EirGenix expects to respond to the FDA's deficient filing for the biosimilar EG12014 in July at the earliest, and if all goes well, there is still a chance that EG12014 will be approved in the fourth quarter and marketed in the first quarter of next year. EG1206A, a next-generation breast cancer drug, is also attracting attention.

The company pointed out that EG12014 was previously requested by the FDA to follow up with a deficient filing, mainly due to a lack of freeze drying process and equipment. As the strategic partner of the drug is Sandoz, the company is already familiar with the biosimilars, and it is expected to achieve a market share of approximately 8% in two years after its launch in Europe and the US.

In addition to its own products, EirGenix's CDMO business, which is a large-molecule pharmaceutical product with a large scale production capacity, will maintain a steady double-digit growth in the medium to long term, providing the company with stable cash flow.