Bora Pharmaceuticals is advancing R&D by focusing on key therapeutic areas and innovative drug delivery technologies. We continuously improve development efficiency and leverage internal and external resources to meet market needs. With a strong talent base and commitment to quality, Bora develops functional ingredients and formulations that prioritize patient health and safety.
Innovative R&D Organization
A. Dedicated R&D Department
Bora has established dedicated departments, including the R&D NDA Division and R&D Clinical Group. The relevant roles and responsibilities are outlined as follows:
| Responsible Department | Duty |
|---|---|
|
R&D NDA Division |
|
|
R&D Clinical Group |
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
| 2022 | 2023 | |
|
Personnel |
67 |
81 |
|
Average R&D Experience (Years) |
9.55 | 9.09 |
3. R&D Expenditure
|
Year Item |
2022 |
2023 |
|
R&D Costs (in TWD Thousands) |
129,078 |
298,160 |
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 Experiments
To ensure ethical conduct in preclinical animal testing, we partner with GLP-certified domestic contract research organizations (CROs). These organizations are required to comply with Institutional Animal Care and Use Committee (IACUC) regulations and uphold the 3Rs principle— Refinement, Reduction, Replacement— aligned with Animal Welfare Committee directives. Currently, we work with 3 qualified domestic CROs and will apply the same standards to select international institutions in future studies.
B. Commitment to Monitoring and Auditing Clinical Trials
Our clinical trials are conducted through international CROs in the US, Canada, India, China and other countries. For trials submitted for regulatory approval, independent QA firms are engaged to oversee Quality Assurance and Quality Control.
We are committed to developing and implementing tailored “Monitoring Plan” and “Auditing Plan” based on trial risk levels. These efforts ensure the protection of participants’ rights and well-being, in compliance with GCP standards and trial protocol, and the accuracy and integrity of data collection, reporting and documentation.