Drug Discovery Flow
Kyowa Kirin's drug discovery process is divided into eight processes to integrate and maximize all our technologies, knowledge, and expertise, from research and development to manufacturing.
Process-Based Initiatives
Drug Discovery Incubation Research
We explore new possibilities at the molecular
and cellular levels—including genes and proteins—
and create drug discovery concepts to develop novel drugs.
Exploratory Research
Based on our drug discovery concept,
we explore “seeds (drug discovery seeds)”
from multiple perspectives.
Translational Research
This refers to research that bridges basic science
and clinical studies to ensure that drug discovery
technologies and seeds identified through early-stage
research can be effectively applied in clinical practice
to achieve therapeutic benefits.
Development Research
We comprehensively evaluate
drug discovery seeds from various
perspectives, including efficacy
and safety, to create valuable
new drug candidates.
Clinical Development
We have established global development sites
and conduct high-quality clinical trials
to evaluate efficacy and safety in accordance
with each country’s standards.
Production and Quality Assurance
Our manufacturing technologies and facilities meet
international standards. Through a rigorous checking
system that covers everything from Active
Pharmaceutical Ingredients to finished products,
we ensure stable supply of high-quality
pharmaceuticals worldwide.
Production Technology
Research
We develop processes that enable highly
efficient production and supply of high-quality
pharmaceuticals based on drug discovery seeds.
We also develop formulation technologies
to supply higher and more novel value to
our pharmaceuticals.
Post-marketing Drug
Development/Optimization
("Iku-yaku" in Japan)
Even after marketing approval, we continue to
enhance our drugs through post-marketing studies
that evaluate their risks and benefits, as well as
through formulation improvements
and value-added innovations.
?What is “post-marketing drug development/optimization ("Iku-yaku" in Japan)”?
After a drug has been launched, information obtained through clinical practice is used to improve its efficacy and safety, refine its usage, expand its indications, and thereby develop it to be more useful for patients.
Disclosure of Clinical Trial Information
Kyowa Kirin promotes transparency in clinical trials by complying with all applicable laws and regulations. We uphold the principles of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the Japan Pharmaceutical Manufacturers Association (JPMA), and we promote the disclosure of clinical trial information in ways that protect patient privacy.
1. Registration of Clinical Trial Information and Disclosure of Results
This system is used to submit implementation plans and other notifications to the Minister of Health, Labour and Welfare.
Click here for instructions
Information requested by the World Health Organization (WHO), as well as information that promotes transparency in the research process and encourages public participation in clinical research, is disclosed.
Operated and managed by the NLM, part of the National Institutes of Health (NIH).
This website provides information on clinical trials that is easily accessible to patients, their families, healthcare professionals, researchers, and the general public.
Click here for instructions
This website provides information on clinical trials of investigational pharmaceutical products initiated in the European Union (EU) or European Economic Area (EEA) from May 1, 2004, onward.
The data sets generated and analyzed in Kyowa Kirin’s clinical trials will be made available in the Vivli repository, provided that they meet the data disclosure conditions specified in the Vivli website policy.
2. Publication of Clinical Trial Results
Kyowa Kirin promotes disclosure of the results of Phase III trials and other medically important clinical trials in academic journals or in the form of posters and oral presentations at scientific conferences, regardless of the trial outcomes.
