New Drug Research and Development

Management Approach：

Bora Pharmaceuticals is dedicated to accelerating its R&D capabilities, focusing on breakthroughs in key therapeutic areas and innovative drug delivery technologies, while continuously enhancing R&D efficiency and productivity. Guided by a commitment to innovation, Bora attracts and retains exceptional talent, leveraging both internal and external resources to develop functional ingredients and formulations that meet market demands, ensuring the health and safety of patients.

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:

B. Investment in Research and Development Resources

1. Talent Policy

• Increase opportunities for technical exchanges with overseas subsidiaries and provide internships and training at different production facilities.
• Offer diverse job rotation and promotion opportunities, allowing R&D personnel to gain experience across various production sites.
• Foster R&D collaboration opportunities with international pharmaceutical companies.

2. Number of R&D Personnel

3. R&D Expenditure

Achievements and Plans in Innovative R&D

Bora established our strong footprint of developing hard-to-formulate and controlled release generic pharmaceutical products for US market through the past decade, providing affordable and accessible high quality essential medicine to the patients.

To further address the unmet medical needs, we have shifted our focus of research and development from generic products to innovative medicines. We are actively working to expand our product portfolio and enhance our approach to R&D so we can deliver more medicines to more patients faster. Our focused therapeutic area is central nervous system diseases (CNS), with further concentrating on epilepsy/seizure, ADHD, and depression, especially for pediatric patients.

We are continually developing our core expertise and technology strength in nano-formulation platform, controlled-release platform, and prodrug design platform to drive innovation through re-formulation, repurpose, and new combination, enabling us to yield potential “best-in-class” treatments for diseases in our focused therapeutic 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 adherence to animal welfare, our company selects domestic contract research organizations (CROs) that are GLP-certified. These organizations are required to comply with the regulations of the Institutional Animal Care and Use Committee (IACUC) and adhere to the 3Rs principle (Refinement, Reduction, Replacement). This approach aligns with the directives of the Animal Welfare Committee to conduct experiments humanely. Currently, we have contracted three qualified domestic CROs to carry out preclinical animal experiments. We are committed to use the same standards to select international institutions in future studies.

B. Commitment to Monitoring and Auditing Clinical Trials

We have used international contract research institutes to conduct clinical trials in US, Canada, India, China and other countries. All clinical trials for regulatory submission have been monitored for Quality Assurance and Quality Control by hired independent clinical trial QA companies. We are committed to continually develop and follow “Monitoring Plan” and “Auditing Plan” through contracted CRO based on risk level to ensure QA and QC. Ensure participant rights and welfare protection and compliance with trial protocols, GCP, and regulations regarding trial execution and data generation, recording and reporting.

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