To find the recommended dose of ropeginterferon alfa-2b in combination with azacitidine in patients with newly diagnosed MDS/AML with TP53 mutations. To learn if the recommended dose of ropeinterferon alfa-2b found in Dose Escalation in combination with azacitidine can help to control the disease.

Start Date27 Nov 2026

Sponsor / Collaborator

PharmaEssentia Corp.

NCT07269470

/ Not yet recruitingPhase 2IIT

Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

The goal of this clinical research study is to find out if treatment with a combination of dasatinib plus ropeginterferon can help to control CML-CP. The safety of this combination will also be studied.

Start Date01 Nov 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT07468916

/ Not yet recruitingPhase 2IIT

Ropeginterferon Alfa-2b for MDS/MPN Overlap Syndromes, Including CMML and MDS/MPN-RS-T

This phase II trial tests the safety, best dose, and effectiveness of ropeginterferon alfa-2b for the treatment of patients with myelodysplastic syndrome/myeloproliferative neoplasm overlap syndromes and chronic myelomonocytic leukemia. Ropeginterferon alfa-2b is a form of interferon. Interferons are a type of signaling protein normally produced by the body as part of the immune response. Interferons interfere with the division of cancer cells and can slow cancer cell growth. Ropeginterferon alfa-2b is a long-acting form of a type of interferon called interferon alfa-2b. In the body, ropeginterferon alfa-2b causes the production of proteins that modulate the immune system and have anticancer effects.

Start Date29 Sep 2026

Sponsor / Collaborator

Jonsson Comprehensive Cancer Center

[+1]

100 Clinical Results associated with Ropeginterferon alfa-2b-NJFT

100 Translational Medicine associated with Ropeginterferon alfa-2b-NJFT

100 Patents (Medical) associated with Ropeginterferon alfa-2b-NJFT

248

Literatures (Medical) associated with Ropeginterferon alfa-2b-NJFT

09 Jun 2026·Blood Advances

Ropeginterferon alfa-2b for prefibrotic myelofibrosis and lower-risk myelofibrosis requiring cytoreduction

Article

Author: Li, Vivian ; Wu, Tony K. Y. ; Gill, Harinder ; Lee, Carmen Y. Y. ; Yim, Rita ; Zhang, Qi ; Chin, Lynn ; Kwong, Yok-Lam ; Lee, Paul ; Au, Lester ; Leung, Garret M. K. ; Chan, Po-Yan

Abstract:

There is currently no consensus on the optimal treatment of early myelofibrosis (MF). Ropeginterferon alfa-2b (ropeg) is a next-generation monopegylated interferon alfa-2b developed specifically to treat myeloproliferative neoplasms. We conducted a phase 2 study in patients with prefibrotic primary MF (pre-PMF) and Dynamic International Prognostic Scoring System low-/intermediate-1–risk fibrotic PMF or secondary MF (SMF) who required cytoreduction. Ongoing treatment with hydroxyurea was substituted with ropeg (week 0, 250 μg; week 2, 350 μg; week 4 onward, 500 μg every 2 weeks). The primary end points were safety and clinicohematologic complete response (CHCR). Seventy-one patients (40 men and 31 women) with a median age of 60 years (range, 31-86) were enrolled and followed up for a median of 119 weeks (range, 10-131). At weeks 24, 48, and 104, CHCR was achieved in 63.8% (pre-PMF, 74%; fibrotic PMF, 20%; fibrotic SMF, 42.9%), 63.5% (pre-PMF, 69.6%; fibrotic PMF, 25%; SMF, 53.9%), and 70% of patients (pre-PMF, 78.4%; fibrotic PMF, 33.3%; SMF, 50%), respectively. Thrombo-hemorrhagic events were not observed after stopping hydroxyurea. At weeks 24, 48, and 104, reduction in JAK2V617F variant allele frequency (VAF) was observed in 53.1%, 70%, and 67.6% of patients, and reduction in CALR mutant VAF was observed in 52.6%, 42.9%, and 40% of patients, respectively. In 50 evaluable cases at week 104, 13 patients (26%) had reduced bone marrow reticulin fibrosis. There were 3 treatment discontinuations (4.2%) due to adverse events. In conclusion, ropeg was safe and induced CHCR associated with significant molecular responses in patients with early MF. This trial was registered at www.clinicaltrials.gov as NCT04988815.

