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

BESREMi® is a next-generation interferon approved for the treatment of adults with PV

 

BURLINGTON, Mass, July 6, 2026 – 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.

 

Contacts

Media
Muriel Huang
Director, Investor Relations and Corporate Communication
muriel_huang@pharmaessentia.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, June 26, 2026 – 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

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

PharmaEssentia Announces Taiwan Approval of BESREMi® for Essential Thrombocythemia, Marking First Global Approval in ET

First global approval of BESREMi® in essential thrombocythemia supports continued expansion of the PharmaEssentia MPN franchise; U.S. PDUFA date remains on track for August 30, 2026

BESREMi® becomes first new approved therapy for ET in nearly 30 years

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 that the Taiwan’s Ministry of Health and Welfare (MOHW) has approved ropeginterferon alfa-2b-njft (BESREMi®) for the treatment of adult patients with essential thrombocythemia (ET). BESREMi® is the first new therapy approved for ET in nearly 30 years.

The approval represents the first global regulatory approval of BESREMi® in ET and marks an important milestone in the strategy to expand BESREMi across myeloproliferative neoplasms (MPNs). With the first global approval in ET now secured in Taiwan, BESREMi® is well-positioned to address a significant global market opportunity, including in the United States, where the U.S. Food and Drug Administration (FDA) is currently reviewing a supplemental Biologics License Application (sBLA) for ET with a Prescription Drug User Fee Act (PDUFA) target action date of August 30, 2026.

ET is a chronic MPN characterized by excessive platelet production and increased risk of thrombosis, hemorrhage. Based on data from the Phase 3 SURPASS-ET and Phase 2 EXCEED-ET studies, PharmaEssentia believes BESREMi® has the potential to address a broad ET patient population regardless of underlying disease subtype, supporting a significant global expansion opportunity for the BESREMi® franchise.

“This first global approval of BESREMi® in ET represents an important strategic milestone for PharmaEssentia and further strengthens the Company’s leadership position in myeloproliferative neoplasms,” said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer of PharmaEssentia. “We believe ET represents a major long-term growth opportunity for BESREMi® and has the potential to significantly expand the reach of the Company’s hematology franchise globally. This approval also advances our broader strategy to expand the global BESREMi® franchise as we continue preparations for a potential U.S. approval and commercial launch in ET later this year.”

Dr. Lin continued, “Data generated across the Phase 3 SURPASS-ET study and the Phase 2b EXCEED-ET trial demonstrated the potential of ropeginterferon alfa-2b to achieve durable hematologic and molecular responses in ET patients, supporting the potential for durable hematologic and molecular responses consistent with disease-modifying activity in ET. We believe the differentiated profile and dosing schedule of BESREMi® position BESREMi® as a differentiated treatment option for a broad range of ET patients.”

The TFDA approval was supported by data from the global Phase 3 SURPASS-ET study, which evaluated ropeginterferon alfa-2b in high-risk ET patients resistant or intolerant to hydroxyurea. Specifically, in the global Phase 3 trial SURPASS-ET, BESREMi® demonstrated a superior durable clinical response rate compared to anagrelide (42.9% vs. 6.0%; p=0.0001). Across clinical studies, BESREMi® demonstrated clinically meaningful hematologic responses, molecular responses, and a manageable safety profile.

In addition to the ongoing FDA review of the ET sBLA, ropeginterferon alfa-2b has been added to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for the treatment of ET, further supporting increasing adoption of interferon-based treatment approaches in ET and other MPNs.

PharmaEssentia is the inventor and owner of BESREMi® (ropeginterferon alfa-2b-njft) and maintains intellectual property rights for the product across all indications.

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 is seeking 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 Contact
Muriel Huang
Director, Investor Relations and Corporate Communication
muriel_huang@pharmaessentia.com

PharmaEssentia Appoints Eric Vogel as U.S. Head of Commercialization Ahead of Potential Launch of BESREMi® in Essential Thrombocythemia

Former Incyte commercial executive brings deep hematology and MPN market experience

BURLINGTON, Mass.–(BUSINESS WIRE)–PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical company headquartered in Taiwan, announced that Eric Vogel has joined the company as U.S. Head of Commercialization. A seasoned commercial leader with more than 20 years of experience in oncology and hematology, Vogel will support Samuel Lin, Head of Global Operations, in driving the commercial growth of BESREMi® (ropeginterferon alfa-2b-njft) for approved uses across global markets.

