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.
To create development plans and trial designs with the aim of obtaining marketing approval in the shortest time, we work to properly understand unmet needs of the healthcare frontline by analyzing target diseases multilaterally. We also proceed with activities with the Discovery and Research Division to shorten the period from commencement of drug discovery to establishment of efficacy and safety in humans (POC). In addition, we are speeding up collecting the data required for filing applications for marketing approval in Japan, South Korea, and Taiwan by conducting multinational clinical trials and advancing mutual use of results from overseas studies with our partners.
In April 2019, we strengthened our system for promoting quality enhancement and speedy clinical development by newly establishing within the Clinical Development Division a CRO Management Department specifically designed to increase in quality of trials and in efficiency of relevant management tasks, including clinical trial quality control and regulatory inspection handling. Currently, we have almost as many as 100 clinical trials ongoing mainly in the immuno-oncology domain, one of our key strategic areas.
In clinical development in the oncology domain, we are progressing investigation of biomarkers and combination therapies as a pioneer in cancer immunotherapy to provide patients with better treatment options.
Starting in January 2018, we have an Oncology Clinical Development Department in place, 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.
A similar organizational structure was set up for clinical development in the primary care domain. In October 2018, we reorganized the Primary Care Clinical Development into the Early Clinical Development Planning for early clinical development stage and the Clinical Development Planning for late clinical development stage.
We have strengthened our system that can accelerate implementation of POC establishment and validation study, so as to meet the needs of frontline healthcare as soon as possible.

Development Pipeline Progress Status