07 Jun 2026·Leukemia & Lymphoma

Long-term outcomes of ropeginterferon alfa-2b-njft in polycythemia vera: a review of safety, efficacy, and potential disease modification

Review

Author: Reeves, Brandi ; Abu-Zeinah, Ghaith

Polycythemia vera (PV) is a chronic myeloproliferative neoplasm characterized by erythrocytosis, thrombotic risk, and possible progression to aggressive myeloid neoplasms. Optimal management should achieve durable hematologic response, tolerability, and potential for long-term disease modification. Interferon alpha (IFN-α) is unique among current PV treatments for its disease-modifying potential; however, long-term tolerability concerns remain. Ropeginterferon alfa-2b-njft (ropeg), a novel monopegylated IFN-α, is the only IFN-α approved in the US for PV treatment. Phase III data from PROUD-PV (NCT01949805; EudraCT, 2012-005259-18) and its phase IIIb extension, CONTINUATION-PV (NCT02218047; EudraCT, 2014-001357-17), demonstrate that ropeg, compared with hydroxyurea, achieves hematologic response more slowly but provides greater, more durable responses after ∼18 months, underscoring the importance of long-term adherence. Early adverse events can challenge adherence, emphasizing the need for proactive symptom management. This review offers evidence- and experience-based perspectives on long-term ropeg treatment and adverse event management to support adherence and maximize therapeutic benefit in PV.

01 Jun 2026·LEUKEMIA

A paradigm shift in the treatment of patients with polycythemia vera. The initial early use of recombinant interferon-alpha

Review

Author: Hasselbalch, Hans Carl ; Silver, Richard T

During the past 35 years, single-arm studies documented the efficacy and safety of recombinant interferon alpha (rIFNα) for treating polycythemia vera (PV). In some patients, 2-5 years of disease-modifying treatment resulted in symptom relief, regression of splenomegaly, normalization of abnormal blood counts and marrow morphology, and sustained JAK2V617F molecular remission. The PROUD-CONTI study showed the superiority of rIFNα compared to hydroxyurea (HU), which led to the European Medicines Agency approval in 2019 of ropeginterferon alpha-2b ("ropegIFN") for ELN-defined high-risk PV patients. In 2021, the Food and Drug Administration (USA) gave unrestricted approval, except for pregnant PV patients. The Low-PV randomized trial established the superiority of ropegIFN compared to phlebotomy-only (PHLEB-O) in ELN-defined low-risk patients. Nevertheless, worldwide, HU remains the cytoreductive drug most often used; maintenance PHLEB-O is still endorsed as maintenance therapy by some hematologists. The National Comprehensive Cancer Network (NCCN, USA) approved ropegIFN as a II-A recommendation for ELN-defined low and high-risk disease; the ELN suggested criteria for using rIFNα in low-risk patients if certain issues developed after PHLEB-O, including more symptoms, progressive splenomegaly, significant leukocytosis, thrombocytosis, or inadequate hematocrit control. These issues are important because even low-risk patients are at increased thrombotic risk, estimated at 2 to 3 times that of the general population. Moreover, as PV progresses, the development of myelofibrosis is the leading cause of morbidity, perhaps abetted by PHLEB-O. Here, we review recent progress in the treatment of PV with rIFNα and discuss our rationales and perspectives for, and the endorsement of the initial treatment with rIFNα of both low and high-risk PV patients, unless a contraindication exists to its use.

News (Medical) associated with Ropeginterferon alfa-2b-NJFT

06 Jul 2026

·www.businesswire.com

PharmaEssentia Announces Health Canada Approval of BESREMi® (ropeginterferon alfa-2b) for Polycythemia Vera (PV)