Vogel joins PharmaEssentia from Incyte Corporation, where he most recently served as Group Vice President of Sales and Marketing, overseeing a broad oncology and hematology portfolio, including commercial activities within the myeloproliferative neoplasm (MPN) market. During his tenure at Incyte, he built and led a high-performing sales organization and played a key role in driving significant commercial growth and consistently exceeding market expectations.

“We are very pleased to welcome Eric to PharmaEssentia,” said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer of PharmaEssentia. “His deep expertise in hematology and the MPN market, combined with his strong track record of commercial execution, will be very valuable as we continue to advance the global growth of BESREMi® and prepare for the potential U.S. launch in ET.”

“The clinical results BESREMi® has demonstrated in Polycythemia Vera is truly impressive, and support what I believe is a highly differentiated opportunity in the MPN market,” said Vogel. “I look forward to working with the PharmaEssentia team to support the potential expansion of BESREMi® and help bring this important therapy to more patients worldwide.”

Prior to Incyte, Vogel held a series of senior commercial leadership roles at AstraZeneca Pharmaceuticals, where he led oncology and specialty care sales forces and was responsible for several successful product launches, including AstraZeneca’s first orphan drug. He holds an M.B.A. in Strategic Leadership from the University of Delaware and a B.S. in Commerce and Engineering Sciences from Drexel University.

As PharmaEssentia continues to advance its global ET regulatory strategy, including ongoing submissions in the U.S., Japan, China, and South Korea, Vogel’s appointment further strengthens the Company’s commercial infrastructure ahead of the U.S. Food and Drug Administration’s Prescription Drug User Fee Act (PDUFA) target action date for BESREMi® in ET on August 30, 2026.

PharmaEssentia also announced that the application period for the PharmaEssentia Innovation Award is entering its final week. The award, which includes a top potential investment or award of $100,000, is open to early-stage biotech teams advancing innovative research in hematology, oncology, immunology, and rare diseases. Finalists will present in Tokyo in June 2026, with the winner to be announced at BIO Asia-Taiwan in July 2026. Satish Tadikonda of Harvard Business School, a leading voice on life sciences investment and entrepreneurship, is serving as a judge for the award. The program is sponsored by PharmaEssentia, organized in partnership with TECH Tokyo, and supported by Global Bio & Investment Monthly as media partner. Teams working in therapeutic drug development, AI-enabled drug discovery, or cell therapy technologies are encouraged to apply before the deadline.

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

PharmaEssentia to Present New Clinical Data Supporting the Use of Ropeginterferon Alfa-2b in Essential Thrombocythemia at ASCO and EHA 2026

Two-year and post-hoc SURPASS-ET analyses highlight the impact of treatment timing, with durable responses and improved progression-free survival supporting consideration of earlier ropeginterferon alfa-2b use in high-risk ET following hydroxyurea intolerance or resistance

First presentation of integrated SURPASS-ET and EXCEED-ET data highlights consistent responses across treatment lines, mutation subtypes, and patient populations

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 five upcoming presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA) 2026 Congress. The ASCO annual meeting will be held May 29-June 2 in Chicago, and the EHA2026 Congress will be held June 11-14 in Stockholm, Sweden.

PharmaEssentia will present new analyses from the Phase 3 SURPASS-ET study (NCT04285086) of ropeginterferon alfa-2b in patients with essential thrombocythemia (ET), including two-year outcomes comparing early versus delayed initiation (continuous treatment from baseline vs. initiation following prior anagrelide therapy) and post-hoc analyses of patients who transitioned from anagrelide. Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi® for the treatment of adults with polycythemia vera (PV). The use of ropeginterferon alfa-2b-njft for ET is currently still investigational, but it is currently under review by FDA with a PDUFA goal date of August 30, 2026.

