New Drug Research and Development

We are accelerating and evolving our R&D approach in order to continually:

Build prominence and leadership in our focused therapeutic areas and differentiated drug delivery technologies
Enhance the efficiency and productivity of our R&D efforts
Instill a value of innovation that attracts and retains the best talent

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.

We have established dedicated departments, including the R&D NDA Division and R&D Clinical Group. The relevant roles and responsibilities are outlined as follows:

Our Innovative Research Productivity ambition is to:

Deliver 1~2 Investigational New Drugs (INDs) per year
Accelerate development time; for reformulating and repositioning products, targeting for a median of 2~3 years from first-inhuman trials to approval

Our commitment to innovative research in our focused therapeutic areas and product innovation extends to a multitude of actions that help ensure we are developing more sustainable and accessible products to support a healthier community. We are committed to expand our Access to Medicine program to cover our newly developed products after the products approval and commercial launch.

Clinical Trial Standards

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.

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.

Making Success More Certain

Our team is here to discuss how we can become a trusted partner to help bring your breakthrough drug successfully to market.