Research & Development

Development Organization

Global Clinical Development System

To promote clinical development efforts in Asia based in Japan, we have established the Asian Development Division within our headquarters and have been actively expanding into the Asian market including by commercializing the world’s first anti PD-1 antibody drug OPDIVO. We established wholly owned subsidiaries, ONO PHARMA KOREA CO., LTD. (OPKR) in South Korea in 2013 and ONO PHARMA TAIWAN CO., LTD. (OPTW) in Taiwan in 2014, and have already launched our own marketing. We will engage in strengthening development activities in South Korea and Taiwan and expanding our developing activities into the rest of the region.
For development activities in the US and Europe, we have established nerve centers for clinical development within the overseas subsidiaries: ONO PHARMA USA, INC. (OPUS) and ONO PHARMA UK LTD. (OPUK). Both subsidiaries are pursuing overseas clinical trials of our new drug candidates.
We aim at the creation of systems where we can apply for approval on our own in the US and Europe in addition to Japan and the rest of Asia, by upgrading our drug development infrastructure in Japan, the rest of Asia, the US, and Europe, and making our global development system more efficient and speeding up clinical development.


Accelerated Clinical Development

We are committed to promoting clinical development with enthusiasm to deliver new drugs that meet the needs of frontline healthcare as soon as possible, for the benefit of people suffering diseases throughout the world.
We have integrated the functions necessary to bridge from research to clinical development at the Translational Medicine Center (TMC), a part of the Clinical Development Division, after further evaluation of the efficacy, safety and quality of promising new drug candidates at the basic research and non-clinical stages to enable quicker decision making in development to shorten the period from commencement of drug development to establishment of efficacy and safety in humans (POC).
Clinical development plays a role in collecting the data required for filing Ministry of Health, Labour and Welfare applications for marketing approval for prescription drugs. With the aim of obtaining marketing approval in the shortest time, we are speeding up the clinical development process by advancing mutual use of results from multinational clinical trials and other overseas studies.
Under the awareness of being a pioneer in cancer immunotherapy, we focus our efforts on oncology as a key strategic area and are working to strengthen our development capability, for example, by establishing the R&D Unit for Immuno-Oncology in December 2015, where we are progressing investigation of biomarkers and combination therapies. In January 2018, we set up an Oncology Clinical Development Unit, which consists of the Oncology Early Clinical Development Planning for early clinical development stage and the Oncology Clinical Development Planning for late clinical development stage, to shorten the time of oncology projects from early clinical stage to market launch for further speeding up clinical development.


Development Pipeline Progress Status