On December 15, 2025 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported key accomplishments from 2025 and provided an overview of strategic priorities and anticipated milestones for 2026. The Company also announced its attendance at the 44th Annual J.P. Morgan Healthcare Conference, with a presentation scheduled for Thursday, January 15 at 10:30 a.m. PT (1:30 p.m. ET).
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"PharmaEssentia delivered a year of substantial progress in 2025, driven by the strong performance of BESREMi and preparation for continued growth supported by exceptional commercial execution and important pending product milestones," said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia. "BESREMi has become a key growth engine for our company with the potential to transform treatment across multiple patient populations living with serious myeloproliferative neoplasms (MPNs). In 2025, we saw strong performance in polycythemia vera (PV) and are well positioned for further acceleration. With our injection pen submitted to the FDA and a supplemental BLA under review for the essential thrombocythemia (ET) indication, we are preparing for meaningful opportunities to expand adoption and patient reach. Alongside these anticipated 2026 catalysts, we continue to advance our pipeline, including the ongoing Phase 3 study evaluating BESREMi in pre-fibrotic/early primary myelofibrosis (Early PMF), and preparing to move additional earlier-stage programs into the clinic."
2025 Major Accomplishments
Commercial Performance of BESREMi
Delivered strong commercial growth of BESREMi in PV, with substantial year-over-year revenue growth (Q3 2025 revenue of $127.8 million, representing 44% YoY growth)
Strengthened commercial and medical affairs readiness for anticipated 2026 product launches
Regulatory & Clinical Progress
Submitted the BESREMi injection pen presentation to the FDA for review
Submitted supplemental BLA seeking BESREMi label expansion for ET based on positive head-to-head Phase 3 results
Continued global enrollment in the Phase 3 trial in Early PMF
Earlier Stage Program Progress
Advanced six high value programs to the IND-enabling stage:
PEG-IL-2 and P11838 for immunology and inflammation indications
PD-1–IL-2 immunocytokine for solid tumors
Dual-targeting LILRB1/2 monoclonal antibody for solid tumors
Novel ADC candidate for solid tumors
KRAS and NY-ESO TCR-T cell therapies for solid tumors
2026 Anticipated Milestones
BESREMi
U.S. launch of BESREMi Pen expected (H1 2026)
Potential FDA approval and commercial launch of ET indication (H2 2026)
Completion of enrollment in the global Early PMF Phase 3 clinical trial (H1 2026)
Pipeline & Portfolio Growth
File IND submissions for multiple earlier-stage pipeline programs
Share initial clinical results from multiple earlier-stage programs
(Press release, PharmaEssentia, DEC 15, 2025, View Source [SID1234661449])