TaiRx (6589) reported October 2026 revenue exceeding NT$270 million, with cumulative January-October 2026 revenue reaching NT$1.38 billion—a 94.7% year-over-year increase—marking three-year highs for both monthly and cumulative revenue. The growth stems from expanding CDMO operations and global licensing revenue from biosimilar candidates EG12014 and EG1206A. Chairman Liu Li-cheng attributed the performance to the company's dual-engine strategy combining contract development and manufacturing services with proprietary biosimilar development.
TaiRx Submits EG1206A Regulatory Filings to EMA, FDA, and Canadian Authorities
TaiRx submitted a Marketing Authorization Application (MAA) for biosimilar EG1206A to the European Medicines Agency (EMA) in late October 2026. The company plans to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) and submit an application to Canadian regulatory authorities by the end of 2026. In the first half of 2027, TaiRx and partner Sandoz plan to file applications in 26 countries, with a simultaneous submission to Taiwan's Food and Drug Administration (TFDA) during the same period.
Company Targets 2027 Europe Launch and 2028 US Launch for EG1206A
TaiRx targets commercial launch of EG1206A in Europe in 2027 and in the United States in 2028. The company expects major licensing milestone payments to materialize between 2027 and 2028 as regulatory reviews and approvals progress.
TaiRx Plans 2027 Clinical Trial Entry for EG12184 Biosimilar
TaiRx plans to advance biosimilar candidate EG12184—a subcutaneous formulation targeting the multiple myeloma treatment market—into clinical trials in 2027. The company's mid- to long-term goal is to bring one biosimilar product to market readiness every 12 to 18 months starting in 2029.
Zhubo Plant 2 Prepares for PMDA Inspection Ahead of 2027 Japan Shipments
TaiRx's Zhubo Plant 2 facility is preparing for an on-site inspection by Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The company targets initial commercial shipments to Japanese customers in 2027. Chairman Liu stated that the company expects more pronounced improvements in operational scale and profitability structure in the second half of 2027.
FAQ
What revenue did TaiRx report for October 2026?
TaiRx reported October 2026 revenue exceeding NT$270 million, with cumulative January-October 2026 revenue reaching NT$1.38 billion—a 94.7% year-over-year increase. Both figures represent three-year highs for the company.
When did TaiRx submit the EG1206A application to the EMA?
TaiRx submitted the Marketing Authorization Application (MAA) for EG1206A to the European Medicines Agency (EMA) in late October 2026. The company plans to file with the FDA and Canadian authorities by the end of 2026.
