PharmaEssentia Completes Application for BESREMi Label Expansion in Macau

Release Date: 2026-07-22 Statement Date: 2026-07-21 Statement Time: 18:44:08 Company Code: 6446 Company Name: PharmaEssentia Subject: The company has completed the application to the Macau Drug Supervision Authority for the label expansion of BESREMi (Ropeginterferon alfa-2b) under the 'Pre-market Authorization for Imported Drugs,' with the new indication for essential thrombocythemia (ET) Compliance Clause: Clause 10 Factual Date: 2026-07-21 Details: 1. Factual Date: 2026/07/21 2. Name or Code of the New Drug: BESREMi (Ropeginterferon alfa-2b, also known as P1101) 3. Indications: (1) Treatment of adult patients with essential thrombocythemia (ET) who are resistant to or intolerant of hydroxyurea therapy (2) Treatment of adult patients with polycythemia vera (PV) without symptomatic splenomegaly 4. All planned R&D stages: Application for label expansion under 'Pre-market Authorization for Imported Drugs' 5. Current R&D stage (please specify whether the current stage is application submission/approval/rejection; if rejected, describe risks and countermeasures; also describe future business direction and cumulative R&D expenses incurred): (1) Status of submission/approval/rejection, clinical trial results (including interim analyses), or other significant events affecting drug development: The company has completed the application to the Macau Drug Supervision Authority for the label expansion of BESREMi (Ropeginterferon alfa-2b) under the 'Pre-market Authorization for Imported Drugs,' with the new indication for the treatment of adult patients with essential thrombocythemia (ET) who are resistant to or intolerant of hydroxyurea therapy. (2) Risks and countermeasures if not approved by the competent authority, clinical trial results not statistically significant, or other major events affecting drug development: Not applicable. (3) Future business direction if approved by the competent authority, clinical trial results statistically significant, or other major events affecting drug development: Not applicable. (4) Cumulative R&D expenses incurred: For strategic marketing considerations and to protect the interests of the company and investors, cumulative R&D expenses are not disclosed at this time. 6. Next R&D stage (please specify expected completion time and expected obligations): Review of the application for label expansion under 'Pre-market Authorization for Imported Drugs' (1) Expected completion time: In accordance with the review procedures of the Macau Drug Supervision Authority, the actual review duration and approval outcome will be confirmed by official notification from the authority. (2) Expected obligations: None. 7. Market Status: Essential thrombocythemia (ET) is a type of myeloproliferative neoplasm (MPN), with a patient population similar to that of polycythemia vera (PV). Market research estimates approximately 1,000 ET patients in Macau. The current first-line treatment for ET is off-label use of hydroxyurea (HU), and the second-line treatment is anagrelide, which was approved by the U.S. FDA in 1997. 8. Other Matters to be Disclosed (if the subject of the event or resolution is a publicly listed company or above, this material information also complies with Article 7, Clause 8 of the Enforcement Rules of the Securities and Exchange Act regarding matters significantly affecting shareholders' rights or securities prices): (1) Ropeginterferon alfa-2b received 'Pre-market Authorization for Imported Drugs' from the Macau Drug Supervision Authority in September 2022, with the indication for polycythemia vera (PV). (2) Ropeginterferon alfa-2b is a next-generation innovative long-acting interferon independently developed and manufactured by the company. It has been approved in approximately 50 countries worldwide for adult patients with polycythemia vera, including major pharmaceutical markets such as the United States, Japan, China, and the European Union. Ropeginterferon alfa-2b has also been approved by Taiwan's Ministry of Health and Welfare for the treatment of adult patients with essential thrombocythemia (ET) who are resistant to or intolerant of hydroxyurea therapy. 9. New drug development involves long timelines, high investment costs, and no guarantee of success, which may pose investment risks. Investors should carefully evaluate and make prudent investment decisions.