Mr. Lee-Cheng Liu, President of EirGenix, said via an earnings call on 3 December that the new breast cancer biosimilar EG12014 will be submitted to FDA by strategic partner Sandoz in the first half of the year, with the goal of obtaining a drug license for marketing by the end of the year; while the new generation of breast cancer biosimilar EG1206A is planned to be licensed in the second half of the year and launched in 2026.

In addition, TSY-0110 (EG12043), a new ADC drug, is expected to be introduced in 2022 under a US$30 million license, and is expected to meet with FDA on January 30 for clinical phase I design consultation.

Investors and analysts focused on EirGenix previous inspection by FDA with the feedback on manufacuturing process.

According to Liu, FDA shall make the review decision within 6 months after accepting the application, and if it goes well, the drug license will be obtained by the end of 2023.

In addition, the application of EG12014 in Europe has been made and the result is expected to be available by the end of July. Taiwan's drug license application was also submitted on September 30, 2022, and the partner received a notice of approval in December. At present, the scale of the branded drug is about $2 billion, EirGenix aims to reach 10-30% market share in 3 years.

SANDOZ expects to achieve a market share of 8-10% for EG12014, which has five competitors in the US, and will seek to license EG1206A, a next-generation HER2 biosimilar, after completing PK (pharmacokinetics) in the first half of 2023. EG1206A is expected to be licensed for more than EG12014 as there are currently only two competitors in the market, and a successful launch in the US in 2026 would accelerate sales and increase market share for both products.

In addition to the development of biosimilars, EirGenix's other main business, CDMO, will have a project value of NT$1.75 billion in 2022, an annual increase of more than 20%. The company has a chance to turn a profit in 2023 with the approval of its drugs.