Findings from SURPASS-ET demonstrate sustained hematologic control and progressive molecular improvement with longer interferon exposure, with deeper molecular responses and improved long-term disease control observed with earlier initiation. Patients who transitioned from anagrelide showed improved hematologic parameters over 12 weeks, supporting the feasibility of treatment transition. Importantly, estimated progression-free survival (PFS) at 24 months was 76.9% in patients who received ropeginterferon alfa-2b from baseline compared to 43.1% in those with delayed initiation. Together, these data support consideration of earlier ropeginterferon alfa-2b use in high-risk ET following hydroxyurea intolerance or resistance.

PharmaEssentia will also present an integrated analysis of the SURPASS-ET and Phase 2b EXCEED-ET (NCT05482971) trials. The analysis includes 182 patients across both studies and evaluates the consistency of clinical benefit across treatment lines, including treatment-naïve and previously treated populations, as well as across molecular subtypes and ethnicities. Results demonstrated clinically meaningful hematologic and molecular responses in both treatment-naïve and pretreated patients. Efficacy was consistent across driver mutation subtypes, and the presence of additional non-driver mutations did not adversely impact outcomes.

“These findings represent an important step forward in understanding the potential use of interferon-based approaches in essential thrombocythemia,” said Ruben Mesa, M.D., co-principal investigator, presenting author, and President of Advocate Health Cancer National Service Line. “Together, these data continue to build on the growing body of evidence supporting the use of ropeginterferon alfa-2b in ET and reinforce its potential role as a meaningful treatment option for patients.”

In addition, PharmaEssentia will present real-world data evaluating the association between neutrophil-to-lymphocyte ratio (NLR) and thrombotic risk in 11,809 U.S. veterans with PV. An online-only abstract will also report findings from a meta-analysis evaluating dosing strategies for ropeginterferon alfa-2b in PV, suggesting that a higher initial dose with accelerated titration (HIDAT) may lead to improved early hematologic and molecular response rates compared to lower-dose currently approved regimens.

ASCO
Poster Presentations

Title: Integrated Analysis of the Ropeginterferon alfa-2b Clinical Program in Essential Thrombocythemia to Demonstrate Molecular and Hematologic Responses with Safety Profile Across Treatment Lines, Ethnicities, and Driver Mutation Types
Abstract Number: 6576
Poster: 369
Presenter: Ruben Mesa, M.D.
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date: June 1st
Time: 9-12 pm CDT

Title: Association of neutrophil‑to‑lymphocyte ratio and thrombotic events in US Veterans with Polycythemia vera
Abstract Number: 6578
Poster: 371
Presenter: Ying Wang, PhD
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date: June 1st
Time: 9-12 pm CDT

Published Abstract

Title: Effect ofHigher Initial Dose and Accelerated Titration of Ropeginterferon Alfa-2b on Early Hematologic and Molecular Responses in Polycythemia Vera: A Meta-Analysis
Abstract Number: e18592

EHA
Oral Presentation
Title: Early versus Delayed Initiation of Ropeginterferon Alfa-2b in High-Risk Essential Thrombocythaemia: Two-Year Results from the Phase 3 SURPASS-ET Study
Abstract Number: S219
Presenter: Harry Gill, M.D.
Session: Myeloproliferative neoplasms – Clinical
Date: June 13th
Time: 5:15 – 6:30 pm CEST

Poster Presentations

Title: Ropeginterferon alfa-2b Demonstrates Molecular and Hematologic Responses with a Favorable Safety Profile in Essential Thrombocythemia
Abstract Number: PS1986
Presenter: Harry Gill, M.D.
Session: Myeloproliferative neoplasms – Clinical
Date: June 13th
Time: 6:45 – 7:45 pm CEST

Title: Hematologic Control and Improved Safety Following Switch from Anagrelide to Ropeginterferon Alfa-2b in Patients with Essential Thrombocythemia: 12-Week Pre-/Post-Switch Analysis from the SURPASS-ET study
Abstract Number: PF912
Presenter: Lucia Masarova, M.D.
Session: Myeloproliferative neoplasms – Clinical
Date: June 12th
Time: 6:45 – 7:45 pm CEST

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 and the developer and owner of BESREMi® (ropeginterferon alfa-2b-njft). 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 Essential Thrombocythemia (ET)
Essential thrombocythemia is a rare blood disorder and type of myeloproliferative neoplasm (MPN). It is characterized by the bone marrow overproducing platelets. Patients with ET are at an increased risk of blood clots, abnormal bleeding and enlarged spleens. ET is often caused by genetic mutations such as a JAK2 genetic mutation.

