PharmaEssentia recently announced that the Taiwan's Ministry of Health and Welfare (MoHW) has approved ropeginterferon alfa-2b-njft (BESREMi) for the treatment of adult patients with Essential Thrombocythemia (ET). BESREMi is the first new therapy approved for ET in nearly 30 years.

The approval represents the first global regulatory approval of BESREMi in ET and marks an important milestone in the strategy to expand BESREMi across myeloproliferative neoplasms (MPNs). With the first global approval in ET now secured in Taiwan, BESREMi is well-positioned to address a significant global market opportunity, including in the US, where the US Food and Drug Administration (FDA) is currently reviewing a supplemental Biologics License Application (sBLA) for ET with a Prescription Drug User Fee Act (PDUFA) target action date of August 30, 2026.

ET is a chronic MPN characterised by excessive platelet production and increased risk of thrombosis, hemorrhage. Based on data from the phase 3 SURPASS-ET and phase 2 EXCEED-ET studies, PharmaEssentia believes BESREMi has the potential to address a broad ET patient population regardless of underlying disease subtype, supporting a significant global expansion opportunity for the BESREMi franchise.

Ko-Chung Lin, PhD, Founder and Chief Executive Officer (CEO), PharmaEssentia, said, “This first global approval of BESREMi in ET represents an important strategic milestone for PharmaEssentia and further strengthens the company’s leadership position in myeloproliferative neoplasms. We believe ET represents a major long-term growth opportunity for BESREMi and has the potential to significantly expand the reach of the company’s hematology franchise globally. This approval also advances our broader strategy to expand the global BESREMi franchise as we continue preparations for a potential US approval and commercial launch in ET later this year.”

The TFDA approval was supported by data from the global phase 3 SURPASS-ET study, which evaluated ropeginterferon alfa-2b in high-risk ET patients resistant or intolerant to hydroxyurea. Specifically, in the global phase 3 trial SURPASS-ET, BESREMi demonstrated a superior durable clinical response rate compared to anagrelide (42.9 percent vs. 6 percent; p=0.0001). Across clinical studies, BESREMi demonstrated clinically meaningful hematologic responses, molecular responses, and a manageable safety profile.

Dr. Lin continued, “Data generated across the phase 3 SURPASS-ET study and the phase 2b EXCEED-ET trial demonstrated the potential of ropeginterferon alfa-2b to achieve durable hematologic and molecular responses in ET patients, supporting the potential for durable hematologic and molecular responses consistent with disease-modifying activity in ET. We believe the differentiated profile and dosing schedule of BESREMi position BESREMi as a differentiated treatment option for a broad range of ET patients.”

In addition to the ongoing FDA review of the ET sBLA, ropeginterferon alfa-2b has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for the treatment of ET, further supporting increasing adoption of interferon-based treatment approaches in ET and other MPNs.

PharmaEssentia is the inventor and owner of BESREMi (ropeginterferon alfa-2b-njft) and maintains Intellectual Property (IP) rights for the product across all indications.