{"id":30921,"date":"2026-07-06T17:00:00","date_gmt":"2026-07-06T15:00:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=f11779338ac476992a83857310413d44"},"modified":"2026-07-06T17:00:00","modified_gmt":"2026-07-06T15:00:00","slug":"pharmaessentia-announces-health-canada-approval-of-besremi-ropeginterferon-alfa-2b-for-polycythemia-vera-pv","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=30921","title":{"rendered":"PharmaEssentia Announces Health Canada Approval of BESREMi\u00ae (ropeginterferon alfa-2b) for Polycythemia Vera (PV)"},"content":{"rendered":"

\nBESREMi<\/i>\u00ae is a next-generation interferon approved for the treatment of adults with PV<\/i><\/p>

BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia Corporation<\/a> (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\u00ae (ropeginterferon alfa-2b) for the treatment of adults with polycythemia vera (PV). BESREMi\u00ae is expected to become commercially available in Canada in the coming weeks.<\/p><\/a><\/a>

\nPV 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.<\/p>

\n\u201cWe are very pleased that Health Canada has approved BESREMi\u00ae for the treatment of adults with PV,\u201d said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer of PharmaEssentia. \u201cBESREMi\u00ae 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\u00ae available to patients living with PV across Canada.\u201d<\/p>

\n\u201cPV is a chronic myeloproliferative neoplasm that requires long-term management to reduce the risk of complications and control symptoms. The approval of BESREMi\u00ae in Canada is an important and welcome development for patients living with PV and for the physicians who care for them,\u201d 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. \u201cThe 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.\"<\/p>

\nAbout PharmaEssentia\n<\/b>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<\/a>, LinkedIn<\/a> or X (formerly Twitter)<\/a>.<\/p>

\nAbout Polycythemia Vera (PV)\n<\/b>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.<\/p>

\nAbout BESREMi\u00ae (ropeginterferon alfa-2b-njft)\n<\/b>Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi\u00ae<\/sup> 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.<\/p>

\nBESREMi\u00ae<\/sup> 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).<\/p>

\nThe product was developed by PharmaEssentia. PharmaEssentia retains full global intellectual property rights across all indications.<\/p>

\nINDICATION\nBESREMi\u00ae is indicated for the treatment of adults with polycythemia vera.<\/p>

\nIMPORTANT SAFETY INFORMATION\nWARNING: RISK OF SERIOUS DISORDERS\nInterferon 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.<\/p>

\nCONTRAINDICATIONS\nExistence of or history of severe depression, suicidal ideation, or suicide attempt\nHypersensitivity to interferons or any inactive ingredients\nModerate or severe hepatic impairment\nHistory or presence of active serious or untreated autoimmune disease\nHistory of transplantation and receiving immunosuppressant agents\nWARNINGS AND PRECAUTIONS\nPatients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy:<\/p>