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.

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  • 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.

    So far, Shionogi has continuously conducted immunogenicity tests in mice in collaboration with the National Institute of Infectious Diseases (NIID) to examine the multiple candidate antigen proteins produced by Shionogi and our collaborative research partner, Kyushu University (Dr. Hashiguchi who is in charge of this research has moved to Kyoto University) including candidate adjuvants**. In these tests, we have selected the combination of antigen protein and adjuvant that induces an increase of antigen-specific IgG antibody titer and virus neutralization activity. Currently, we are undertaking non-clinical safety studies and pharmacological studies to support the preventive effects which are required for starting clinical trials. We will promptly carry out these non-clinical studies toward the start of clinical trials within 2020, and will continue to discuss the clinical trials necessary for confirming enough safety and efficacy in humans with the Ministry of Health, Labor and Welfare and Pharmaceuticals and Medical Devices Agency (PMDA). In addition, with the goal of producing vaccines for more than 30 million people by the end of 2021, we will accelerate the institution of manufacturing and scale-up methods as well as the construction and expansion of production facilities.

     

    * Baculovirus Expression Vector System

    ** Substance that fortifies vaccine efficacy by activating immunity

  • Commitment to the discovery of novel therapeutic drugs

    Shionogi has identified the follow-up compounds synthesized based on the promising lead compounds against SARS-CoV-2 found through a collaborative research with the Hokkaido University Research Center for Zoonosis Control. We have been conducting exploratory assessments, such as safety and drug efficacy, on the follow-up compounds sequentially and the manufacturing process of the most promising candidate had already been investigated at this time. Now we are preparing to start non-clinical studies immediately after the best candidate has been identified. We will continue to focus on our drug discovery efforts with the aim of starting clinical trials in FY2020. 

  • Commitment to the development of diagnostic products

    Based on a license agreement regarding a new rapid diagnostic method for viruses including SARS-CoV-2 with Nihon University, Gunma University, and Tokyo Medical University 7, Shionogi is pursuing the practical development of a new rapid diagnostic method for COVID-19, using an innovative nucleic acid amplification technique, SATIC (signal amplification by ternary initiation complexes) method. The SATIC method enables a determination of presence or absence of SARS-CoV-2 infection visually without a detector. Virus determination can be made in about 25 minutes after sample collection. Furthermore, this method has competitive features which enable viral detection from saliva and sputum collected reliably and safely with high sensitivity equivalent to that of a PCR method. Shionogi is preparing an application for approval as in-vitro diagnostic drug and striving for commercialization. With various assays, such as antigen kits, being released recently, we believe that it is necessary to ensure a supply count of more than a certain level in order to meet the needs of medical institutions by taking advantage of the characteristics of this technology. It is therefore we decided to revise our initial target for the launch of early-stage products from September 2020 to December 2020 and focus on establishing a supply system. Since it is necessary to mix and prepare multiple reagents at the time of use for the initial type of the product, Shionogi will accelerate product development and its scale-up studies for early provision of kits that enable easier and quicker diagnosis of multiple samples, so that they can be widely used by general medical institutions, etc.

     

    We have marketed the IgG/IgM Antibody-test Kit for COVID-19 as a research reagent in Japan since June 3, 2020 to be useful for epidemiological surveillance and studies of SARS-CoV-2/COVID-19 aiming to determine the number of individuals previously infected with SARS-CoV-2 . In order to improve convenience, we have changed the product standards from the original 50 test/kit to the 20 test/kit.

  • 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)

 

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