BURLINGTON, Mass.--(BUSINESS WIRE)--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 that its wholly owned subsidiary, FORUS Therapeutics Inc, has received a Notice of Compliance (NOC) authorizing BESREMi® (ropeginterferon alfa-2b) for the treatment of adults with polycythemia vera (PV). BESREMi® is expected to become commercially available in Canada in the coming weeks. PV is a rare, chronic blood cancer characterized by overproduction of red blood cells, which increases blood viscosity and can lead to serious complications, including thrombosis, stroke, myocardial infarction, and progression to myelofibrosis or acute myeloid leukemia. “We are very pleased that Health Canada has approved BESREMi® for the treatment of adults with PV,” said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer of PharmaEssentia. “BESREMi® is a next-generation interferon demonstrated to provide durable hematologic and molecular responses, reduced symptom burden, and a favorable safety and tolerability profile. We look forward to working closely with Canadian hematologists and other key stakeholders to make BESREMi® available to patients living with PV across Canada.” “PV is a chronic myeloproliferative neoplasm that requires long-term management to reduce the risk of complications and control symptoms. The approval of BESREMi® in Canada is an important and welcome development for patients living with PV and for the physicians who care for them,” said Shireen Sirhan, M.D., President, Canadian Myeloproliferative Neoplasms Group; Vice-President (Research), Quebec Research Group for Chronic Myeloid Leukemia and Myeloproliferative Neoplasms (GQR-LMC-NMP); Hematologist, Jewish General Hospital, McGill University Montreal. “The availability of an interferon therapy specifically approved for PV has been long anticipated within the Canadian MPN community and represents a meaningful expansion of the treatment options available to patients. This approval reflects continued progress in the field and supports a more individualized approach to the management of PV." About PharmaEssentia PharmaEssentia Corporation (TWSE: 6446), 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 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 Corp visit the website, LinkedIn or X (formerly Twitter). About Polycythemia Vera (PV) Polycythemia vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2. About BESREMi® (ropeginterferon alfa-2b-njft) Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi® for the treatment of adults with polycythemia vera (PV). The Company is seeking a ropeginterferon alfa-2b-njft label expansion to include ET and has submitted an sBLA with the U.S. FDA. 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), the Pharmaceuticals and Medical Devices Agency in Japan (2023), and Health Canada (2026). The product was developed by PharmaEssentia. 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 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 Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy: Depression and Suicide: Monitor closely for symptoms and need for treatment. Endocrine Toxicity: Discontinue if endocrine disorders occur that cannot be medically managed. Cardiovascular Toxicity: Avoid use in patients with severe, acute or unstable cardiovascular disease. Monitor patients with history of cardiovascular disorders more frequently. Decreased Peripheral Blood Counts: Perform blood counts at baseline, every 2 weeks during titration, and at least every 3-6 months during maintenance treatment. Hypersensitivity Reactions: Stop treatment and immediately manage reaction. Pancreatitis: Consider discontinuation if confirmed pancreatitis Colitis: Discontinue if signs or symptoms of colitis Pulmonary Toxicity: Discontinue if pulmonary infiltrates or pulmonary function impairment Ophthalmologic Toxicity: Advise patients to have eye examinations before and during treatment. Evaluate eye symptoms promptly and discontinue if new or worsening eye disorders. Hyperlipidemia: Monitor serum triglycerides before BESREMi® treatment and intermittently during therapy and manage when elevated. Hepatotoxicity: Monitor liver enzymes and hepatic function at baseline and during treatment. Reduce dose or discontinue depending on severity. Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Discontinue if severe renal impairment develops. Dental and Periodontal Toxicity: Advise patients on good oral hygiene and to have regular dental examinations. Dermatologic Toxicity: Consider discontinuing if clinically significant dermatologic toxicity. Driving and Operating Machinery: Advise patients to avoid driving or using machinery if they experience dizziness, somnolence, or hallucination. Please see full Prescribing Information, including Boxed Warning.

Drug ApprovalOrphan Drug

26 Jun 2026

·www.biospace.com

PharmaEssentia Announces FDA Approval and U.S. Launch of BESREMi Pen™ (ropeginterferon alfa-2b-njft) for Polycythemia Vera

