PharmaEssentia announced on December 9 that the regulatory process for Ropeg (P1101) for the treatment of Essential Thrombocythemia (ET) in the U.S. is progressing smoothly. The company completed its Application Orientation Meeting (AOM) with the U.S. FDA on December 8.

The AOM Milestone:

• Focus: The AOM is the first formal meeting following an NDA submission. PharmaEssentia’s team, led by Dr. Zimmerman (VP of Medical & R&D, U.S. subsidiary), guided FDA reviewers through the submission architecture, mechanism of action, and safety summaries. Dr. Qin Xiao-qiang (Chief Medical Officer) presented results from the SURPASS ET and EXCEED ET studies, while lead investigator Dr. Ruben Mesa summarized the clinical benefits.
• Evidence Base: The FDA confirmed the global Phase 3 SURPASS ET as the pivotal study and the U.S. Phase 2 EXCEED ET as confirmatory evidence.
• Market Outlook: There are approximately 150,000 ET patients in the U.S. primarily treated with Hydroxyurea (HU) or Anagrelide (ANA), which have limited tolerability. Ropeg is already approved in ~50 countries for Polycythemia Vera (PV).
• Timeline: PharmaEssentia submitted the sNDA in late October 2025. If no objections are raised within 60 days, the case will enter substantive review on December 29, 2025, with expected approval in 2026. The company has also applied for Priority Review and holds Orphan Drug Designation (ODD).

Resource: 藥華藥完成與FDA首次會議 ET藥證拚2026取證