Commitment to Fight COVID-19

We would like to convey our sincere condolences to those who have lost their lives to the Coronavirus Disease COVID-19. Shionogi sincerely wish for the speedy recovery of all those persons affected by this disease.

With continued social disruption caused by the worldwide spread of the novel coronavirus (SARS-CoV-2), Shionogi continues our intensive efforts to deliver pharmaceutical products to patients in need in a reliable and stable manner. As a pharmaceutical company with a major focus on infectious diseases, Shionogi is also working with public institutions, academia, and partner companies to address COVID-19, by pursuing the discovery of novel therapeutics and the development of vaccine and diagnostic product. As a progress of the manufacturing of prophylactic vaccines, Shionogi today announces our project was adopted by the Ministry of Health, Labour and Welfare as a public recruitment project for “The Urgent Improvement of Vaccine Production Systems, etc.”. We also inform current situations of our efforts to fight COVID-19.

Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” as our key focus. We are not limiting ourselves to the research and development of therapeutic medications, but are also focused on the total care of infectious disease, through awareness building, prevention, diagnosis, and treating exacerbations, as well as the infection itself. We will continue to strive to fulfill our social responsibility and to contribute to re-establishing the safety and security of society by bringing forward new tools and technologies for the diagnosis and subsequent treatment of COVID-19 to support early containment of the pandemic. Shionogi will work closely with government, industry, and academia to accelerate our efforts and will keep all stakeholders informed regarding the progress of our efforts.

image
  • Commitment to the vaccine development

    Shionogi is pursuing the discovery and development of a recombinant protein vaccine for COVID-19, using a unique technology, “BEVS*” of UMN Pharma Inc., a subsidiary of Shionogi. The recombinant protein vaccine contains the target antigen protein manufactured based on the genetic information of the virus. Compared to novel technologies such as mRNA vaccines, by which the target antigen protein is synthesized in the body, the recombinant protein vaccine needs a certain development period for antigen expression and purification before initiating dosing trials. However, the recombinant protein vaccine is manufactured based on an established technology and several vaccines such as influenza prophylactic vaccine utilizing BEVS have been approved and put to practical use based on its efficacy and safety.

    In December 2020, we initiated a Phase 1/2 clinical trial in Japan . For details, please refer to our press release dated December 16, 2020 and the Japan Registry of Clinical Trials website (jRCT2051200092).
    In addition, with the goal of producing sufficient vaccine for more than 30 million people by the end of 2021, we are optimizing our manufacturing methods for large-scale production as well as equipping and expanding production facilities.

     

    * Baculovirus Expression Vector System

  • Commitment to the discovery of novel therapeutic drugs

    Shionogi have been conducting nonclinical assessment to identify the best candidate compound against SARS-CoV-2 through collaborative research with the Hokkaido University Research Center for Zoonosis Control and the National Institutes of Biomedical Innovation, Health and Nutrition. However, as we announced on October 30, 2020 , we decided to revise our original plan (to start clinical trials in FY2020) because further efficacy and safety studies are required to assess the compound’s potential. Now we are assessing the efficacy and safety of this compound in detail to determine whether it is an optimal candidate for development. Furthermore, we are continuing our  discovery efforts, not only for SARS-CoV-2, but also for other coronaviruses, to prepare for potential future coronavirus pandemics, using various modalities, including small molecules, peptides, and antibodies.

  • Commitment to the development of diagnostic products

    Based on our license agreement for a new rapid diagnostic method for viral infections, including SARS-CoV-2, with Nihon University, Gunma University, and Tokyo Medical University, Shionogi is pursuing the development of a new rapid diagnostic method for COVID-19, using an innovative nucleic acid amplification technique, the SATIC (signal amplification by ternary initiation complexes) method. We are seeking to commercialize, as soon as possible, an in-vitro diagnostic test for SARS-CoV-2 utilizing the unique approach and superior properties of the SATIC method. After internal testing, we decided that some of the component reagents need to be improved to achieve higher sensitivity and stability of the response to SARS-CoV-2 viruses. As reagent reformulation requires several steps to confirm reaction performance and scalability, we have recently reassessed our projected initial lauch timings. In parallel, we are accelerating the development of a new kit form that would be easier and quicker to use, particularly for multiple samples, and which could be efficiently deployed by general medical institutions, etc.

