'S PHASE III CLINICAL TRIAL OF EG12014 HAS ENROLLED FIRST PATIENT
EirGenix's EG12014 has been approved for phase III clinical trial by the US FDA, Taiwan FDA, and authority from Georgia, Russia, Belarus, South Korea, India, Chile and Ukraine, and first patient has enrolled. This trial will conduct in multi countries, and is expected to complete in 2020 and apply for NDA in the US and Europe.
This international phase III clinical trial will be a large case of biosimilar in Taiwan in recent years, and it will increase the competitiveness of drug development for Taiwan.
2018-10-30
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
2021/03/02
VSTRIP® COVID-19 ANTIGEN RAPID TEST VALIDATED AND APPROVED IN INDIA!
Vstrip® COVID-19 Antigen Rapid Test Validated and Approved in India!
2020/09/26
EIRGENIX RECEIVES APPROVAL FROM JAPAN'S PMDA
2020/02/03
EIRGENIX HOLDS ITS PRE-IPO PRESS CONFERENCE
2019/05/29
EIRGENIX RECEIVED "ASIA'S BEST CMO"
2018/01/31
EIRGENIX DEVELOPS AND MANUFACTURES BIOLOGICS
2013/12/06
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