(OAKVILLE, Ontario) July 6, 2026 – FORUS Therapeutics Inc (“FORUS”), a wholly owned subsidiary of PharmaEssentia Corp, is pleased to announce that it 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.
Polycythemia vera 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 polycythemia vera,” said Ko-Chung Lin, Ph.D., Founder and CEO 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.
“Polycythemia vera 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 Dr. Shireen Sirhan, 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 (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 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 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. PharmaEssentia and BESREMI are trademarks or registered trademarks of PharmaEssentia Corporation and are used by FORUS under license.
INDICATION
BESREMI® is indicated for the treatment of adults with polycythemia vera.
For Further Information and Media Inquiries: Kevin Leshuk, General Manager, FORUS Therapeutics Inc. (media@forustherapeutics.com)