     

    We have marketed the IgG/IgM Antibody-test Kit for COVID-19 (20 test/kit) as a research reagent in Japan since June 3, 2020 for epidemiological surveillance and assessment of the number of individuals previously infected with SARS-CoV-2.

  • Initiatives for business continuity

    Shionogi has set up “Coronavirus Response Headquarter” before declaration of a state of emergency and has promoted decision making across the entire company.  Although the headquarter were dissolved due to the cancellation of the declaration, each business unit is dealing with internal and external correspondence in the post-corona. Under the declaration of a state of emergency, we have improved the environment of work-at-home and many of the employees basically moved to work from home. On the other hand, we have formulated and implemented a Business Continuity Plan (BCP) that requires a response by coming to work. The personnel identified in the plan will carry out private car commuting and staggered working hours to prevent the spread of infection not only to themselves but also to the whole society. As a result, we continued our business, which is our responsibility as a pharmaceutical company, such as stable drug supply and research on Covid-19.

    In the future, we will continue to carry out necessary business activities to stakeholders while striving to prevent the spread of infections in a work style that corresponds to the “new lifestyle” by implementing various measures such as working from home and staggered working hours. We will fulfill my responsibility.

  • Initiatives for Stable Supply of Drugs

    Based on our philosophy "Shionogi strives constantly to supply the best medicine to protect the health and wellbeing of the patients we serve", in order to ensure that the necessary medicines can be delivered to patients, we thoroughly implement employee infection prevention, physical condition management, and temperature measurement system, and make every effort to ensure a stable supply. 

  • Alignment with International Societies

    We posted a video message to the United Nations Global Compact "#Uniting Business to Respond to COVID-19" campaign that is being conducted in collaboration with the United Nations . As a pharmaceutical company specializing in the field of infectious diseases, Our CEO Dr. Teshirogi introduce our efforts towards COVID-19, such as the development of therapeutic drugs and vaccines, and declared to work closely with the international community to overcome this global threat.

     

For your Reference

Press release regarding action for COVID-19

1.      Press release on March 17, 2020
Business Partnership with Micro Blood Science Inc. for an IgG/IgM Antibody-test Kit for COVID-19

2.      Press release on April 14, 2020
Shionogi Announces Commitment to Fight COVID-19

3.      Press release on April 27, 2020
Notice Regarding a Development Decision of Vaccine for COVID-19

4.      Press release on June 3, 2020
IgG/IgM Antibody-test Kit for COVID-19 launched in Japan

5.      Press release on June 3, 2020
Shionogi Announces Commitment to Fight COVID-19 (2)

6.      Press release on June 19, 2020
Shionogi Announces Commitment to Fight COVID-19 (3)

7.      Press release on June 22, 2020
Business Partnership with Nihon University, Gunma University, and Tokyo Medical University for a Rapid Diagnostic Methods for Viruses in the Field of Infectious Diseases, Including Novel Coronavirus

8.      Press release on August 7, 2020
Shionogi Announces Commitment to Fight COVID-19 (4)

9.      Press release on September 24, 2020
Shionogi Announces Commitment to Fight COVID-19 (5)

10.      Presentation material on October 30, 2020

1st Half of Fiscal 2020 Financial Results (Press Conference)

11.      Press release on December 16, 2020

Notice Regarding an Initiation of Phase 1/2 Clinical Trial for COVID-19 Recombinant Protein-based Vaccine

12.      Press release on December 18, 2020
Shionogi Announces Commitment to Fight COVID-19 (6)

 

In addition, there has been a considerable amount of valuable information on COVID-19 posted on other websites. The following official websites are recommended for your reference:

Information on the impact of the novel coronavirus on daily life:

・   Prime Minister’s Office of Japan: Useful Information on the Novel Coronavirus Disease (COVID-19)
http://japan.kantei.go.jp/ongoingtopics/coronavirus_info_e.html

Information related to disease caused by the novel coronavirus:

・   Cabinet Secretariat: The Novel Coronavirus Infection Control: (only in Japanese)
https://corona.go.jp/

・   MHLW: Ministry of Health, Labour and Welfare : About Coronavirus Disease 2019 (COVID-19)
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/newpage_00032.html

・   CDC: Centers for Disease Control and Prevention: Coronavirus Disease 2019 (COVID-19)
https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fsummary.html

・   WHO: World Health Organization: Coronavirus
https://www.who.int/health-topics/coronavirus#tab=tab_1