PharmaEssentia Receives Approval for New Indication for Besremi from Taiwan's Ministry of Health and Welfare

1. Date of occurrence: May 28, 2026 (115/05/28).
2. Name of the new drug: Besremi (ropeginterferon alfa-2b, also known as P1101).
3. Purpose: (1) Treatment of adult patients with essential thrombocythemia (ET) who are resistant or intolerant to hydroxyurea. (2) Treatment of adult patients with polycythemia vera (PV) without symptomatic splenomegaly.
4. All development stages: Not applicable.
5. Current development stage: The company's drug, Besremi 500 mcg/mL solution for injection (License No. 000143), received approval for the new indication from the Ministry of Health and Welfare on May 12, 2026, and the official notification was received on May 28, 2026. The company will proceed with the registration process, apply for national health insurance coverage, and continue marketing activities.
6. Next development stage: Not applicable.
7. Market status: Essential thrombocythemia (ET) is a type of myeloproliferative neoplasm (MPN). According to Taiwan's National Health Insurance database, there are approximately 4,500 ET patients in Taiwan. The current first-line treatment is hydroxyurea, and the second-line treatment is anagrelide.
8. Other information: Ropeginterferon alfa-2b was approved for polycythemia vera in 2020 and included in the national health insurance coverage in 2022. It is currently approved in approximately 50 countries worldwide.