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 Contact
Muriel Huang
Director, Investor Relations and Corporate Communication
muriel_huang@pharmaessentia.com

Taiwan’s Representative to the United States Alexander Tah-ray Yui Visits PharmaEssentia’s Puerto Rico Facility Alongside Puerto Rico Officials

Focused on U.S. Manufacturing: Witnessing the Full Launch of the “Dual Taiwan-U.S. Production Base” Strategy

Pictured from left (third from left): Charles Chi Yu Chou, Director General of the Taipei Economic and Cultural Office (TECO) Miami; Taiwan’s Representative to the United States Alexander Tah-ray Yui and Mme. Karen Lo; and Sam Lin, Head of Global Operations and General Manager of PharmaEssentia Puerto Rico — joined by members of the PharmaEssentia team and Puerto Rico government officials at the company’s new Puerto Rico facility.

BURLINGTON, Mass.–(BUSINESS WIRE)–PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical company headquartered in Taiwan, announced that Taiwan’s Representative to the United States Alexander Tah-ray Yui and Mme. Karen Lo, accompanied by Charles Chi Yu Chou, Director General of Taipei Economic and Cultural Office (TECO) Miami, and Felipe Tsai, Deputy Director of TECO Miami, visited PharmaEssentia’s Puerto Rico facility on April 20 (Eastern Time). This marks the second high-level visit by a Taiwan government official to PharmaEssentia’s overseas operations — following the May 2023 visit by then-Representative Hsiao Bi-khim (now Vice President of Taiwan) to the company’s U.S. subsidiary in Boston — underscoring the Taiwan government’s strong commitment to supporting the international expansion of Taiwan’s biotechnology industry.

The visit also brought together a distinguished group of Puerto Rico officials, including Bernardo Márquez, Mayor of Toa Baja; James Ramos, Economic Development, Director of Toa Baja; Soraya Morón, Deputy Secretary of Strategic Operations, Department of Economic Development and Commerce (DDEC); and Denisse Rodriguez, Invest Puerto Rico’s Stakeholder Affairs Director. The joint presence of representatives from both the Taiwan and Puerto Rico governments reflects strong bilateral support for PharmaEssentia’s new facility and demonstrates shared confidence in the company’s local investment.

Sam Lin, Head of Global Operations of PharmaEssentia and General Manager of PharmaEssentia Puerto Rico, hosted the delegation on behalf of the company. He presented an overview of PharmaEssentia’s corporate development, recent key milestones, investment progress in Puerto Rico, and future operational strategy. The delegation also toured the facility to gain a firsthand look at the construction progress and future development roadmap.

This year, PharmaEssentia has officially launched the full-scale buildout of its new Puerto Rico facility, actively expanding local production capacity as it advances its “Dual Taiwan-U.S. Production Base” strategy to build a more resilient global supply chain. The new Puerto Rico facility represents a critical milestone in the company’s global manufacturing footprint, laying a key foundation for future operational growth.

The visit further strengthens the ties between Taiwan’s biotechnology industry and Puerto Rico’s government and investment community. PharmaEssentia reaffirmed its commitment to bilateral cooperation, leveraging innovative R&D and international manufacturing to enhance Taiwan’s biotechnology sector on the global stage.

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).

