Research and Development

The Core Driver of Further Growth - Research and Development

Promoting Drug Discovery, Development and Life Cycle Management to Establish Our Presence in Specific Fields

The Discovery Research Division continuously licenses globally competitive, original drugs under our long-term vision HOPE100, and has set a goal of establishing a strong presence in the Compa¬ny’s specific fields (respiratory medicine, otolaryngology, and urology). To do this, it is important to build a highly productive organization by emphasizing timelines, and to fully explore the R&D processes from drug discovery to life cycle management: theme selection, evaluation, development period, and the introduction of new drug discovery technology. Under our medium-term business plan HOPE100 Stage 1 (Fiscal 2010 ? 2015), we are tackling the priority topics of doing research into life cycle management to maximize product value, steadily bringing development projects to market, and creating innovative new drugs under the key concept of creat-ing drugs that will change existing therapeutic systems. Under HOPE100 Stage 2 (Fiscal 2016 ? 2019), we will prioritize bringing to market development projects that include original new drugs. From HOPE100 Stage 3 (Fiscal 2020 ? 2023) onwards, we will focus on creating innovative new drugs that can contribute to the health of the world’s people.

In the drug discovery process, we aim to create innovative origi¬nal new drugs under the key concept of creating drugs that will change existing therapeutic systems, and are therefore focusing our limited resources on our specific fields. We are working to clar¬ify disease-specific issues to fuse the technologies of pharmacol¬ogy, drug synthesis, toxicity, ADME (Absorption, Distribution, Metabolism, Excretion), and CMC, and to speedily create attractive and high-quality drug candidates. Moreover, in our next-generation drug discovery research, we are working on the development of a gene-therapy drug that has the potential to treat diseases with substantial unmet medical needs, and have started a practical application program for an Ad-SGE-REIC formulation that targets the treatment of malignant pleural mesothelioma.

In the development process, we are guided by a consistent focus on the needs of the patients who will use the drugs, and this is based on understanding the importance of creating products that meticulously meet medical needs. In addition, we follow a “developer-producer” approach in which we formulate development policies with a strong awareness of our vision for a product after launch. In line with this, we give ample consideration to marketabil¬ity, profitability and feasibility, and are continuing to create drugs by pursuing effectiveness, safety and convenience. Currently, we are working on the development of KRP-114V, an overactive bladder drug; KRP-AM1977X and Y, a new quinolone synthetic antibacterial agent; KRP-209, a treatment for tinnitus; and other drugs, with the goal of bringing them quickly to market.

In the life cycle management process, we work to build evi¬dence by implementing scientifically high-value research into life cycle management (clinical research, drug additions, etc.), thereby maximizing product value.

To Create Drugs That Meet Market Needs

With medical needs continuing to expand and becoming more sophisticated, KYORIN Pharmaceutical meets the challenges of developing new drugs. One of our strengths is our relatively small scale, exploiting the benefits of collaboration between individuals with a broad range of research expertise and departments that can quickly make judgments and respond. In May 2015, we completed the WATARASE Research Center, a new R&D facility, and it opened in July the same year. In our R&D Department, we have reshuffled the organization based on our business strategy. The organization now ties together four units (respiratory medicine, otolaryngology, urology and new foundation research) for each disease domain, with each unit bearing responsibility from research to product com¬mercialization. As a result, we can shorten the transition time from the discovery of a new drug candidate compound to the development and commercialization of the drug, and we can strengthen the pipelines in specific fields. Furthermore, we are pro¬moting not just research within the Company but also collaboration with academia (research with universities, research institutes and through other ventures). We will select highly original research themes and pursue R&D activities. We are doing our utmost to focus our efforts on practical applications so that we can provide patients with new therapies as soon as possible.

We founded the WATARASE Research Center as a new R&D facility that unites in one research institute the research activities that had hitherto been dispersed in two locations. The WATARASE Research Center is a facility with state-of-the-art equip¬ment and instruments that organically connects individual research capabilities, and that encourages ease of communication between researchers. The Product Portfolio Planning Department ties together four units (respiratory medicine, otolaryngology, urology and new foundation research) that formulate a strategy for each disease domain, and there are eight drug research institutes (Pharmacology 1, Pharmacology 2, Synthesis 1, Synthesis 2, Safety, Pharmacokinetics, CMC, and Drug Discovery Technologies). This matrix organization structure promotes new drug creation both effectively and efficiently, enabling us to clarify the treatment domains and diseases that Kyorin should engage in, and to undertake new drug creation in line with market needs.

To respond to the diverse and increasingly sophisticated medical needs of today, we must integrate Kyorin’s technologies and knowledge and exhibit our collective power even more than hitherto. Furthermore, we also need to develop attractive and high-quality products by combining the wisdom and technologies of external bodies such as academia, startup companies and other partners. We must not only think of drugs as merely something with medicinal properties. Rather, we should think that drugs enable us to make a good impact on patients and their families, healthcare professionals and medical treatments. In short, Kyorin aims to become a new-drug creator that is recognized for its presence in society.

WATARASE Research Center and New pharmaceutical discovery research laboratories

Focus on Timelines in Research and Development

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