Bora Pharmaceuticals is committed to accelerating research and development capabilities of its pharma sales operations, focusing on key therapeutic areas and breakthroughs in innovative drug delivery technologies and dosage form. The Company upholds values of innovation to attract and retain key talents, combining internal and external resources to develop functional ingredients and formulations that meet market demand, safeguarding patient health and safety.
Innovative R&D Organization
A. Dedicated R&D Department
Bora has established dedicated departments, including the R&D Department for branded drugs and the Clinical Team. The related positions and responsibilities are summarized as follows:
| Responsible Department | Duty |
|---|---|
| R&D Department for branded drugs |
|
| Clinical Team | Manages and facilitates pre-clinical animal trials and clinical trials. |
B. Investment in Research and Development Resources
1. Talent Policy
- Expands technical exchanges with overseas subsidiaries and provides on-site training
- Offers job rotation and promotion paths across multiple production sites
- Promote R&D collaboration with international pharmaceutical companies.
2. Number of R&D Personnel
| 2023 | 2024 | |
| Personnel | 81 | 78 |
| Average R&D Experience (Years) | 9.09 | 9.18 |
3. R&D Expenditure
| Year Item | 2023 | 2024 |
| R&D Costs (in TWD Thousands) | 298,160 | 694,487 |
Achievements and Plans in Innovative R&D
Over the past decade, Bora has built a strong foundation in developing hard-to-formulate and controlled release generic pharmaceutical products for the US market, offering patients affordable, high quality essential medicines.
To further address the unmet medical needs, we have shifted our focus of research and development from generic products to innovative medicines. Our development strategy now focuses on central nervous system diseases (CNS), with further concentration on epilepsy/seizure, ADHD, and depression, especially for pediatric patients.
We continue to strengthen our core technologies in nano-formulation, controlled-release, and prodrug design platform to drive innovation through re-formulation, repurposing, and new combinations—enabling us to develop potential “best-in-class” treatments for diseases in our focus areas, such as rare pediatric epilepsy, and other high unmet medical needs.
Clinical Trial Standards
A.Commitment to Animal Welfare in Preclinical Animal Studies
To ensure compliance with animal welfare, Bora Pharmaceuticals selects GLP certified contract research organizations (CROs). These organizations must follow the Institutional Animal Care and Use Committee (IACUC) regulations and adhere to the 3R principles (Refine, Reduce, Replace). This approach complies with the animal welfare committee guidelines for humane experimentation. Currently, we have contracted 3 qualified CROs in Taiwan for preclinical animal studies. We commit to applying the same standards to our overseas subsidiaries in the future.
B. Standards for Clinical Trial Monitoring and Auditing
Bora collaborates with international research institutions to conduct clinical trials in countries including the United States, Canada, India, and China. All clinical trials intended for regulatory submission are conducted by independent clinical trial quality assurance organizations to ensure rigorous quality oversight. Through
contracted CROs, risk-based monitoring and audit plans are developed and implemented to ensure the quality and integrity of investigational drug studies. Participant rights and welfare are prioritized, with strict adherence to trial protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements to ensure full compliance in trial execution, data collection, documentation, and reporting.