EirGenix is ramping up its new drug development efforts. Among the notable projects is the biosimilar for breast cancer treatment, EG12014, which comes in a 150mg lyophilized injection. Their partner, Sandoz, submitted a license application to the US FDA in June, with the review expected to be completed by the fourth quarter. Additionally, a 420mg dose is anticipated to be submitted to the FDA by Sandoz in the third quarter of next year, adding momentum to their operations.
EG12014, along with Tanvex BioPharma's biosimilar filgrastim (TX01) for treating neutropenia, faced initial setbacks with the US FDA. However, with TX01 now FDA-approved, there is renewed optimism for EG12014, which could potentially receive approval as early as the fourth quarter.
Despite the challenges in the US, EG12014 has received marketing authorization in the EU and was also approved by Taiwan's TFDA in May 2023. This makes it the first HER2-targeted biosimilar for breast cancer developed and manufactured by a Taiwanese pharmaceutical company to seek global marketing approval. In October 2023, it also gained approval for health insurance coverage, priced at NT$11,323 per injection, roughly 80% of the original drug's price. Several hospitals have already adopted it for patient use.
Boosted by its CDMO (Contract Development and Manufacturing Organization) business, EirGenix reported revenue of NT$466 million for the first half of this year, a year-on-year increase of 31.4%. The high visibility of orders for its animal cell and microbial production facilities has led to near-full capacity at the Xizhi microbial plant, driven by increased orders from Japanese clients. To meet this demand, the plant will operate on a two-shift system to increase production capacity in the second half of the year.
EirGenix stated that it is in discussions with two commercial-scale production clients in Japan regarding orders for 2026. The company is also accelerating the construction of the Zhubei Building B microbial plant, aiming for completion by the end of 2025, which will add a capacity of 1,350 liters.
Resource (mandarin): 台康生新藥開發催油門
