As of June 14, 2021
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. 

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.

Development of prevention vaccine

Development of prevention vaccine
  • Development of a recombinant vaccine for COVID-19

    In collaboration with the National Institute of Infectious Diseases and Kyusyu University (the person who is in charge of this research has moved to Kyoto University), 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. As of February 1, 2021 (FY2020 Q3 financial results), there are no major safety concerns. We are in discussion with regulatory authorities to start Phase 3 trials, considering further plans.

     

    In addition, we are optimizing our manufacturing methods for large-scale production as well as equipping and expanding production facilities. In collaboration with UNIGEN Inc. (antigen production) and Api Co., Ltd. (formulated production manufacturing), the first phase of construction was completed at the end of March 2021, and the manufacturing equipment was completed. With the goal of producing sufficient vaccine for more than 30 million people by the end of 2021, we will expand our production facilities furthermore.

     

    We will continue to work with related ministries and agencies to promote initiatives aimed at the early provision of Japanese vaccines.

    * Baculovirus Expression Vector System

Development and supply of diagnostic products

Development and supply of diagnostic products
  • Joint sales of novel antigen test agent and dedicated measuring device

    On May 24, 2021, Shionogi and Lumira Diagnostics Japan Co., Ltd. have started joint sales of SARS-CoV-2 antigen test agent "Lumira SARS-CoV-2 Ag test strip" and "Lumira measuring device". This test agent and measuring device are also sold in the United States, Europe, etc. The LumiraDx SARS-CoV-2 Ag Test combines high-sensitivity results comparable to those from the PCR with speed and efficiency (results in less than 12 minutes) using samples from a nasopharyngeal swab or nasal swab.

  • Development of new rapid diagnostic method for viral infections (SATIC)

    Based on our license agreement for a new rapid diagnostic method for viral infections, including the novel coronavirus, 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. 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 the novel coronaviruses. As reagent reformulation requires several steps to confirm reaction performance and scalability, we have recently reassessed our projected initial launch timings, by the end of 2020.(At the moment, the start date of provision is not decided, but we are working on development assuming uses not only in medical institutions but also in various situations (airport quarantine office, inspection at event facility, etc.)

  • Marketing the IgG/IgM Antibody-test Kit

    We have marketed the IgG/IgM Antibody-test Kit for COVID-19 (20 test/kit) as a research reagent in Japan for epidemiological surveillance and assessment of the number of individuals previously infected with the novel coronavirus.

Discovery of novel therapeutic drugs

Discovery of novel therapeutic drugs
  • Discovery of novel antivirus drug

    Shionogi have been conducting nonclinical assessment to identify the best candidate compound against the novel coronavirus through collaborative research with the Hokkaido University Research Center for Zoonosis Control and the National Institutes of Biomedical Innovation, Health and Nutrition. However, we decided to revise our original plan 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 the novel coronavirus, but also for other coronaviruses, to prepare for potential future coronavirus pandemics, using various modalities, including small molecules, peptides, and antibodies

Prevention for COVID-19 exacerbation

Prevention for COVID-19 exacerbation
  • Development of asapiprant to control the aggravation

    Shionogi has concluded a license agreement with BioAge Labs, Inc. (hereafter "BioAge") to develop asapiprant (S-555739) to control the aggravation of COVID-19. Asapiprant is a DP1 receptor antagonist discovered by Shionogi. In a study conducted by BioAge, administration of asapiprant in aged mice infected with SARS-CoV-2 significantly decreased the mortality rate and viral load in the lungs. Several non-clinical studies and clinical trials in over 2,400 subjects have shown that asapiprant has high affinity and selectivity for the DP1 receptor and is well tolerated and safe.

    Based on the favorable results of non-clinical studies, BioAge has initiated a Phase 2 clinical trial in older patients with COVID-19. Shionogi is supporting BioAge's rapid initiation of the clinical trial by supplying investigational drugs and cooperating with the IND application to the US FDA. 

  • Sales of Th2 chemokine TARC kit for assisting in predicting exacerbation

    “HISCL® TARC Assay Kit", a Th2 chemokine (TARC) kit, is marketed as an auxiliary for assessment of aggravation risk in patients who have tested positive for SARS-CoV-2. The kit was developed jointly by Shionogi and Sysmex Corporation.

