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.--(BUSINESS WIRE)--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.

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.