PharmaEssentia announced on March 1 that it has submitted a supplemental New Drug Application (sNDA) to the South Korean Ministry of Food and Drug Safety (MFDS) for Ropeginterferon alfa-2b (Ropeg) to treat Essential Thrombocythemia (ET).

• Regulatory Timeline: With a standard review period of 8 to 12 months, approval is anticipated by Q4 2026. This follows the granting of Orphan Drug Designation (ODD) in December 2025 based on the positive SURPASS-ET Phase III trial results.
• The "Five-Country" Strategy: PharmaEssentia expects ET approvals across Taiwan, Japan, the U.S., and China within 2025. Adding South Korea to the list, the company aims for a coordinated five-nation launch in 2026, establishing ET as the "second growth engine" alongside its existing Polycythemia Vera (PV) indication.
• Market Advantage: In Korea, ODD status provides significant benefits, including exemptions from local bridging trials and post-approval batch release testing (QC), significantly reducing time-to-market. Ropeg already has a solid commercial foundation in Korea, having been included in the national health insurance reimbursement for PV in August 2025.

Resource: 藥華藥 Ropeg 申請韓國 ET 藥證 預計第4季取證 2026拚五國藥證齊發