Contacts

Media Contact
Muriel Huang
Director, Investor Relations and Corporate Communication
muriel_huang@pharmaessentia.com

PharmaEssentia Signs Investment Agreement for New Manufacturing Facility in Puerto Rico

A pivotal step in PharmaEssentia’s dual-site U.S.-Taiwan manufacturing strategy, with 2027 operations in sight

BURLINGTON, Mass.–(BUSINESS WIRE)–PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical company headquartered in Taiwan, announced that on Thursday, March 26, it signed an investment agreement for a new manufacturing facility in Toa Baja, Puerto Rico. The signing ceremony marks an important milestone in the company’s strategy to establish a dual-site manufacturing network in Taiwan and the United States, strengthening global supply chain resilience and supporting long-term growth.

The signing ceremony was attended by Puerto Rico Governor Jenniffer González Colón, Secretary of Economic Development and Commerce Sebastián Negrón Reichard, U.S. Department of Commerce Director for Puerto Rico and the U.S. Virgin Islands Jose Burgos, Director General of the Taipei Economic and Cultural Office (TECO) in Miami Chi Yu Chou, Director of Economic Development of the Municipality of Toa Baja James Ramos, and CEO of Invest Puerto Rico Ella Woger-Nieves, among other distinguished officials. Their participation underscores the strong bilateral collaboration between Taiwan and the United States in advancing life sciences manufacturing and innovation.

Chairperson Dr. Ching-Leou Teng opened the ceremony with a clear statement of intent: “This is not just a closing — it is the start of a long-term partnership and a clear demonstration of our commitment to patients.”

“This investment reaffirms Puerto Rico’s position as a reliable and competitive U.S. jurisdiction for advanced biopharmaceutical manufacturing. We continue to attract projects that strengthen our economy, create specialized jobs, and contribute to the resilience of the United States’ supply of critical medicines,” said Governor Jenniffer González Colón.

Director General Chi Yu Chou of TECO Miami stated that PharmaEssentia’s investment in Puerto Rico reflects the strengthening economic ties between Taiwan and the United States. “The company’s dual production strategy embodies the symbiotic partnership between the two sides, as emphasized by Foreign Minister Lin Chia-lung. This project demonstrates the breadth and resilience of Taiwan’s industries, extending beyond AI and semiconductors into biotechnology and healthcare. It also underscores the potential for deeper bilateral economic cooperation and the continued global competitiveness of Taiwanese enterprises in high-value sectors.”

The Puerto Rico facility is designed to the same high-quality standards of PharmaEssentia’s existing manufacturing site in Taichung, Taiwan, while optimizing production efficiency and diversifying manufacturing risk. Personnel from the Puerto Rico facility will complete intensive training at the Taichung site to support knowledge transfer and operational readiness. The company is planning for the facility to begin operations in 2027 and is committed to engaging with regulators to obtain all necessary approvals.

“Expanding manufacturing capacity outside Taiwan is a core strategic priority for PharmaEssentia,” said Dr. Ko-Chung Lin, Founder and Chief Executive Officer. “We are proud to establish U.S.-based manufacturing, with Puerto Rico serving as a key hub to support the U.S. market and our commitment to patients worldwide – including those benefiting from BESREMi® (ropeginterferon alfa-2b-njft).”

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 Contact
Muriel Huang
Director, Investor Relations and Corporate Communication
muriel_huang@pharmaessentia.com

PharmaEssentia Announces Japan Approval of High-Dose Dosing Regimen for BESREMi®

New regimen for ropeginterferon alfa2b-njft enables patients to reach target dose faster, supporting positive clinical outcomes and enabling faster achievement of maintenance dose

BURLINGTON, Mass, Mar. 2, 2026–PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical company headquartered in Taiwan with deep expertise in the development of novel biologics for hematology and oncology, and its Japanese subsidiary today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the inclusion of a high-dose dosing regimen for Ropeginterferon alfa-2b in the product label as an alternative dosing schedule.

Clinical data show that the high-dose regimen shortens the time to reach the target maintenance dose and supports earlier therapeutic benefit. The revision is based on the domestic Phase III A23-301 trial, an open-label, uncontrolled study in Japanese patients with polycythemia vera. Treatment was initiated at 250 mcg and, if tolerated, escalated to 350 mcg at two weeks and 500 mcg at four weeks, followed by subcutaneous administration every two weeks for up to 24 weeks. The Week 24 complete hematologic response rate was 57.1%.

