TAIPEI, Nov. 23, 2023 /PRNewswire/ -- EirGenix Inc. (6589. TT) announced today that its trastuzumab biosimilar medicine (EG12014) which their commercial partner Sandoz plans to commercialise (150 mg, for intravenous use) had received a marketing authorization from the European Commission (EC). The marketing authorization in the EU will cover the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, which are the same indications approved by the EC for the reference biologic, Herceptin®.
TAIPEI, May 3, 2023 /PRNewswire/ -- 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. 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.
Sandoz submits BLA for proposed biosimilar trastuzumab to US FDA
TAIPEI, March 24, 2021 /PRNewswire/ -- In a press conference today, EirGenix, Inc. (6589.TT) announced that the Phase III clinical trial (Trial No.: EGC002, NCT03433313) of its breast cancer biosimilar, EG12014 (proposed trastuzumab biosimilar, also called EGI014), has met its primary endpoint. EG12014 has shown equivalent efficacy to Herceptin® in regards to its clinical response (pathologic complete response, pCR), in addition to demonstrating a comparable safety profile. EirGenix will proceed with the preparations for submissions of Biologics License Application (BLA) to the U.S. FDA, Market Approval Application (MAA) to European Medicines Agency (EMA) and New Drug Application to TFDA, exact timings remain confidential.
When Opko Health bought Ireland’s EirGen in 2015, colleagues Sharon Cunningham and Orlaith Ryan wasted no time. Zeroing in on gaps in cancer care, the duo started building its own oncology company, with a focus on children’s and women’s cancers.