EirGenix's Breast Cancer Biosimilar EG1206A Meets Phase 1 Trial Goals

08 May 2023 | Monday | News

EirGenix, Inc. (6589.TT) announced on 28th of April that it has completed the phase 1 clinical trial (EGC101) of its second breast cancer biosimilar EG1206A in Europe.
Image Source : Public Domain

Image Source : Public Domain

Comparing EG1206A to Roche's Perjeta® US and EU, results of the clinical data analysis show that the main test indicators have met the pharmacokinetics bioequivalence standard. EG1206A is a biosimilar drug of the second-generation HER2-positive antibody drug Perjeta® (pertuzumab). EG1206A has a unique binding mechanism for HER2 receptors which can produce a dual blockade effect. In combination with the first-generation HER2-positive antibody drug Trastuzumab, Pertuzumab has a synergistic effect in the treatment of early-stage HER2-positive breast cancer and metastatic breast cancer.

The success of EG1206A's phase 1 clinical trial is an important milestone for EirGenix and its development of biosimilar drug products for the treatment of HER2-positive breast cancer. Following the product launch of its first biosimilar drug EG12014 (trastuzumab biosimilar), EG1206A will soon begin its multi-country, multi-center global phase 3 clinical trials. After the initiation of the phase 3 clinical trials, it is expected that the evaluation of the primary end point indicators will be completed within two (2) years. Concurrently, EirGenix has been negotiating with global pharmaceutical companies for licensing marketing rights of EG1206A to further fast-track the launch of the biosimilar into the global market. Such achievements in EirGenix's product development bring great excitement to the future of Taiwan's biotechnology industry.


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