This approval was supported by compelling complete hematologic response (CHR) results achieved with a one-month optimized dosing regimen, enabling patients to reach the target 500 mcg dose significantly faster than in the previously approved bridging study, which required gradual titration over four to four and a half months.

Importantly, the safety profile, including serious adverse events (SAEs), remained consistent with prior experience and comparable across dosing approaches.

By allowing patients to achieve optimal therapeutic dosing more rapidly without compromising tolerability, this approval represents an important advancement in care.

BESREMi® was approved in Japan in March 2023 for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of existing therapies. Under the previously recommended dosing schedule, treatment begins at 100 mcg, with 50 mcg increases every two weeks up to a maximum of 500 mcg. Under the new dosing regimen, patients receiving BESREMi® can reach the clinical maintenance dose more quickly than under the previous dosing regimen, supporting earlier disease control.

“We are grateful to the Japanese regulatory authorities for their recognition of the clinical value of the high-dose regimen,” said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer of PharmaEssentia. “This approval reflects our commitment to optimizing treatment strategies for patients. We are confident in the clinical and commercial potential of the high-dose regimen and will continue to benefit more patients with PV 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 and the developer and owner of BESREMi® (ropeginterferon alfa-2b-njft). 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 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 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 Contact
Muriel Huang
Director, Investor Relations and Corporate Communication
muriel_huang@pharmaessentia.com

PharmaEssentia Announces Plans to Establish New U.S. Manufacturing Facility in Puerto Rico to Support Global Growth of BESREMi®

US$46 million investment to establish wholly owned Puerto Rico subsidiary supporting U.S. manufacturing, supply security, and long-term growth of BESREMi® (ropeginterferon alfa-2b)

Company plans to obtain regulatory approval and commence operations at its Puerto Rico manufacturing facility in 2027

BURLINGTON, Mass, Feb. 9, 2026–PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical company headquartered in Taiwan with deep expertise in the development of novel biologics for hematology and oncology, and its U.S. subsidiary PharmaEssentia USA Corporation today announced that the global corporate Board of Directors has approved an investment of approximately US$46 million to establish a new, wholly owned manufacturing subsidiary in Puerto Rico. The planned investment supports the company’s global manufacturing expansion strategy and is intended to serve as a future manufacturing center for the U.S. market and long-term global demand for BESREMi® (ropeginterferon alfa-2b).

The investment reflects sustained global demand growth for BESREMi®, particularly in the United States, as well as the potential additional demand growth from regulatory approvals of BESREMi® for new uses.

Puerto Rico is widely recognized as a leading global hub for pharmaceutical manufacturing, hosting a strong ecosystem of experienced talent, infrastructure, and regulatory expertise. The planned manufacturing facility is expected to provide several long-term strategic benefits for PharmaEssentia, including enhanced supply security, increased operational flexibility, improved cost efficiency, and scalable manufacturing capacity to support future growth.

“Expanding manufacturing capacity outside Taiwan is a core strategic priority for PharmaEssentia as we continue to strengthen supply resilience, scalability, and geographic diversification,” said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer of PharmaEssentia. “We are proud to take this important step toward establishing U.S.-based manufacturing, with Puerto Rico serving as a future center for the U.S. market. This investment underscores our long-term commitment to reliably serving patients worldwide as demand for BESREMi® continues to grow.”

“PharmaEssentia’s decision to establish a manufacturing operation in Puerto Rico underscores the island’s role as a strategic U.S. hub for life sciences and advanced manufacturing,” said Governor of Puerto Rico Jennifer González. “This investment strengthens supply-chain resilience, creates high-value jobs, and reinforces Puerto Rico’s position as a trusted location for biopharmaceutical innovation and production serving patients in the United States and around the world.”

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 and the developer and owner of BESREMi® (ropeginterferon alfa-2b-njft). 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.

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 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.

Media

Muriel Huang
Director, Investor Relations and Corporate Communication
muriel_huang@pharmaessentia.com