PharmaEssentia: Macau Drug Administration Approves Pre-Import License for BESREMi (ropeginterferon alfa-2b) with New Indication for Essential Thrombocythemia (ET)

1. Date of Event: 115/07/31

2. Name or Code of the Investigational Drug: BESREMi (ropeginterferon alfa-2b, also known as P1101)

3. Indications: (1) Treatment of adult patients with essential thrombocythemia 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: Not applicable.

5. Current Development Stage (please specify whether the stage involves application submission/approval/rejection; if rejected, describe risks and mitigation measures; also include future business direction and cumulative R&D expenses incurred): (1) Application submission/approval/rejection, results of clinical trials (including interim analyses), or other significant events affecting drug development: The Macau Drug Administration has approved a new indication under the 'Pre-Import License' for BESREMi (ropeginterferon alfa-2b), developed by our company. The new indication is for the treatment of adult patients with essential thrombocythemia who have shown resistance or intolerance to hydroxyurea therapy. (2) If not approved by the competent authority, clinical trial results fail to achieve statistical significance, or other significant events occur affecting drug development, describe risks and mitigation measures: Not applicable. (3) Future business direction following approval by the competent authority, achievement of statistical significance in clinical trials, or other significant events: BESREMi (ropeginterferon alfa-2b) will be eligible for market launch and sale in Macau under the newly approved indication. (4) Cumulative R&D expenses incurred: For strategic marketing considerations and to protect corporate and investor interests, disclosure is currently withheld.

6. Next Development Stage (please specify expected completion date and anticipated obligations): Not applicable. (1) Expected completion date: Not applicable. (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, Clause 8 of the Enforcement Rules of the Securities and Exchange Act, significantly impacting shareholder rights or securities prices): (1) Ropeginterferon alfa-2b received approval for the 'Pre-Import License' from the Macau Drug Administration in September 2022, with the indication for polycythemia vera (PV). (2) Ropeginterferon alfa-2b is a next-generation long-acting interferon independently developed and manufactured by our 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. Additionally, it has been approved by Taiwan's Ministry of Health and Welfare for the treatment of adult patients with essential thrombocythemia who are resistant or intolerant to hydroxyurea therapy.

9. Drug development involves long timelines, high investment costs, and no guarantee of success, which may expose investors to risks. Investors are advised to carefully assess and make prudent investment decisions.