PharmaEssentia is committed to advancing proprietary research and development technologies that not only drive breakthroughs in the biopharmaceutical industry but also deliver greater benefits to patients. Throughout the entire pharmaceutical lifecycle—from new drug research and development, production and manufacturing, and transportation to commercialization—every stage is subject to rigorous and comprehensive compliance with applicable regulatory and quality requirements. PharmaEssentia also continuously identifies patentable innovations arising from its R&D activities and strengthens patent protection, while implementing comprehensive intellectual property protection strategies to maximize the lifecycle of its core products. We also place strong emphasis on post-marketing risk management by continuously monitoring and reporting drug safety information, thereby fulfilling our responsibility to safeguard patients’ rights and well-being.
Achievement Highlights
Corresponding SDGs
New Drug Research and Development and Innovation Management
R&D Focus
As an innovative pharmaceutical company focused on R&D of new drugs and biopharmaceuticals, PharmaEssentia continues to invest in research on rare diseases amid rapid advances in medical technologies and global aging trends, particularly emphasizing R&D on MPN drugs. MPN mainly encompasses four main disease categories:
- Polycythemia vera (PV)
- Essential thrombocythemia (ET)
- Chronic myeloid leukemia (CML)
- Primary myelofibrosis (PMF)
Many patients around the world are facing long-term health challenges caused by MPN, and the biopharmaceutical industry is actively working to develop related treatments. We leveraged our independently established PEGylation technological platform to optimize existing therapies and develop a new-generation PEG long-acting interferon alfa2b (Ropeg). This drug has multiple indications and breaks through traditional limitations in interferon administration and treatment. We have already obtained marketing authorizations for PV, and continue to expand into other indications to enhance the therapeutic value of this drug.
PharmaEssentia has also extended the PEGylation technology platform to other R&D product lines, including:
- Long-acting interleukin PEG-IL-2
- Bispecific antibody fusion protein PD-1/IL-2
- Antibody-drug conjugates (ADCs)
- Two cell therapies (NY-ESO-1 TCR-T and innovative TCR-T)
We strive to provide novel treatments for multiple diseases by expanding our technological applications to enhance medical accessibility and treatment efficacy.
Although the development of new drugs involves significant technological challenges, long development timelines, and substantial capital investment, we have consistently upheld a “patient-oriented” philosophy which leverages our pharmaceutical expertise and industry experience. We continue to invest in innovation and R&D so we can improve patient quality of life, deliver clinical value, and steadily work to become a global benchmark company in the biotechnology and pharmaceuticals industry.
Product Recall Performance
PharmaEssentia has established product traceability and recall management procedures to ensure rapid response to potential quality concerns. No product recalls, including Class I* or Class II** recalls (or equivalent), occurred during FY2022-FY2025. The Company continues to maintain a zero product recall record through its quality management, pharmacovigilance and product safety management systems.
Product Recall Performance
FY2022
FY2023
FY2024
FY2025
Class I Recalls
0
0
0
0
Class II Recalls
0
0
0
0
*Class I recalls refer to product defects that may cause serious adverse health consequences or death.
**Class II recalls refer to product defects that may cause temporary or medically reversible adverse health consequences.
The following is a summary of R&D and clinical trial progress made on PharmaEssentia drugs in 2025:
R&D Expenditures Over Past Five Years
PharmaEssentia Global Certification LandscapeRegulatory Agency Inspections
Regulatory agency inspections
FY2022
FY2023
FY2024
FY2025
Number of inspections
5
5
2
1
Note1：PharmaEssentia did not receive any Form 483s (or equivalent) in the last four years.
Note 2：PharmaEssentia did not receive any Warning Letters (or equivalent) in the last four years.
Drug Quality and Product Safety
PharmaEssentia Global Certification Landscape
PharmaEssentia (Taiwan) pharmacovigilance education and training information for 2025:
Pharmacovigilance education and training for overseas subsidiaries:
Drug Safety Reporting Mechanisms
Drug Safety Management and Marketing Ethics
Drug Quality and Safety Management
PharmaEssentia is committed to developing proprietary R&D technologies that drive breakthroughs in the biotechnology and pharmaceutical industry and improve patient well-being. We comply with pharmaceutical regulations and quality requirements at every stage, from innovative drug development and manufacturing to distribution and market launch. We continuously pursue patent protection for our innovative R&D technologies and strengthen our patent portfolio through a range of foundational and complementary protection measures to maximize the core product lifecycle. We also place great emphasis on post-marketing risk management, continuously monitoring and communicating information on the safe use of our products to fulfill our responsibility to safeguard patients' rights and interests.