Chugai and its Businesses
- Q01When was Chugai founded?
- The company was first established as Chugai Shinyaku Co., Ltd. in March 1925. 18 years later, in March 1943, the company was reorganized as a corporation based in Tokyo and assumed its present name as Chugai Pharmaceutical Co., Ltd.
- Q02What is Chugai’s management policy and vision?
Chugai has established its mission statement and Chugai Business Conduct Guidelines (Chugai BCG) as a code of conduct and set it as a business standard. In addition, we have formulated the mid-term business plan “IBI 18” with the final year ending in 2018.
Click below to view Chugai’s Mission Statement, Business Conduct Guidelines or the Mid-Term Business Plan in more detail.
- Q03What are the business risks for Chugai?
Chugai’s performance is subject to major impact from a range of factors. Principal risk factors are related to new product development, market environment changes, side effects, changes within the medical/insurance system, intellectual property rights, our strategic alliance with Roche, and foreign exchange rate fluctuations. There are other risk factors as well. The Company will make every effort to prevent, minimize and respond appropriately to the risks it faces.
To learn more about the risks Chugai prepares for, click the link below.
- Q04On which products and markets does Chugai focus?
Chugai is an R&D focused pharmaceutical company specializing in prescription drugs, especially biopharmaceuticals. Since entering into a strategic alliance with Roche in October 2002, Chugai has aggressively conducted R&D activities for prescription drugs as a key member of the Roche Group, both in Japan and overseas. Focusing particularly on the three areas of oncology, renal diseases and bone and joints diseases, Chugai aims to discover innovative drugs for both the Japanese and global markets.
A more detailed overview of Chugai’s businesses is provided in the annual report.
- Q05Tell me about Chugai’s R&D.
Chugai’s Research Division undertakes drug-discovery, focusing particularly on five strategic areas: oncology, renal diseases, bone and joint diseases, diabetes, and infectious diseases. Our research organization aims not just to achieve quantitative productivity—the discovery of a certain number of new compounds in a given period—but also to enhance our ability to create innovative medicines over time. To do this, we must increasingly be aware of -and where possible anticipate—developments that may affect the healthcare environment in which new medicines will be used. Accordingly, it is important to consider how existing therapies, the pharmaceutical market environment, the economics of healthcare, and other factors may evolve in the next 10 years. Our overriding goal is to continue developing innovative new therapies that address unmet medical needs and enhance patient well-being and quality of life.
To view our latest development pipeline, click the link below. Development status is updated quarterly in conjunction with financial reporting.
- Q06Can you provide an overview of your parent company, Roche?
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in-vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit the Roche website www.roche.com.
- Q07What is Chugai doing in terms of corporate governance?
Chugai is committed to continuously increase corporate value and respond appropriately and fairly to the requests of shareholders and other stakeholders. To fulfill this commitment, we have positioned the enhancement of corporate governance as an important management task and are building a system that emphasizes prompt decision-making, clarification of executive responsibilities, and management transparency.
Based on these concepts, Chugai has taken measures to strengthen functions of the Board of Directors and speed up its decision-making, such as optimizing the number of directors, nominating outside directors to check management from the stakeholder viewpoint, and introducing an executive officer system that aims at clarifying executive responsibilities. Furthermore, aiming at accurately responding to changes in global business environment as well as ensuring business deployment with a proper corporate attitude, the Chugai International Council (CIC) has been formed with specialists from various fields inside and outside Japan to provide advice for the management. Going forward, the Company will further pursue sound management and promote swifter decision-making, clarification of executive responsibility and enhancement of management transparency.
For more details, please visit the following site.
- Q01What is Chugai’s basic policy on Sustainability?
Chugai’s mission centers on Sustainability. We are dedicated to the creation of innovative medical products and services for the benefit of the medical community and human health around the world. We are committed to creating innovative pharmaceuticals by strategically allocating resources in the pursuit of innovation. In particular, we are focusing on unmet medical needs, where treatments remain insufficient, despite the pronounced needs of patients and medical professionals. Contributing to the health of people all over the world is the Group’s ultimate social responsibility.
Moreover, the Group seeks to contribute to sustainable growth. To do so, Chugai is actively involved—globally and locally—in aggressively promoting measures to preserve the environment, such as those aimed at reducing global CO2 emissions.
More information on Chugai’s performance can be found at the following link.
- Q02How is Chugai working to prevent global warming?
Both our Mission Statement and Business Conduct Guidelines directly address protecting the global environment, and prevention of global warming is one of the most important aspect for environmental preservation.
