For People’s Health and Well-being
The Kyowa Kirin Group advances its CSV*1 management by capitalizing on its distinctive business foundation. While fulfilling our mission as a pharmaceutical company by discovering innovative new drugs and supplying them on a stable basis, we strive to solve social health-related issues and enhance people’s quality of life (QOL) to contribute to the health and well-being of people around the world.
- *1:CSV stands for "Creating Shared Value" and refers to realizing improved corporate value through both the creation of social value and the creation of economic value by addressing social issues.
Providing Health-oriented Customer Value
There are therapeutic areas where no or only insufficiently effective treatment is available and breakthrough drugs are coveted by patients and the medical community. By developing innovative new drugs based on cutting-edge biotechnology, expanding indications and adding new formulations, and offering stable supplies of high-quality drugs, Kyowa Kirin endeavors to fulfill unmet medical needs around the world.
In the area of research and development, we are making progress in developing global strategic products such as burosumab (KRN23), mogamulizumab (KW-0761) and istradefylline (KW-6002). Notably, burosumab (KRN23), an anti-FGF23 fully human monoclonal antibody, which we have been jointly developing with Ultragenyx Pharmaceutical Inc. as a therapeutic drug for hereditary rickets and osteomalacia, received approval from the U.S. Food and Drug Administration (FDA) in April 2018 and was launched under the brand name Crysvita® in the U.S. market. In February 2018, the drug was also granted conditional approval from the European Commission to be sold as a pharmaceutical product in Europe.
Meanwhile, mogamulizumab (KW-0761), an anti-CCR4 humanized monoclonal antibody, was granted breakthrough therapy designation by the USFDA in 2017. We have also applied for marketing approval of the drug in Europe and the United States.
Addressing Social Needs to Contain Medical Costs
FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd. is leveraging its innovative production technology to develop low-cost and high-quality biosimilar products*2 that can be stably supplied in the global market. Biosimilars respond to social needs for containing medical costs, and their markets are expected to expand worldwide.
In May 2017, the application for marketing approval of adalimumab biosimilar (FKB327), a fully human anti-TNFα monoclonal antibody, was accepted in Europe.
In addition, Kyowa Kirin Frontier Co., Ltd. is working to obtain approval for the domestic manufacture of "Authorized version*3" of NESP®, a core product of Kyowa Kirin.
By harnessing our latest biopharmaceutical manufacturing technology, we intend to ensure stable and efficient delivery of high-quality products with the aim of responding to social needs to contain medical costs.
- *2:A biosimilar product is a pharmaceutical with equal or identical quality, safety and efficacy to the original biopharmaceutical approved as a new drug on which it is modeled. Biosimilars are developed, manufactured and marketed by a company different from the manufacturer of the original drug, based on guidelines on biosimilars.
- *3:Kyowa Kirin thinks "Authorized version" is an identical drug to the branded drug in terms of active pharmaceutical ingredients, excipients and manufacturing method and which are manufactured and marketed by a company that receives the rights to exploit the branded drug’s patent from the company that owns the patent.
Contributing to Enhancing Global Health
"Global health" refers to a field where cooperative and collaborative efforts of the entire international community are required to solve issues exerting impacts on human health on a global scale. The Sustainable Development Goals (SDGs) adopted by the United Nations in 2015 positions global health as an internationally significant issue.
Participating in the Global Health Innovative Technology Fund (GHIT Fund)
Since 2016, Kyowa Kirin has been participating in the GHIT Fund, a public-private partnership for promoting discovery of new drugs for infectious diseases in developing countries. We will be participating in the second phase of the activity, which will start in fiscal 2018.
A public-private partnership jointly funded by the Government of Japan, Japan’s leading life science companies, the Bill & Melinda Gates Foundation, the Wellcome Trust, and the UN Development Programme (UNDP), the GHIT Fund is the world’s first of its kind to exclusively tackle product development in the global health field.
By endorsing the GHIT Fund’s objective of establishment and activities and by supporting its activities to deliver new drugs to patients with currently untreatable diseases, Kyowa Kirin aims at contributing to the enhancement of global health.
Contributing to anti-doping activities
Misuse and abuse of medicine for doping in sports not only dangers athletes’ health and the fairness of competition but also damages the medical development sustainability in pharmaceutical industry.
