PharmaEssentia announced on the 12th that it has completed its final participant enrollment in the global, multi-center Phase III clinical trial (SURPASS ET) for its new drug Ropeg (P1101) targeting essential thrombocythemia (ET). The company expects to receive statistical results on the primary endpoints early next year. Following this, PharmaEssentia plans to apply for ET drug approval in Taiwan, the United States, Japan, South Korea, China, and other markets, positioning Ropeg as a promising growth driver.

Ropeg, a next-generation long-acting interferon developed and manufactured by PharmaEssentia, is already approved in approximately 40 countries for treating polycythemia vera (PV), including major markets such as the U.S., Japan, China, and the EU. ET and PV are both classified as myeloproliferative neoplasms (MPNs), with a similar number of patients affected. Current primary treatment for ET is hydroxyurea (HU), used off-label, but studies indicate that about 20% of ET patients are either intolerant to or develop resistance to HU. Anagrelide, the only FDA-approved second-line treatment, is prescribed for patients who cannot tolerate or do not respond to HU.

CEO Ko-Chung Lin emphasized the significance of this milestone, noting that the U.S. FDA has not approved a new ET treatment in over 20 years. The FDA’s approval of Ropeg for Phase III trials in ET was highly anticipated, and the completion of these trials represents a substantial achievement.

Following positive clinical outcomes of Ropeg for PV, PharmaEssentia initiated the SURPASS ET trial after consultations with the FDA. The study compares the efficacy, safety, and tolerability of Ropeg versus Anagrelide in ET patients. The trial spans the U.S., Japan, Taiwan, South Korea, Hong Kong, China, Singapore, and Canada, enrolling a total of 174 participants.

Additionally, PharmaEssentia has concluded patient enrollment for its single-arm EXCEED ET trial in the U.S. and Canada. Driven by high interest from both physicians and patients, the trial quickly surpassed its initial target of 64 enrollees, reaching 91 participants—142% of the original goal. This robust enrollment underscores strong confidence among clinical researchers in Ropeg’s efficacy and safety, likely boosting future applications for ET drug approval.

PharmaEssentia anticipates receiving statistical data on the SURPASS ET trial’s primary endpoints early next year, with global regulatory submissions for ET approval to follow. The company is now actively preparing for pre-marketing efforts.

Resource (mandarin): 藥華藥新藥全球第三期臨床試驗完成 預計2025年初解盲