Policies

Last Updated: April 2024

1. Background

Nxera Pharma Co., Ltd. and any firm, company, corporation or other organisation which is a subsidiary, affiliate or registered branch for the time being of Nxera Pharma Co., Ltd. (collectively, “Nxera”) is passionate about improving the quality of life and health of people around the world through the discovery and development of effective and safe medicines.

The laws and regulations on development and testing of new medicines require us to assess the potential benefits and risks of a candidate drug in animals before testing the candidate drug in people.

Modern scientific techniques analysing gene and protein expression in humans provide insights into the biological processes that are disturbed in disease and allow us to identify candidate drugs to correct these disturbances. We initially test these candidate drugs in the laboratory on isolated proteins and in cultured cells without needing to use animals. Only after a candidate drug has shown potential in these initial tests do we consider animal studies.

Studies in living animals are important to confirm that the drug works the same way inside the body as it did in the laboratory testing. They also indicate how the drug affects the interactions between different cells and organs of the body and if it is likely to be safe in humans.

There are currently no alternatives acceptable to regulatory authorities that fully replace animal research, but we are committed to the humane and ethical treatment of all animals used to help develop new medicines.

2. Nxera’s Commitment to Ethical Treatment of Animals

Nxera is committed to the humane and responsible use of animals in biomedical research.

No animal research is conducted in our laboratories or premises. Instead, we work with experienced and reputable Contract Research Organisations to conduct any necessary research. Our Contract Research Organisations are selected following careful assessment, and we strive to work with organisations that conform to the highest standard of legal and regulatory compliance processes, obtained through independent accreditation procedures.

All use of animals is carefully planned and reviewed by a team of scientists, statisticians and veterinarians before any research starts. We endeavour to abide by the 3R principles of Replace, Reduce and Refine, and only commission studies involving the use of animals where there are no scientifically appropriate alternatives. Through our internal review processes, we work to ensure that all experiments are designed to use the minimum number of animals possible to deliver the required data in the circumstance and minimize or avoid unnecessary pain, distress, or discomfort to the animals.

3. Nxera’s Commitment to Alternatives to Animal-based Biomedical Research

Nxera is committed to the development and use of scientifically validated alternative testing methods that are acceptable to regulatory authorities and do not compromise patient safety or the effectiveness of our medicines.

Nxera has invested heavily in methods to test effects of candidate drugs on isolated human cells and in clusters of cells grown in the laboratory (organoids), and in the use of state-of-the-art computational modelling to predict the effective concentration of the drug in the body and biological effects in humans.