EirGenix Inc., submitted the biosimilar drug Eirgasum of 150 mg powder for concentrate for solution for infusion presentation New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA). The treatment of HER2 overexpressing early breast cancer, metastatic breast cancer and metastatic gastric cancer. Once EG12014 is approved in Taiwan, it will have a positive impact on EirGenix's business operation in the future It was agreed to not to disclose this information in publicly in order to protect the company and investors' rights according to the signed confidentiality agreement with Sandoz AG.

After the TFDA receives the application, within 42 days they will assess the completeness of the submitted document package and decide on its acceptance. The review time is based on the NDA process for biosimilar drugs announced by TFDA. EirGenix has several consultation meetings and pre-market evaluation with CDE during the drug development stage and expects the review time of NDA can be accelerated, however, the actual review and approval time of BLA are the decision of the TFDA and are subject to the official notification of the TFDA.