New pre-filled pen device enhances patient experience by simplifying self-administration BURLINGTON, Mass.--(BUSINESS WIRE)--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 the U.S. Food and Drug Administration (FDA) approval and launch of the BESREMi Pen™ (ropeginterferon alfa-2b-njft) device for adult patients with polycythemia vera (PV). The device offers a more convenient self-administration option than the currently available pre-filled syringe. The BESREMi Pen™ is expected to become commercially available in the U.S. in the coming weeks. “The U.S. approval of the BESREMi Pen™ is a significant milestone both for our company, as well as the patients we serve,” said Samuel Lin, Head of Global Operations, PharmaEssentia. “With this new device, we’re empowering more people living with PV to manage their condition with greater ease and confidence. It reflects our continued commitment to delivering not only innovative therapeutics, but also smarter, more intuitive ways to support long-term care.” “I’m very excited to see the FDA approval of the BESREMi Pen™ as a new option for patients,” said Dr. John Mascarenhas, Director of the Center of Excellence for Blood Cancers and Myeloid Disorders at Mount Sinai in New York City. “Treatment consistency is critical for managing PV, and this device has the potential to make a meaningful positive impact on patients’ lives by simplifying self-administration and supporting better adherence.” 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) . About Polycythemia Vera (PV) Polycythemia vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2. About BESREMi® (ropeginterferon alfa-2b-njft) Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi® for the treatment of adults with polycythemia vera (PV). The Company plans to seek a ropeginterferon alfa-2b-njft label expansion to include ET and has submitted a sBLA with the U.S. FDA. 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. 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 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 Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy: Depression and Suicide: Monitor closely for symptoms and need for treatment. Endocrine Toxicity: Discontinue if endocrine disorders occur that cannot be medically managed. Cardiovascular Toxicity: Avoid use in patients with severe, acute or unstable cardiovascular disease. Monitor patients with history of cardiovascular disorders more frequently. Decreased Peripheral Blood Counts: Perform blood counts at baseline, every 2 weeks during titration, and at least every 3-6 months during maintenance treatment. Hypersensitivity Reactions: Stop treatment and immediately manage reaction. Pancreatitis: Consider discontinuation if confirmed pancreatitis Colitis: Discontinue if signs or symptoms of colitis Pulmonary Toxicity: Discontinue if pulmonary infiltrates or pulmonary function impairment Ophthalmologic Toxicity: Advise patients to have eye examinations before and during treatment. Evaluate eye symptoms promptly and discontinue if new or worsening eye disorders. Hyperlipidemia: Monitor serum triglycerides before BESREMi® treatment and intermittently during therapy and manage when elevated. Hepatotoxicity: Monitor liver enzymes and hepatic function at baseline and during treatment. Reduce dose or discontinue depending on severity. Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Discontinue if severe renal impairment develops. Dental and Periodontal Toxicity: Advise patients on good oral hygiene and to have regular dental examinations. Dermatologic Toxicity: Consider discontinuing if clinically significant dermatologic toxicity. Driving and Operating Machinery: Advise patients to avoid driving or using machinery if they experience dizziness, somnolence, or hallucination. Please see full Prescribing Information , including Boxed Warning. Contacts Media Muriel Huang Director, Investor Relations and Corporate Communication muriel_huang@pharmaessentia.com

Drug ApprovalOrphan Drug

11 Jun 2026

·www.biospace.com

PharmaEssentia Expands North American Commercial Footprint with Acquisition of Canadian Partner FORUS Therapeutics

