PharmaEssentia announced on September 5 that it has submitted an application to Taiwan’s Food and Drug Administration (TFDA) to expand the indication of its novel drug Ropeginterferon alfa-2b (P1101) to include primary essential thrombocythemia (ET). The company also reported August revenue of NT$1.27 billion, marking the second-highest monthly revenue in its history—slightly down 2.14% from the previous month but up 41.35% year-over-year. U.S. shipments of Ropeg reached a new record high, while sales in Japan were slightly affected by national holidays.
Ropeg has been approved in approximately 50 countries worldwide for the treatment of polycythemia vera (PV), with global usage and sales continuing to grow steadily. In recent years, the company has actively pursued new indications for Ropeg, targeting ET as the first expansion within the myeloproliferative neoplasm (MPN) category. According to Taiwan’s National Health Insurance research database, there are about 4,500 ET patients in the country. Current treatment options include off-label use of hydroxyurea (HU) and Anagrelide (ANA), the only ET therapy approved by the U.S. FDA, though efficacy and tolerability remain limited.
In January 2025, PharmaEssentia reported the global Phase 3 “SURPASS ET” clinical trial results for Ropeg in ET patients. The Ropeg arm demonstrated a significantly higher durable clinical response rate compared with the Anagrelide control group (42.9% vs. 6.0%; p=0.0001), showing clear clinical advantages.
In addition to the Taiwan ET application submitted on September 5, the TFDA review period is expected to take approximately 180 days (excluding any requests for additional information). PharmaEssentia is simultaneously advancing global ET regulatory filings, targeting approvals in 2026, while initiating commercialization plans. In China, the ET application was officially accepted by the National Medical Products Administration on July 16, and the Japanese ET application is expected to be submitted this month. The team also plans to submit the U.S. ET application by the end of the year, with Ropeg already proposed for inclusion in the NCCN ET treatment guidelines in July.
August revenue of NT$1.27 billion represents a 41.35% year-over-year increase and a slight 2.14% decrease from July, establishing the second-highest monthly revenue in company history. Cumulative revenue from January to August reached NT$9.44 billion, up 64.36% year-over-year, approaching the full-year total for 2024. Revenue in August was mainly driven by Ropeg, with U.S. shipments reaching a new record high, while Japanese sales were slightly impacted by national holidays.
PharmaEssentia noted that its U.S. and Japan sales teams have completed expansion and training, which is expected to inject new growth momentum into operations for Q4 and the coming year.
Resource: 藥華藥8月營收寫歷史次高，新藥Ropeg申請臺灣ET藥證