The Chugai Group is taking concrete steps to prevent global warming. These include utilizing environment-friendly facilities, maximizing energy efficiency, adopting solar power, introducing hybrid vehicles throughout the fleet and purchasing Green Power Certificates.
More information on Chugai’s effort to reduce CO2 emissions can be found at the following link.
- Q03How does the Company protect animal welfare?
Research using laboratory animals to confirm the safety and efficacy of drugs is essential to the development of new pharmaceuticals that contribute dramatic improvements to human health.
In 1988, the Chugai Group established guidelines on how to treat laboratory animals in research. We have adhered to these ever since, conducting all animal testing in an ethical, scientifically sound manner. In periodically updating these guidelines, Chugai has consistently sought to apply practical ethical consideration to all animal testing in line with this basic philosophy: "Our animal experiments should be conducted with due attention to animal welfare along with scientific appropriateness. We will rear animals with affection, consider animal physiology, ecology and behavior, and take measures to minimize pain."
These Chugai initiatives have been evaluated by AAALAC International, a global independent evaluation organization. In 2007, the company obtained full accreditation as a result. Inspection by AAALAC International is repeated every three years, and Chugai will continue its efforts to ensure animal welfare.
More information on Chugai’s effort to protect animal welfare can be found at the following link.
- Q04What are some other ways in which Chugai is contributing to society?
Fully committed to being a good corporate citizen, the Chugai Group proactively advances social initiatives in line with its Business Conduct Guidelines. Some recent examples include sponsoring charity events, conducting activities to raise disease awareness, patient advocacy, donating patient transport vehicles to community welfare organizations, supporting teacher training, providing resources to sustain next-generation scientific technologies, and numerous local contributions conducted near the Company’s sites.
More information on Chugai’s effort to contribute to society can be found at the following link.
Financial Performance and Reporting
- Q01When does the Company’s fiscal year end?
- The company reports on a calendar-year basis with a fiscal year-end of December 31.
- Q02Where can I find information on the company’s recent performance?
- Quarterly results are available from the link below. The Events & Presentations website provides the schedule of results announcements.
- Q03Where can I find information on the company’s past performance?
- Financial statements (income, balance sheet and cash flows), product sales, and key financial indicators for the past five years are available on the website. Other financial materials are also available for download.
- Q04Does Chugai provide a forecast or earnings guidance?
- These appear in the quarterly financial statements. In the event that performance is expected to differ materially from the forecast, Chugai may issue a press release, which can be viewed from the news section. Chugai can also notify you of releases via E-mail Alerts and RSS feeds. Click here for convenient registration.
- Q05How is R&D investment changing?
- Research and development expenses for the past five years are available in the Income Statement section. Please click here to view them.
- Q06Can I find out what was covered in IR meetings and presentations?
- The presentation materials and webcast are provided on the website. Click here to view them.
- Q07How can I obtain IR materials?
- Various IR materials are posted on the website. Please click here to view them.
- Q08When will the next financial results be announced?
- Please check the Events & Presentations section for IR schedules.
- Q09Where can I find the Company’s latest news?
- The E-mail Alert service delivers the latest IR updates. We also provide RSS feeds.
- Q10How do I contact the IR team?
- You may contact us by phone, fax or online inquiries form. Please click here for details.
- Q01On which stock exchange is Chugai listed and what is the ticker code?
Chugai’s stock is listed on the first section of the Tokyo Stock Exchange under the code 4519.
Chugai’s stock was first listed on the Tokyo Stock Exchange in March 1956.
- Q02What is the minimum trading unit of Chugai shares?
- 100 shares.
- Q03When are the record dates for dividends?
- Shareholders of record on June 30 and December 31 will be eligible for interim and year-end dividends, respectively. Interim dividends are typically paid in early September, and year-end dividends are usually paid following the Annual General Meeting of shareholders in March.
- Q04When is the next Annual General Meeting of Shareholders?
- The Annual General Meeting of Shareholders is held in March, following the close of the fiscal year in December.
- Q05Is it possible to exercise a voting right via Internet?
- If you are unable to attend the meeting, you can exercise your voting rights in writing or via electromagnetic method (the Internet, etc.).
R&D activities against the new coronavirus (COVID-19)
Posted June 8, 2020
Updated December 18, 2020
- Q01Does Chugai conduct any clinical developments for COVID-19?
Currently, Chugai is engaged in the following R&D activities for COVID-19.