Acquisition deepens PharmaEssentia's presence in the Canadian hematology-oncology MPN market to accelerate BESREMi ® (ropeginterferon alfa-2b) commercialization BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical company headquartered in Taiwan, today announced the acquisition of FORUS Therapeutics Inc. ("FORUS"), a Canadian specialty pharmaceutical company, in a transaction valued at US$36.5 million. The acquisition represents an important component of PharmaEssentia's North American commercial strategy and marks a significant milestone in the company's global expansion. PharmaEssentia entered into a commercial licensing agreement with FORUS for BESREMi ® in Canada in 2024. FORUS has deep roots in the Canadian hematology and oncology space, with an experienced team and established regulatory, medical, commercial, and market-access infrastructure. FORUS submitted a New Drug Submission to Health Canada for ropeginterferon alfa-2b for polycythemia vera (PV) in July 2025, with regulatory approval expected in Q3 2026. A submission for the additional indication of essential thrombocythemia (ET) is being prepared, further expanding the market opportunity. By acquiring 100% of FORUS, PharmaEssentia will fully integrate Canadian regulatory and medical affairs, marketing, and commercial channel resources — consolidating competitive advantages for BESREMi ® and future products in the market. This opportunity also allows PharmaEssentia to explore potential important market synergies and opportunities in Canada with FORUS’s other partner, Karyopharm and its lead asset, XPOVIO. "This acquisition is the culmination of a strong and proven partnership with the FORUS team," said Dr. Ko-Chung Lin, Founder and Chief Executive Officer of PharmaEssentia. "By bringing their regulatory expertise, market relationships, and medical/commercial capabilities fully in-house, we are best positioned to accelerate BESREMi ® 's availability to patients with MPN across Canada, and to build a durable North American platform for our growing portfolio." The FORUS team brings more than 25 years of hematology and oncology commercialization experience, with backgrounds at Celgene, Roche, Pfizer, and other leading global pharmaceutical companies. Collectively, the team has launched more than 10 products, generating over C$2 billion in cumulative sales. FORUS CEO Kevin Leshuk spent 13 years at Celgene, where he established the Canadian subsidiary and built a leading hematology-oncology team, successfully launching multiple critical oncology therapies. "Joining PharmaEssentia marks an exciting new chapter and opportunity for the FORUS team," said Kevin Leshuk, CEO of FORUS Therapeutics. "Our respective organizations share a deep commitment to the hematology community and to bringing ropeginterferon alfa-2b to the Canadian patients who need it. This acquisition now provides the local team the opportunity to build upon the existing experience with XPOVIO and leverage combined capabilities, infrastructure, and expertise as we build a leading MPN and hematology-oncology franchise in Canada." PharmaEssentia remains committed to advancing innovation, building strategic international partnerships, and expanding access to transformative therapies for patients worldwide. 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 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) . About BESREMi ® (ropeginterferon alfa-2b-njft) Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi ® for the treatment of adults with polycythemia vera (PV). The Company plans to seek a ropeginterferon alfa-2b-njft label expansion to include ET and has submitted a sBLA with the U.S. FDA. 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. 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 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 Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy: Depression and Suicide: Monitor closely for symptoms and need for treatment. Endocrine Toxicity: Discontinue if endocrine disorders occur that cannot be medically managed. Cardiovascular Toxicity: Avoid use in patients with severe, acute or unstable cardiovascular disease. Monitor patients with history of cardiovascular disorders more frequently. Decreased Peripheral Blood Counts: Perform blood counts at baseline, every 2 weeks during titration, and at least every 3-6 months during maintenance treatment. Hypersensitivity Reactions: Stop treatment and immediately manage reaction. Pancreatitis: Consider discontinuation if confirmed pancreatitis Colitis: Discontinue if signs or symptoms of colitis Pulmonary Toxicity: Discontinue if pulmonary infiltrates or pulmonary function impairment Ophthalmologic Toxicity: Advise patients to have eye examinations before and during treatment. Evaluate eye symptoms promptly and discontinue if new or worsening eye disorders. Hyperlipidemia: Monitor serum triglycerides before BESREMi ® treatment and intermittently during therapy and manage when elevated. Hepatotoxicity: Monitor liver enzymes and hepatic function at baseline and during treatment. Reduce dose or discontinue depending on severity. Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Discontinue if severe renal impairment develops. Dental and Periodontal Toxicity: Advise patients on good oral hygiene and to have regular dental examinations. Dermatologic Toxicity: Consider discontinuing if clinically significant dermatologic toxicity. Driving and Operating Machinery: Advise patients to avoid driving or using machinery if they experience dizziness, somnolence, or hallucination. Please see full Prescribing Information , including Boxed Warning. Contacts Media Muriel Huang Director, Investor Relations and Corporate Communication muriel_huang@pharmaessentia.com

