PharmaEssentia Announces Presentations at ASH 2025

PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced it will be presenting at the 67^th American Society of Hematology (ASH) Annual Meeting, taking place December 6-9 in Orlando, Florida. The Company’s presentations will share new data exploring the clinical and biologic effects of BESREMI® ropeginterferon alfa-2b-njft in polycythemia vera (PV).

“The new data presented at ASH build on the growing body of evidence showing deep and durable responses with ropeginterferon alfa-2b in PV, including molecular and transcriptomic findings that offer insight into potential mechanisms of disease modification,” said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia. “These results expand the evidence supporting the potential of ropeginterferon alfa-2b-njft to transform outcomes for patients with PV.”

Presentation Details

Long-term efficacy and safety of ropeginterferon alfa-2b under its HIDAT regimen for the treatment of polycythemia vera

• Abstract: abs25-10438 (2039)
• Session Type: Poster
• Presenter: Shanshan Suo
• Room: OCCC - West Halls B3-B4
• Date: Saturday, December 6, 5:30 PM - 7:30 PM EST
• Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I

Transcriptomic signatures associated with deep molecular response to ropeginterferon alfa-2b in polycythemia vera

• Abstract: abs25-10525 (2040)
• Session Type: Poster
• Presenter: Seug Yun Yoon
• Room: OCCC - West Halls B3-B4
• Date: Saturday, December 6, 5:30 PM - 7:30 PM EST
• Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I

Rapid JAK2 V617F decline predicts response durability: kinetics of JAK2 V617F in ropeginterferon alfa-2b treated polycythemia vera

• Abstract: abs25-13127 (3819)
• Session Type: Poster
• Presenter: Sung-Eun Lee
• Room: OCCC - West Halls B3-B4
• Date: Sunday, December 7, 6:00 PM - 8:00 PM EST
• Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II

Clinical significance of earlier CHR achievement and long-term CHR maintenance in polycythemia vera patients treated with ropeginterferon alfa-2b

• Abstract: abs25-13190 (5598)
• Session Type: Poster
• Presenter: Sung-Eun Lee
• Room: OCCC - West Halls B3-B4
• Date: Monday, December 8, 6:00 PM - 8:00 PM EST
• Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III

About Polycythemia Vera

Polycythemia vera, or PV, is a rare and chronic blood cancer. It’s part of a group of blood cancers called myeloproliferative neoplasms, or MPNs. PV starts in the bone marrow. Normally the body keeps all types of blood cells in a healthy balance, but with PV, the body produces too many red blood cells and may create excess white blood cells and platelets.

About BESREMi® (ropeginterferon alfa-2b-njft)

BESREMi® is the only FDA-approved treatment indicated for adults with polycythemia vera (PV) that targets the source of the disease. BESREMi® is not chemotherapy, it's an innovative immunotherapy. Ropeginterferon alfa-2b-njft is a preferred first-line cytoreductive therapy option for both low-risk (symptomatic) and high-risk PV in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). National Comprehensive Cancer Network® (NCCN®)–preferred interventions are based on efficacy, safety, and evidence, and when appropriate, affordability.

BESREMi® holds orphan drug designation in the United States for the treatment of polycythemia vera (PV) in adults. It has received regulatory approval in over 40 countries, including from the European Medicines Agency (2019), the U.S. Food and Drug Administration (2021), and the Pharmaceuticals and Medical Devices Agency in Japan (2023). The product was developed by PharmaEssentia and is manufactured at the company’s facility in Taichung. PharmaEssentia retains full global intellectual property rights across all indications.

Indication

BESREMi® is indicated for the treatment of adults with polycythemia vera.

Important Safety Information

Boxed WARNING: RISK OF SERIOUS DISORDERS

Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.

Contraindications

Existence of or history of severe depression, suicidal ideation, or suicide attempt

Hypersensitivity to interferons or any inactive ingredients

Moderate or severe hepatic impairment

History or presence of active serious or untreated autoimmune disease

History of transplantation and receiving immunosuppressant agents

Warnings and Precautions

• Depression and Suicide: Closely monitor patients for any symptoms of psychiatric disorders and, if needed, consider psychiatric consultation and treatment or dosage modifications as listed in the full prescribing information.
• Endocrine Toxicity: Do not use BESREMi® in patients with active serious or untreated endocrine disorders associated with autoimmune disease. Evaluate thyroid function in patients who develop symptoms suggestive of thyroid disease during BESREMi® therapy. Discontinue BESREMi® in patients who develop endocrine disorders that cannot be adequately managed during treatment with BESREMi®.
• Cardiovascular Toxicity: Patients with a history of cardiovascular disorders should be closely monitored for cardiovascular toxicity during BESREMi® therapy. Avoid use of BESREMi® in patients with severe or unstable cardiovascular disease or recent stroke or myocardial infarction.
• Decreased Peripheral Blood Counts: Monitor complete blood counts at baseline, during titration, and every 3-6 months during the maintenance phase.
• Pancreatitis/Colitis/Pulmonary Toxicity: Interrupt BESREMi® treatment in patients with possible pancreatitis, colitis, or pulmonary toxicity and evaluate promptly. Consider discontinuation of BESREMi® in patients with confirmed pancreatitis or who show signs or symptoms of serious ulcerative or hemorrhagic colitis, or who develop pulmonary infiltrates or pulmonary function impairment.
• Ophthalmologic Toxicity: Advise patients to have eye examinations before and during treatment. Discontinue BESREMi® in patients who develop new or worsening eye disorders.
• Hyperlipidemia/Hepatotoxicity/Renal Toxicity: Monitor serum triglycerides, liver enzymes, hepatic function, and serum creatinine at baseline and during therapy. Avoid use of BESREMi® in patients with eGFR <30 mL/min. Discontinue BESREMi® in patients with persistently marked elevated triglycerides, evidence of hepatic decompensation, or if renal impairment develops during treatment.
• Dental and Periodontal Toxicity: Patients should have good oral hygiene and regular dental examinations.
• Dermatologic Toxicity: Consider discontinuation of BESREMi® if clinically significant dermatologic toxicity occurs.
• Driving and Operating Machinery: BESREMi® may impact the ability to drive and use machinery. Patients should not drive or use heavy machinery until they know how BESREMi® affects their abilities. Patients who experience dizziness, somnolence, or hallucination during BESREMi® therapy should avoid driving or using machinery.
• Embryo-Fetal Toxicity: Based on the mechanism of action, BESREMi® can cause fetal harm when administered to a pregnant woman. Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with BESREMi®. Advise females of reproductive potential to use an effective method of contraception during treatment with BESREMi® and for at least 8 weeks after the final dose. Advise women not to breastfeed during treatment and for 8 weeks after the final dose.

Adverse Reactions

The most common adverse reactions reported in >40% of patients were influenza-like illness, arthralgia, fatigue, pruritus, nasopharyngitis, and musculoskeletal pain.

Drug Interactions

Patients on BESREMi® who are receiving concomitant drugs which are CYP450 substrates with a narrow therapeutic index should be monitored to inform the need for dosage modification. Avoid use with myelosuppressive agents, narcotics, hypnotics, or sedatives, and monitor patients receiving the combination for effects of excessive CNS toxicity.

Please see full Prescribing Information, including Boxed Warning.

About PharmaEssentia

PharmaEssentia USA Corporation, located in Burlington, Massachusetts, is a subsidiary of PharmaEssentia Corporation (TWSE: 6446). PharmaEssentia Corporation, headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan.

For more information about PharmaEssentia USA, visit the website, LinkedIn or X (formerly Twitter).

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