PharmaEssentia Receives Taiwan Approval for BESREMi in Essential Thrombocythaemia
Thursday, June 11, 2026
PharmaEssentia has received approval from Taiwan’s Ministry of Health and Welfare (MOHW) for BESREMi® (ropeginterferon alfa-2b-njft) to treat adult patients with essential thrombocythaemia (ET). The approval marks the first global regulatory approval of BESREMi for ET and the first new treatment approved for the condition in nearly three decades.
The approval represents an important step in PharmaEssentia’s strategy to expand BESREMi across myeloproliferative neoplasms (MPNs). It also strengthens the product’s commercial potential in global markets, including the United States, where the U.S. Food and Drug Administration is currently reviewing a supplemental Biologics License Application for ET. A regulatory decision is expected by 30 August 2026.
Essential thrombocythaemia is a chronic blood cancer characterised by excessive platelet production, which increases the risk of thrombosis and bleeding. Based on results from the Phase 3 SURPASS-ET and Phase 2 EXCEED-ET studies, BESREMi has shown potential to benefit a broad range of ET patients regardless of disease subtype.
The approval was supported by data from the global Phase 3 SURPASS-ET trial, which evaluated BESREMi in high-risk ET patients who were resistant or intolerant to hydroxyurea. In the study, BESREMi achieved a significantly higher durable clinical response rate than anagrelide, with response rates of 42.9% compared with 6.0%.
Clinical findings also demonstrated meaningful haematologic and molecular responses, along with a manageable safety profile. The results suggest that BESREMi may offer disease-modifying benefits for patients with ET.
In addition to the ongoing FDA review, ropeginterferon alfa-2b has been included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for the treatment of ET. The inclusion supports the growing use of interferon-based therapies in ET and other myeloproliferative neoplasms.
PharmaEssentia is the developer and owner of BESREMi and retains intellectual property rights for the product across all approved and investigational indications.
Source: businesswire.com