- Local clinical study to evaluate Actemra/RoActemra for the treatment of hospitalized patients with severe COVID-19 pneumonia
- Joint research on a therapeutic antibody to fight COVID-19 between Chugai Pharmabody Research, a research center of the Chugai Group in Singapore and the Agency for Science, Technology and Research (A*STAR) (pre-clinical study)
Under the initiative of Roche, in which Chugai has a strategic alliance, is currently conducting global phase 3 clinical trials of Actemra/RoActemra for COVID-19.
- COVACTA study
COVACTA is a double-blind, placebo-controlled phase III study evaluating the safety and efficacy of intravenous Actemra/RoActemra added to standard of care in adult patients hospitalised with severe COVID-19 pneumonia compared to placebo plus standard of care.
The results of the COVACTA study were announced in July 2020, stating that the primary endpoint was not met.
- REMDACTA study
REMDACTA is a two-armed global phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of Actemra/RoActemra plus remdesivir, versus placebo plus remdesivir in hospitalised adult patients with severe COVID-19 pneumonia.
- Q02Media often refer to Actemra as a treatment option of COVID-19. Could Actemra be administrated for the treatment of COVID-19 as same as remdesivir?
- The efficacy and safety of Actemra for COVID-19 have not be confirmed. Currently, Chugai is conducting a domestic single-arm phase III study to evaluate the efficacy and safety of Actemra/Roactemra plus standard of care for hospitalized patients with severe COVID-19 pneumonia.
- Q03What is the rate of severe COVID-19 pneumonia?
According to the Chinese Centers for Disease Control report, approximately 19% of total patients with COVID-19 developed severe pneumonia.* However, there are no statistical reports for Japanese patients who develop severe pneumonia, thus the ratio is still uncertain for Japanese patients.
- * Wang D, et al. JAMA. 2020;323:1061-1069. 2. Wu Z, et al. JAMA. 24 February 2020. doi:10.1001/jama.2020.2648
- Q04When will Actemra for COVID-19 be filed in Japan?
- As for the filing of the local study in Japan, it is scheduled in 2021.
Joint research on a therapeutic antibody against COVID-19 between CPR and A*STAR (Announced on May 8, 2020)
- Q05Is the antibody-drug against COVID-19, jointly researched by CPR and A*STAR, given prophylactically lika a vaccine? Or is it given as a therapeutic agent after infection?
- We expect that the antibody can be used for both treatment and prevention.
- Q06When will the antibody against COVID-19 be filed and launched?
- Currently, the antibody is in pre-clinical stage, and the clinical study has not started.
- Q07How long does it usually take for pre-clinical studies and subsequent clinical trials to be completed?
- Generally, it takes five to eight years in pre-clinical research and three to seven years in clinical trials conducted in humans to confirm the safety and efficacy of drugs.
License agreement for Chugai’s antibody engineering technologies with Elli Lilly and Company (Announced on May 15, 2020)
- Q08Chugai announced the license agreement for its antibody engineering technologies with Elli Lilly and Company to develop therapeutic drugs for COVID-19. Will Chugai be involved in the R&D activity?
- Chugai will not be involved in Lilly’s R&D activity. With this agreement, Lilly will receive the right to use Chugai’s antibody engineering technologies for their research activities to develop next-generation COVID-19 treatments and the rights for the development and marketing of therapeutic antibodies applying these technologies.
Chugai in-licenses Antibody Cocktail for COVID-19 developed by Regeneron (Announced on December 10, 2020)
- Q09What is an antibody cocktail (REGN-COV2)?
REGN-COV2 is a neutralizing antibody ‘cocktail’ or combination targeted specifically against SARS-CoV-2. It consists of two non-competing and virus-neutralizing antibodies (casirivima + imdevimab).
Currently multiple clinical trials for treatment and prevention against COVID-19 are ongoing.
- Q10What is the stage of development?
- The casirivimab and imdevimab antibody cocktail is currently being studied globally in a phase II/III clinical study for the treatment of patients with COVID-19 who require hospitalization, a phase II/III clinical study for the treatment of non-hospitalized patients with COVID-19, and a phase III clinical study for prevention of infection in COVID-19 household contacts. A phase III open-label clinical study for the treatment of patients with COVID-19 who require hospitalization is also ongoing in the U.K. (the ‘RECOVERY’ trial).
- Q11Will Chugai also conduct clinical developments for both treatment and prevention in Japan?
- The plan of clinical trials in Japan are currently under discussion and no details are confirmed.
- Q12What does the design of the clinical trials in Japan look like? When will these start?
- The plan of clinical trials in Japan are currently under discussion and no details are confirmed.
- Q13Has REGN-COV2 been approved in the US?
- In November 2020, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization for casirivimab and imdevimab for the treatment of certain high-risk, non-hospitalized patients with mild-to-moderate COVID-19.