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.

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