Chugai’s Seven Strengths
Chugai has identified the “seven strengths” that are the source of its unique value to help stakeholders recognize and understand its efforts to realize its goal of a becoming a top pharmaceutical company. We continue to work on the further evolution of these strengths.
- 1. High product potential that addresses unmet medical need
*1: Copyright © 2017 QuintilesIMS. Source: JPM 2016 Reprinted with permission.
The scope of the market is defined by Chugai
Chugai has the number-one market share in the domestic oncology field and in the therapeutic antibody market, and has market-leading products for bone and joint and renal diseases. Chugai also leads the therapeutic antibody field by establishing proprietary antibody engineering technologies based on its experience in discovering and developing Japan’s first therapeutic antibody.
Chugai’s innovation has been highly evaluated for its many products eligible for Japan’s new premium pricing system to promote the development of new drugs and eliminate off-label use.*2
*2 A system implemented on a trial basis as a measure to encourage creation of innovative drugs and development of off-label-use drugs
- 2. One of the richest pipelines in Japan
The pipeline – drug candidates currently being developed – is the source of value that leads to the creation of new medicines. Having a rich development pipeline is a major strength, and with in-house projects and others in-licensed from Roche, Chugai’s pipeline is one of the richest in Japan and supports the continuous generation of products that address unmet medical need. In addition, Chugai leads the domestic pharmaceutical industry in participating in multinational clinical studies*3 to expand the value of its medicines globally.
*3. Clinical studies conducted concurrently in multiple countries or regions
- 3. Strategic alliance with the Roche Group
The strategic alliance with Roche, one of the world’s leading pharmaceutical companies, allows Chugai to in-license Roche’s therapies in Japan while utilizing the Roche Group’s powerful research infrastructure and network to deliver Chugai products to patients worldwide. Furthermore, Chugai is cooperating with Roche in global development and in simultaneous development of personalized healthcare (PHC)*4-based medicines and companion diagnostics. Through these initiatives, Chugai is creating best practices in development and filing in Japan.
*4. An approach of selecting the most appropriate treatment by using biomarkers and diagnostic tests to identify patients most likely to show a significant response to a particular drug
- 4. Cutting-edge drug discovery technologies, especially biotechnology
With more than three decades of experience in biopharmaceutical research and development, Chugai has developed a series of proprietary antibody engineering technologies. Our drug discovery capabilities, including for small molecule drugs, have reached a world class level. For example, Chugai has obtained five BTDs from the FDA. Chugai discovered and developed Japan’s first therapeutic antibody, which is now approved in 115 countries. Through that experience, Chugai has continued to evolve its expertise in creating antibodies, including joint research with academia. In recent years, Chugai has developed a series of innovative antibody engineering technologies, and has increased its patent portfolio in addition to its publications in academic papers and presentations at scientific conferences. It has also made structural improvements, such as establishing a subsidiary in Singapore, Chugai Pharmabody Research, to conduct research focused on antibody discovery. Moreover, we have selected drug discovery technologies for middle molecules*6 as a candidate for our next-generation core technology in addition to antibody engineering and small-molecule technologies, and aim to build a strong base for this new technology and quickly generate projects.
*5. A system introduced in July 2012 by the U.S. Food and Drug Administration aimed at expediting the development and review of drugs for the treatment of severe or life-threatening diseases or symptoms.
*6. Middle molecules are technology of significant potential which enable approaching the target of diseases that are difficult to target with antibodies and small molecules.
Mechanisms of antibody therapeutics and an introduction to Chugai’s next-generation antibody engineering technologies
- 5. Knowledge and experience as a pioneer in personalized healthcare (PHC)
Chugai is an active player in PHC, where optimal treatment is planned for each patient, according to the patient’s unique molecular and genetic profiles. In addition to its strong therapeutic effect and reduced side effects, PHC is also considered beneficial from an economic (medical cost) perspective because it allows treatment to be avoided in cases where it is unlikely to be effective.
Chugai is also partnering with Roche’s Diagnostics Division, which has the top global market share in diagnostics, in promoting simultaneous development of therapies and companion biomarker diagnostics.
*7. An approach of selecting the most appropriate treatment by using biomarkers and diagnostic tests to identify patients most likely to show a significant response to a particular drug
- 6. Commitment to safety management
In Japan and overseas, Chugai practices comprehensive safety management to promote the safe and appropriate use of its medicines. We have also established a global-level safety information collection, evaluation and analysis system based on our experience with over 20,000 all-case registration surveillance studies and safety management for products in the fields of oncology and bone and joint diseases. Our reputation for safety evaluation is first-class among healthcare providers in Japan. Moreover, to establish a plan – do – check cycle in our post-marketing pharmacovigilance activities, we collect and analyze information consistently from the preclinical and clinical trial stages, and have drawn up and carried out risk management plans (RMPs) for nine of our products since 2012, ahead of our competitors.
- 7. Support for healthcare delivery
With their high level of expertise, Chugai’s oncology and other medical representatives (MRs) focus on consultation-based promotions that involve the provision of information and treatment proposals based on scientific data on therapies and side effect management. Chugai also provides a variety of information and holds seminars to promote multidisciplinary team care – cooperative treatment and care by doctors and other healthcare providers – and regional healthcare coordination, which has been emphasized in recent years. These efforts have earned a high evaluation and strong support from healthcare providers.
*8. A post-marketing clinical study scheme to guarantee the independence and transparency of research
*9. Staff certified by Japan Society of Clinical Trials and Research (JSCTR) as having adequate understanding of the good clinical practice (GCP) guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Japanese GCP (J-GCP).
The Process of Identifying Our Seven Strengths
In our project to become a top pharmaceutical company, which started in 2009, we visualized the intangible strengths that Chugai has built, and shared 96 examples of those strengths within the Company.
Analysis of Value and
Based on those 96 examples, in 2013 we evaluated and analyzed Chugai’s strengths from the standpoints of value to patients and competitive advantage, resulting in 25 categories.
Distillation Down to
We organized these 25 categories through outside analysis and other means and distilled them down to seven strengths, establishing a basic message for communications.