PharmaEssentia Completes Application to Macau Drug Regulatory Authority for Pre-Approval of BESREMi (Ropeginterferon alfa-2b) with New Indication for Essential Thrombocythemia (ET)

1. Date of Event: 115/07/21 2. Name or Code of New Drug in Development: BESREMi (Ropeginterferon alfa-2b, also known as P1101) 3. Indications: (1) Treatment of adult patients with essential thrombocythemia (ET) who have shown resistance or intolerance to hydroxyurea therapy (2) Treatment of adult patients with polycythemia vera without symptomatic splenomegaly 4. All Planned Development Stages: Application for additional indication under the 'Pre-Approval of Imported Drugs' program 5. Current Development Stage (Please specify whether the stage involves submission, approval, or rejection. If rejected, describe risks and countermeasures; also describe future business direction and cumulative R&D expenses incurred): (1) Status of submission/approval/rejection, results of clinical trials (including interim analyses), or other significant events affecting drug development: The Company has completed submitting an application to the Macau Drug Regulatory Authority for an additional indication for BESREMi (Ropeginterferon alfa-2b) under the 'Pre-Approval of Imported Drugs' program. The new indication is for the treatment of adult patients with essential thrombocythemia (ET) who are resistant or intolerant to hydroxyurea therapy. (2) Risks and countermeasures if not approved by the competent authority, if clinical trial results fail to achieve statistical significance, or if other significant events occur: Not applicable. (3) Future business direction if approved by the competent authority and clinical trial results achieve statistical significance: Not applicable. (4) Cumulative R&D expenses incurred: For strategic marketing considerations and to protect the interests of the Company and its investors, this information will not be disclosed at this time. 6. Next Development Stage (Please specify expected completion time and anticipated obligations): Review of the application for additional indication under the 'Pre-Approval of Imported Drugs' program (1) Expected completion time: The actual review timeline and final approval decision will be subject to official notification from the Macau Drug Regulatory Authority, in accordance with their review procedures. (2) Anticipated obligations: None. 7. Market Status: Essential thrombocythemia (ET) is a type of myeloproliferative neoplasm (MPN), with a patient population similar in size to that of polycythemia vera (PV). Market research estimates approximately 1,000 ET patients in Macau. Currently, the first-line treatment for ET is off-label use of hydroxyurea (HU), while 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 entity is a publicly listed company or above, this announcement also qualifies as a material event under Article 7, Paragraph 8 of the Enforcement Rules of the Securities and Exchange Act, significantly impacting shareholder rights or securities prices): (1) Ropeginterferon alfa-2b was approved by the Macau Drug Regulatory Authority in September 2022 for 'Pre-Approval of Imported Drugs' 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 the treatment of 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 or intolerant to hydroxyurea therapy. 9. New drug development involves long timelines, high investment costs, and no guarantee of success, which may expose investors to risks. Investors should carefully evaluate and proceed with caution.