PharmaEssentia announced on the 5th that its September revenue reached NT$1.32 billion, up 3.43% month-over-month and 41.34% year-over-year. Cumulative revenue for the first three quarters of 2025 reached NT$10.75 billion, representing a 61.14% increase over the same period last year. This milestone marks the first time the company’s nine-month revenue exceeded NT$10 billion, surpassing full-year 2024 revenue and setting a new operational benchmark. The company stated that the U.S. and Japan sales teams have completed expansion and training, which is expected to gradually generate results in Q4 and provide additional momentum for next year’s revenue.
PharmaEssentia indicated that September revenue was primarily driven by its rare blood cancer therapy Ropeginterferon alfa-2b (Ropeg). In particular, shipments to the U.S. market reached a new record, reflecting growing demand. Ropeg has been approved for use in polycythemia vera (PV) patients in nearly 50 countries worldwide, with marketing authorization expected in Mexico by year-end.
Regarding new indications, the essential thrombocythemia (ET) regulatory submission is accelerating. Filings in China, Taiwan, and Japan have already been completed this year. The U.S. FDA has agreed to allow PharmaEssentia to submit directly. The company plans to file in the U.S. in Q4 and will seek priority review designation. If granted, U.S. approval could be achieved as early as H1 2026; under standard review, approval is expected in H2 2026. PharmaEssentia views ET as a potential second growth engine for operations.
The Phase III SURPASS ET trial of Ropeg in ET is set to be published in the internationally renowned hematology journal The Lancet Haematology, with hematology expert Dr. Ruben A. Mesa as corresponding author. This study continues to receive global recognition, highlighting Ropeg’s clinical value in ET treatment and serving as a critical reference for future regulatory approvals and clinical applications. Following presentations at ASCO and EHA this year, the company plans to report results at the ASH Annual Meeting, further enhancing Ropeg’s visibility and influence across the three major international hematology conferences.
PharmaEssentia is actively expanding its multi-indication portfolio to build a long-term growth trajectory. In the myeloproliferative neoplasm (MPN) space, the company has initiated the global Phase III HOPE-PMF trial of Ropeg for early-stage primary myelofibrosis (PMF) patients, to be conducted simultaneously in Taiwan, the U.S., Japan, and China, targeting 150 participants. Following the first patient dosing in Japan on August 8, the first patient in Taiwan was dosed at National Taiwan University Hospital on October 1, with multiple participants already enrolled and clinical progress steadily advancing.
Ropeg’s potential in PMF is supported by robust clinical trial data. The Phase II IIT P1101MF trial, led by Professor Gill of the Hematology Department at Queen Mary Hospital, University of Hong Kong, demonstrated Ropeg’s therapeutic potential in PMF. Positive results were presented orally at the 2025 EHA Annual Meeting, attracting nearly 1,000 professionals and reflecting Ropeg’s high profile in the international hematology-oncology community. Ropeg is expected to offer new treatment options for PMF patients, addressing unmet medical needs.
Resource: 藥華藥9月營收13億元、月增3.4% 年增41% 前三季首度突破百億元大關
