PharmaEssentia held a press conference on the 19th to outline multiple business updates. CEO Ko-Chung Lin revealed that in addition to building its manufacturing base in Taiwan, the company is also evaluating an investment of more than US$50 million (approximately NT$15.6 billion) to establish a new protein active pharmaceutical ingredient (API) manufacturing facility in the United States. Construction is expected to begin in the first half of next year and be completed by the end of next year.
PharmaEssentia stated that its novel drug ropeginterferon alfa-2b (Ropeg) submitted a Biologics License Application to the U.S. Food and Drug Administration (FDA) in October for a new indication, essential thrombocythemia (ET), with the goal of obtaining approval in the second half of 2026. In addition, the company’s board recently approved the appointment of Barry Flannelly, former General Manager of North America at Incyte, as an independent director of PharmaEssentia’s U.S. subsidiary. Lin noted that as progress toward ET approval continues and with Flannelly joining the team, the company aims to jointly capture the myeloproliferative neoplasm (MPN) market, targeting a tenfold increase in revenue.
Flannelly said that under his leadership, Incyte’s annual revenue surged from US$510,000 in 2014 to US$4.2 billion in 2024, while the company’s market capitalization also rose sharply, from US$8 billion in 2014 to more than US$20 billion in 2024. Now joining PharmaEssentia, he expressed strong confidence in Ropeg’s market potential in the MPN field.
Lin added that PharmaEssentia’s Zhubei plant is scheduled to commence production in October next year. However, to support the launch of additional products in the future, the company does not rule out investing more than US$50 million in the first half of next year to build a new U.S. facility dedicated to protein-related APIs. The overall construction plan is targeted to start in the first half of next year and be completed by the end of the year.
PharmaEssentia noted that regulatory filings for Ropeg’s new ET indication have been submitted sequentially in mainland China, Taiwan, Japan, and the United States. In the U.S., this marks the industry’s first application to the FDA for an ET indication in nearly 30 years, with approval targeted for 2026. The FDA has notified the company that if no additional comments are raised within 60 days from receipt, the application will formally enter substantive review on December 29, 2025, in accordance with regulations.
Currently, the main treatments for ET are hydroxyurea (HU) and anagrelide (ANA), but their efficacy and tolerability remain limited. Ropeg not only offers the potential for superior outcomes compared with existing therapies, but also has the potential to become the first FDA-approved drug indicated for both polycythemia vera (PV) and ET, addressing urgent unmet medical needs in the MPN field and leading the MPN market.
Samuel Lin, Vice President of Operations and Strategy at PharmaEssentia USA, stated that the company has already implemented a comprehensive strategy to enter the ET market, including early deployment of U.S. sales, medical affairs, marketing, and market access functions. The sales team has also completed expansion and training this year. PharmaEssentia has applied to include Ropeg in the U.S. National Comprehensive Cancer Network (NCCN) Guidelines as a recommended treatment option for ET patients, and hopes to expand the recommendation to a broader ET population.
Jason Mitch, Vice President of Market Access, also shared updates on market access progress, noting that the company has begun pre-launch communications and strategic planning with major insurance providers. Typically, market access preparation takes more than one year, but as this is an additional indication, the preparation timeline can be significantly shortened.
PharmaEssentia’s U.S. team has been deeply established in the local PV market for many years, building a comprehensive physician network and extensive commercialization experience. As ET and PV patients are both treated by MPN specialists, once Ropeg secures ET approval, U.S. ET patients will be able to benefit immediately. With rapid market expansion, the ET indication is expected to inject new growth momentum into company revenue in 2026, becoming a second growth engine and driving a new wave of explosive revenue growth.
Resource: 藥華藥ET新藥明年上市 繼台灣廠後明年上半年再投逾15億元美國建新廠
