PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), announced that Taiwan's Ministry of Health and Welfare (MOHW) has approved ropeginterferon alfa-2b-njft (BESREMi) for the treatment of adult patients with essential thrombocythemia.
This approval represents the first new therapy for ET in almost 30 years and the first global approval of BESREMi for this indication.
Essential thrombocythemia (ET) is a chronic myeloproliferative neoplasm (MPN) characterized by excessive platelet production and an increased risk of blood clots and bleeding complications.
PharmaEssentia said the approval is a key step in its strategy to expand BESREMi across the MPN franchise globally, including the United States, where the FDA is currently reviewing a supplemental BLA with a PDUFA target date of August 30, 2026.
The company highlighted data from the Phase 3 SURPASS-ET and Phase 2 EXCEED-ET studies, which showed that BESREMi has the potential to deliver durable hematologic and molecular responses across a broad ET patient population, supporting its potential as a disease-modifying therapy.
Ko-Chung Lin, Founder and Chief Executive Officer of PharmaEssentia, said the approval strengthens the company's leadership in MPNs and positions BESREMi for significant global growth. He added that the differentiated dosing schedule and clinical profile support its use across a wide range of ET patients.
TWSE: 6446 has traded between TWD 440.65 and TWD 1,020 over the past year. The stock closed Wednesday's trading at TWD 986, down 0.40%.
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