Development Policy

Development Policy

Upholding the corporate philosophy “Dedicated to the Fight against Disease and Pain,” our group takes on the challenge against diseases that have not been overcome so far, and the disease area which has a low level of patient satisfaction with treatment and high medical needs. We are endeavoring to make creative and innovative drugs. Currently, the development pipeline comprises new drug candidate compounds of anticancer drugs including antibody drugs in addition to Opdivo, candidates for treatment of autoimmune disease and neurological disorder, and so on, and development is proceeding. Among these, the area of cancer treatment is positioned as an important strategic field because medical needs are high.

Early establishment of PoC*

ONO is working to expedite clinical development and improve the success rate of drug candidates in order to fast-track the delivery of our in-house and in-licensed compounds to patients suffering from diseases around the world. We are flexibly utilizing our clinical development functions in Japan, the US and Europe to quickly establish PoC to expediently identify the potential product value of candidate compounds. To do this, we formulate appropriate clinical development plans, including target disease selection, propose study plans to accurately evaluate efficacy, and promote studies according to the plan. Also, while advancing the search for clinical markers through translational research, we launch new discovery research projects using results obtained from clinical trials, creating an R&D virtuous cycle. We are also building a system to conduct global confirmatory studies after establishing PoC.

  • PoC (Proof of Concept): PoC studies are an early stage of clinical drug development to confirm whether the drug candidates demonstrate the clinical safety and efficacy expected during the drug discovery phase.

Number of products in the clinical development stage

We are also proceeding with clinical development of existing products to maximize product value. For Opdivo, we are conducting clinical trials aimed at expanding the range of cancer types, using the drug at earlier lines of treatment, and establishing combination therapies to enhance therapeutic efficacy. We are also focusing on expanding our pipeline beyond Opdivo, maintaining the number of products in the clinical development stage at more than 20 over the past several years. To improve the speed and quality of our clinical trials, we are digitizing our operations.
We will continue to aggressively pursue clinical development not only in Japan but also worldwide for the benefit of patients awaiting new therapeutic agents.

Global Clinical Development System

Establishment of Development Systems in the US and Europe by Setting Up Local Centers

In the US and Europe, our local subsidiaries, ONO PHARMAUSA, INC. (OPUS) and ONO PHARMA UK LTD. (OPUK), will further advance and establish organizational stucture that enable us to, in addition to early-stage clinical trials, conduct late-stage clinical trials and apply for approval with the regulators.