In September 2019, Kyowa Kirin has signed a memorandum of understanding with WADA to prevent the misuse and abuse of medicines for doping in sports.
Kyowa Kirin will support WADA in its fight against doping in sports by reviewing any of its compounds in development with the potential for sports-related abuse and sharing relevant information to WADA for preventing misuse and abuse of medicines for doping in sports.
Contributing to Solving Health-related Social Issues
The Kyowa Kirin Group makes donations to foundations and engages in activities to raise awareness on various diseases with the aim of contributing to solving health-related social issues.
Contributing to enhancing medical care and advancing medical and pharmaceutical sciences
Hoping to promote an interest in science among the broader population, we publicly share information on biotechnology and make donations to the Kato Memorial Bioscience Foundation*, which supports the development of the next generation of researchers.
Helping raise awareness on diseases
Employees at our business sites across the world participate with their family members in charity events held to help people better understand certain diseases.
- Charity marathon in support of pediatric cancer patients (Korea)
- Charity marathon in support of Parkinson’s disease patients (U.S.A.)
- Charity walk event in support of leukemia and lymphoma patients (U.S.A.)
Kyowa Kirin publishes "Cutaneous T-cell lymphoma (CTCL) Patient Experiences Report"
Kyowa Kirin International PLC has published "Cutaneous T-cell lymphoma (CTCL) Patient Experiences Report" which highlights the experiences of three individuals diagnosed with CTCL. Kyowa Kirin Group is deeply committed to working with patient communities to drive awareness, give patients a voice and empower those affected by rare diseases. Through this report, Kyowa Kirin International PLC demonstrates how CTCL affects the everyday lives of people who live with this condition.
In this report, Al from Norway, Ellie from the UK and Frederic from France who all live with CTCL, share their stories of life with this rare cancer. They explain the very real and significant impact the disease has had on their day-to-day life.
Whilst each individual’s story is unique, there are parallels across all three and through continued collaboration, opening up dialogues and advancing innovative science and technology, we want to bring hope for these patients worldwide, whose voices are not always heard.
All of Kyowa Kirin is grateful to Al, Ellie and Frederic who have shared their stories, in the hope of helping others in a similar situation and would also like to thank Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation for writing the foreword to the report.
White Paper on the unrecognized burden of XLH in adults in Europe
A White Paper "The unrecognized burden of XLH in adults – A call for action" that aims to identify the unmet needs of adults living with the disease in Europe have been published in collaboration with medical experts and patient communities.
X-linked hypophosphatemia (XLH) is a genetic form of rickets causing debilitating abnormalities in the bones, muscles and joints. The disease has historically been considered a childhood disease, but the white paper seeks to provide a greater understanding of the challenges faced by adults with XLH and highlight what is needed in society to support people living with the condition throughout their life.
The study was conducted by Kyowa Kirin International PLC and expert authors Pol Harvengt (RVRH-XLH, French member association of the International XLH Alliance), Dr Lothar Seefried (Orthopedic Institute, König-Ludwig Haus, Würzburg, Germany), Dr Michael Smyth (Pharmaceutical physician and former employee of Kyowa Kirin International, Galashiels, UK) and Dr Richard Keen (Royal National Orthopaedic Hospital, Stanmore, UK).
Findings show that XLH causes severe pain, musculoskeletal deficits and mobility issues in adulthood with life-long psychosocial impacts, affecting not only the individual, but also their family, society and the healthcare system. In a survey amongst XLH patient associations, continued access to treatment in adulthood was ranked as one of the top priority unmet needs, as well as improving awareness among healthcare professionals of the need for ongoing specialist care.Furthermore, there is a strong need to recognise XLH as a lifelong disease and ensure integrated, high-quality care at all life stages, and to strengthen EU-level collaboration to address the inequality of disease burden and management across Europe.
Kyowa Kirin is grateful for the vital insights, support and counsel provided by the expert authors, the XLH Alliance Network, as well as to those adults involved with XLH and their clinicians. This is a great example of critical collaboration between medical and patient communities to develop a White Paper that make an important contribution to the medical literature. Our special gratitude goes to Oliver Gardiner (Chair of XLH UK and Co-Chair of the International XLH Alliance) and Tia Haverinen (Board member of Finnish Kalfos Ry) for their contributions.