PharmaEssentia's Ropeg Recommended by U.S. NCCN for Fourth Consecutive Year, Accelerating MPN Market Expansion

PharmaEssentia (6446-TW) announced today (24th) that its novel drug Ropeg has been recommended by the U.S. National Comprehensive Cancer Network (NCCN) for the fourth consecutive year, solidifying its leadership position among treatment options for two myeloproliferative neoplasm (MPN) indications—polycythemia vera (PV) and essential thrombocythemia (ET)—and accelerating its MPN market expansion.

PharmaEssentia stated that the U.S. NCCN updated its MPN treatment guidelines on September 18, with Ropeg currently being the only drug listed as a preferred regimen for both high-risk and low-risk PV treatments. This is expected to positively influence insurance policies and reimbursement strategies for Ropeg in the U.S. PV market.

Additionally, PharmaEssentia noted that the updated guidelines have added footnotes regarding Rusfertide, a PV drug recently approved by the FDA. The guidelines indicate that, depending on patient risk stratification and clinical status, Rusfertide may be used as a substitute for or in combination with cytoreductive therapy under limited conditions specified in the guidelines. However, if a patient requires cytoreductive therapy due to leukocytosis or other disease-related manifestations, Rusfertide cannot replace such therapy. PharmaEssentia welcomed the increasing number of pharmaceutical companies investing in developing treatment options for the MPN field.

Regarding the ET indication, PharmaEssentia mentioned that Ropeg continues to be recommended by NCCN as a Category 1 preferred therapy for high-risk ET patients who respond poorly or fail to respond to current treatments. The company maintains active and close communication with the NCCN MPN Expert Panel and has already submitted results from further clinical studies to NCCN, suggesting that Ropeg may be recommended for broader PV and ET patient populations in the future.

To strengthen its presence in the U.S. market and enhance scientific and medical communication with clinicians and medical experts, PharmaEssentia has recently expanded its Medical Science Liaison (MSL) team and recruited experienced senior executives to help the MPN medical community stay up-to-date with the latest clinical research data and regulatory approvals in real time.

On new indication development, the Phase III clinical trial (HOPE-PMF) evaluating Ropeg for prefibrotic primary myelofibrosis or overt primary myelofibrosis with low or intermediate-1 risk received positive feedback from the Data Safety Monitoring Board (DSMB) after recent review, recommending continuation per original plan. The main trial is expected to be completed in 2027, injecting new momentum into the company's long-term strategy in the MPN field.