【PharmaEssentia】Company's New Drug BESREMi (Ropeginterferon alfa-2b) Receives Approval Letter from Ministry of Health and Welfare for Use in Essential Thrombocythemia (ET)
PharmaEssentia's new drug BESREMi has received approval from Taiwan's Ministry of Health and Welfare for an expanded indication to treat adult patients with essential thrombocythemia (ET) who are resistant or intolerant to hydroxyurea treatment. This approval expands treatment options for patients and positions the company to pursue National Health Insurance (NHI) coverage and accelerate sales and marketing efforts.
📋 Article Processing Timeline
- 📰 Published: May 12, 2026 at 09:00
- 🔍 Collected: May 13, 2026 at 08:00 (23h 0m after Published)
- 🤖 AI Analyzed: May 13, 2026 at 09:08 (1h 8m after Collected)
1. Date of occurrence of the event: 2026/05/12
2. Name or code of the new drug under development: BESREMi (Ropeginterferon alfa-2b, i.e., P1101, Chinese trade name: 百斯瑞明)
3. Purpose: Treatment of adult patients with essential thrombocythemia who are resistant or intolerant to hydroxyurea treatment.
4. All expected stages of development: Not applicable.
5. Current stage of development (please state whether the current stage of development is applying for/approved/not approved. If not approved, please explain the risks faced by the company and corresponding measures; also explain the future business direction and accumulated R&D expenses):
(1) Applying for/approved/not approved/results of each phase of human trials (including interim analysis)/occurrence of other major events affecting new drug development:
Our company's new drug, Besremi 500 mcg/mL solution for injection in prefilled syringe, has received an approval letter from the Taiwan Ministry of Health and Welfare (hereinafter referred to as the MOHW) for use in essential thrombocythemia (ET). The newly approved indication is for the treatment of adult patients with essential thrombocythemia who are resistant or intolerant to hydroxyurea treatment.
(2) If the competent authority for the target industry has not approved, or the results of each phase of human clinical trials (including interim analysis) have not reached statistical significance, or other major events affecting new drug development have occurred, the risks faced by the company and corresponding measures: Not applicable.
(3) If the competent authority for the target industry has approved, or the results of each phase of human clinical trials (including interim analysis) have reached statistical significance, or other major events affecting new drug development have occurred, the future business direction:
Our company will apply to the National Health Insurance Administration of the MOHW to include BESREMi for essential thrombocythemia in the National Health Insurance coverage, and will continue to conduct BESREMi's sales business and marketing activities.
(4) Accumulated R&D expenses: Considering future market strategies and protecting the rights and interests of the company and investors, this information will not be disclosed for now.
6. Next stage of development (please state the estimated completion time and expected obligations): Not applicable.
(1) Estimated completion time: Not applicable.
(2) Expected obligations: None.
7. Market situation:
Essential thrombocythemia (ET) is a type of myeloproliferative neoplasm (MPN) disease, with a similar number of patients to polycythemia vera (PV). According to research in Taiwan's National Health Insurance database, there are approximately 4,500 ET patients in Taiwan (about 20 ET patients per 100,000 people). Currently, the first-line drug for ET is off-label hydroxyurea (HU), and the second-line drug is anagrelide, which was approved by the US FDA in 1997.
8. Other matters that should be specified (if the subject of the event or resolution is a public offering company or above, this material information also meets the provisions of Article 7, Paragraph 8 of the Enforcement Rules of the Securities and Exchange Act regarding matters that have a material impact on shareholders' equity or securities prices):
(1) Ropeginterferon alfa-2b was approved by the MOHW in 2020 for the treatment of adult patients with polycythemia vera without symptomatic splenomegaly, and was approved by the MOHW's National Health Insurance Administration in 2022 for inclusion in National Health Insurance coverage.
(2) Ropeginterferon alfa-2b is a new generation innovative long-acting interferon independently developed and produced by our company. It has been approved in approximately 50 countries worldwide for adult patients with polycythemia vera, including major new drug markets such as the United States, Japan, China, and the European Union.
9. New drug development is a lengthy process with high investment and no guarantee of success. Such factors may expose investments to risks, and investors should exercise careful judgment and invest cautiously.
2. Name or code of the new drug under development: BESREMi (Ropeginterferon alfa-2b, i.e., P1101, Chinese trade name: 百斯瑞明)
3. Purpose: Treatment of adult patients with essential thrombocythemia who are resistant or intolerant to hydroxyurea treatment.
4. All expected stages of development: Not applicable.
5. Current stage of development (please state whether the current stage of development is applying for/approved/not approved. If not approved, please explain the risks faced by the company and corresponding measures; also explain the future business direction and accumulated R&D expenses):
(1) Applying for/approved/not approved/results of each phase of human trials (including interim analysis)/occurrence of other major events affecting new drug development:
Our company's new drug, Besremi 500 mcg/mL solution for injection in prefilled syringe, has received an approval letter from the Taiwan Ministry of Health and Welfare (hereinafter referred to as the MOHW) for use in essential thrombocythemia (ET). The newly approved indication is for the treatment of adult patients with essential thrombocythemia who are resistant or intolerant to hydroxyurea treatment.
(2) If the competent authority for the target industry has not approved, or the results of each phase of human clinical trials (including interim analysis) have not reached statistical significance, or other major events affecting new drug development have occurred, the risks faced by the company and corresponding measures: Not applicable.
(3) If the competent authority for the target industry has approved, or the results of each phase of human clinical trials (including interim analysis) have reached statistical significance, or other major events affecting new drug development have occurred, the future business direction:
Our company will apply to the National Health Insurance Administration of the MOHW to include BESREMi for essential thrombocythemia in the National Health Insurance coverage, and will continue to conduct BESREMi's sales business and marketing activities.
(4) Accumulated R&D expenses: Considering future market strategies and protecting the rights and interests of the company and investors, this information will not be disclosed for now.
6. Next stage of development (please state the estimated completion time and expected obligations): Not applicable.
(1) Estimated completion time: Not applicable.
(2) Expected obligations: None.
7. Market situation:
Essential thrombocythemia (ET) is a type of myeloproliferative neoplasm (MPN) disease, with a similar number of patients to polycythemia vera (PV). According to research in Taiwan's National Health Insurance database, there are approximately 4,500 ET patients in Taiwan (about 20 ET patients per 100,000 people). Currently, the first-line drug for ET is off-label hydroxyurea (HU), and the second-line drug is anagrelide, which was approved by the US FDA in 1997.
8. Other matters that should be specified (if the subject of the event or resolution is a public offering company or above, this material information also meets the provisions of Article 7, Paragraph 8 of the Enforcement Rules of the Securities and Exchange Act regarding matters that have a material impact on shareholders' equity or securities prices):
(1) Ropeginterferon alfa-2b was approved by the MOHW in 2020 for the treatment of adult patients with polycythemia vera without symptomatic splenomegaly, and was approved by the MOHW's National Health Insurance Administration in 2022 for inclusion in National Health Insurance coverage.
(2) Ropeginterferon alfa-2b is a new generation innovative long-acting interferon independently developed and produced by our company. It has been approved in approximately 50 countries worldwide for adult patients with polycythemia vera, including major new drug markets such as the United States, Japan, China, and the European Union.
9. New drug development is a lengthy process with high investment and no guarantee of success. Such factors may expose investments to risks, and investors should exercise careful judgment and invest cautiously.