Drug ApprovalLicense out/inAcquisitionOrphan Drug

100 Deals associated with Ropeginterferon alfa-2b-NJFT

External Link

KEGG	Wiki	ATC	Drug Bank
D11027	Ropeginterferon alfa-2b-NJFT	L03AB15	DB15119

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Polycythemia Vera	European Union	AOP Orphan Pharmaceuticals GmbH	15 Feb 2019
Polycythemia Vera	Iceland	AOP Orphan Pharmaceuticals GmbH	15 Feb 2019
Polycythemia Vera	Liechtenstein	AOP Orphan Pharmaceuticals GmbH	15 Feb 2019
Polycythemia Vera	Norway	AOP Orphan Pharmaceuticals GmbH	15 Feb 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Primary Myelofibrosis	Phase 3	United States	PharmaEssentia Corp.	18 Jul 2025
Primary Myelofibrosis	Phase 3	Japan	PharmaEssentia Corp.	18 Jul 2025
Thrombocythemia, Essential	Phase 3	United States	PharmaEssentia Corp.	25 Aug 2020
Thrombocythemia, Essential	Phase 3	China	PharmaEssentia Corp.	25 Aug 2020
Thrombocythemia, Essential	Phase 3	Japan	PharmaEssentia Corp.	25 Aug 2020
Thrombocythemia, Essential	Phase 3	Canada	PharmaEssentia Corp.	25 Aug 2020
Thrombocythemia, Essential	Phase 3	Hong Kong	PharmaEssentia Corp.	25 Aug 2020
Thrombocythemia, Essential	Phase 3	Singapore	PharmaEssentia Corp.	25 Aug 2020
Thrombocythemia, Essential	Phase 3	South Korea	PharmaEssentia Corp.	25 Aug 2020
Thrombocythemia, Essential	Phase 3	Taiwan Province	PharmaEssentia Corp.	25 Aug 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2026	Not Applicable	Polycythemia Vera	18	Ropeginterferon alfa-2b with HIDAT	txbzfrwdsd(bblzydvnrs) = wgvoudnpcx jzanzfdaxf (derlkxhqys ) View more	Positive	29 May 2026
				Ropeginterferon alfa-2b with low-dose regimens	txbzfrwdsd(bblzydvnrs) = zswmpckyvr jzanzfdaxf (derlkxhqys ) View more
EHA2026	Not Applicable	Polycythemia Vera	99	Ropeginterferon alfa-2b	srakgqflcy(qixomblkjd) = xcdikdzuis ljskwmqiek (qrqnghmrml ) View more	Positive	12 May 2026
NCT04285086 (SURPASS-ET, EHA2026)	Phase 3	Thrombocythemia, Essential	174	P1101	arzvnbviix(llvxpfthnl) = yottcuquss osnuhigsnf (lbdbmmwhcy, 66.4 - 84.4) View more	Positive	12 May 2026
				Anagrelide	arzvnbviix(llvxpfthnl) = myevyuabtt osnuhigsnf (lbdbmmwhcy, 30.6 - 55.0) View more
EHA2026	Not Applicable	Myeloproliferative Disorders	206	ropeginterferon alfa-2b	hwpsnekqdf(cjzgnesekr) = Adverse event-related discontinuations included hepatic dysfunction, neuropathy, migraine, ocular symptoms, and vascular events, each occurring in ≤ 2 patients. cyaevuvxmr (neeyjlklme ) View more	Positive	12 May 2026
				ropeginterferon alfa-2b (switch cohort)
NCT06514807 (ROP-ET, EHA2026)	Phase 3	Thrombocythemia, Essential	132	Ropeginterferon alfa-2b	kzqojkquuu(qnigvqcfaq) = judyypocat wialhkxapd (bxretbzoxk ) View more	Positive	12 May 2026
				Ropeginterferon alfa-2b (high‐risk)	bexovcqsam(wlduxmnbso) = xavesukbtv htqdsqtrwu (xgdwkbabrl, 42.3 - 69.7)
NCT06506084 (EHA2026)	Not Applicable	Polycythemia Vera	262	ROPEGINTERFERON ALFA-2B (HU-intolerant patients)	bnppkboxye(xwcudtijzc) = cfgtyeywaa wepaclpfnf (kcanzwabac ) View more	Positive	12 May 2026
				ROPEGINTERFERON ALFA-2B (with a history of skin cancer)	bnppkboxye(xwcudtijzc) = cuadxktrxa wepaclpfnf (kcanzwabac ) View more
SURPASS-ET (EHA2026)	Phase 3	Thrombocythemia, Essential	137	Ropeginterferon alfa-2b (SURPASS-ET study)	ioorqrynbd(lpdhswplqc) = fzgimgsycm qbrfvqlnue (mwgoqavqfl ) View more	Positive	12 May 2026
				Anagrelide (SURPASS-ET study)	uzwlpxsjlg(cywhggkrmx) = jwzorxzppy tacsnhjtnw (lhfkmbcybk ) View more
EHA2026	Not Applicable	Polycythemia Vera JAK2V617F	15	Ropeginterferone alfa-2b (JAK2V617F positive + Polycythemia Vera + HU-intolerant)	bksdxcwiwz(egyloplled) = ptoyfavnch ouhaxymhxw (nlehjacqhi ) View more	Positive	12 May 2026
NCT06002490 (A23-301, Company_Website) Manual	Phase 3	Polycythemia Vera	-	BESREMi	lqwhfvhycn(vifrgmzjmx) = ftomruwwoq rhjlkfsapx (uzycxmxdzm )	Positive	02 Mar 2026
NCT05482971 (EXCEED-ET, Company_Website) Manual	Phase 2	Thrombocythemia, Essential	91	Ropeginterferon alfa-2b-njft (Treatment-naïve patients)	gldwpfqpbv(yxyrzwcsrp) = olkqngvwyy fmuabpjdbe (sgynfcmxvm ) View more	Positive	12 Jan 2026
				Ropeginterferon alfa-2b-njft (Hydroxyurea-experienced patients)	gldwpfqpbv(yxyrzwcsrp) = cbsbbzhbep fmuabpjdbe (sgynfcmxvm ) View more

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