The global Contract Development and Manufacturing Organization (CDMO) industry, which experienced a downturn last year, is expected to rebound this year, with analysts anticipating a resurgence. EirGenix Inc., with CDMO business as one of its two major pillars, has seen a recovery in its CDMO business since the fourth quarter of last year, with a quarterly increase of 45%. The company's CDMO business is expected to return to double-digit growth this year, while its in-house product line, including the breast cancer biosimilar drug EG12014, is aiming to obtain US FDA approval in the second half of the year. There is also an opportunity for licensing for EG1206A by the end of the year, making it a product with deeper market expectations.
EirGenix's in-house product line development revolves around a series of products for breast cancer biosimilar drugs. Among them, EG12014, a biosimilar of Herceptin, had its US FDA application previously pending due to deficiencies such as filling freeze-drying equipment. The market expects the deficiencies to be addressed by the end of the first quarter, with successful approval anticipated in the second half of the year. This will mark a milestone achievement, and the company aims to target double-digit market share with strategic partner Sandoz, offering prices relatively lower than competitors.
The next-generation product, EG1206A, is a biosimilar of Perjeta. EirGenix is estimated to be among the top two global developers in terms of development progress. Clinical Phase III trials are expected to commence this year, and the market is optimistic about licensing opportunities. Given the relatively few competitors for this drug, analysts believe that if clinical trials and FDA approval proceed smoothly, market share could reach around 20% within three years of market launch. EirGenix is expected to return to profitability as early as 2025.
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