    Through the latest clinical research, the National Center for Global Health and Medicine has identified TARC, which is a useful biomarker for predicting the aggravation of COVID-19 patients from an early stage with a single measurement. It has been confirmed that the serum level of TARC remain low value in patients with severe symptoms of COVID-19 from early onset to aggravation. The test kit is expected to identify patients with a high risk of aggravation from the early stage of COVID-19 onset and it will be possible to follow up them intensively. It means helping to solve medical problems. It would contribute to effective utilization of medical resources, relief of medical system overwhelmed by increasing number of people receiving medical treatment, and reduce the risk of future medical collapse. 

Presymptomatic phase/ detection

Presymptomatic phase/ detection
  • Providing wastewater epidemiological surveillance service

    Shionogi has started wastewater epidemiological surveillance service which is a service to monitor the spread of novel coronavirus (SARS-CoV-2) in communities by measuring the concentration of traces of the virus in wastewater through the use of wastewater-based epidemiologic techniques. This service uses a highly sensitive detection system (patent pending) that we have developed jointly with Hokkaido University. By measuring the traces of the virus in wastewater, it is possible to assess, in an unbiased manner, the prevalence of SARS-CoV-2 infections in a community. If you need more information about this service, please refer “Wastewater-based Epidemiology Surveillance Service page” of our website.

  • Basic Agreement of Business Partnership for Wastewater Surveillance for Viruses in the Field of Infectious Diseases, Including Novel Coronavirus

    Shionogi had signed a basic agreement with Shimadzu Corporation regarding a business alliance of wastewater monitoring in the field of infectious diseases, including SARS-CoV-2. Based on this agreement, Shimadzu and Shionogi will proceed with discussions on the establishment of a consortium for the early social implementation of wastewater monitoring and the establishment of an All Japan system.

Support and contribution to local governments

  • Dispatch employees to the health centers in Osaka and Tokyo

    Shionogi has agreed with Osaka and Tokyo prefecture to dispatch employees to the health centers in areas where the burden on the medical system and health centers had increased in order to deal with the rapidly increasing number of infected people, to support COVID-19 epidemic prevention activities. They assisted public health nurses in mainly peripheral work including data entry of patient outbreak information, preparation and sending of documents such as work restriction notifications and inspection requests, and logistics support for epidemiological investigations such as telephone interviews.

     

    Support results】 

    Dispatch period : February 22nd to March 31st, 2021
    Dispatched employees :
             18 people were dispatched to 9 health centers in Osaka Prefecture
              4 people were dispatched to 4 health centers in Tokyo

     

    Dispatch period : February 22nd to March 31st, 2021
    Dispatched employees :
             30 people were dispatched to 12 health centers in Osaka Prefecture

  • 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.

  • 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 in May, 2020, 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.

  • 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)

13. Press release on January 26, 2021

Shionogi and BioAge conclude a license agreement aimed at treating COVID-19

14. Press release on February 22, 2021

Dispatch employees to health centers in areas where new coronavirus infections have spread

15. Press release on March 19, 2021

Establishing an Automated System for the Analysis of SARS-CoV-2 in Wastewater

16. Press release on March 23, 2021

Notice regarding an initiation of Phase 2 clinical trial by BioAge aimed at treating older patients of COVID-19

17. Press release on April 14, 2021

Wastewater surveillance to monitor COVID-19 starts in Osaka Prefecture

18. Press release on April 16, 2021

Shionogi Announces Agreement of Joint Sales with LumiraDx Japan Co., Ltd. for Novel Coronavirus Antigen test agent “LumiraDx SARS-CoV-2 Ag Test Strip” and diagnostic instrument in Japan

19. Press release on April 26, 2021

Shionogi Filed the Application for Marketing Approval of Th2 Chemokine TARC Kit "HISCL® TARC reagent" to Assist in Predicting the Exacerbation of COVID-19

20. Press release on May 24, 2021

Shionogi Announces Novel Coronavirus Antigen test agent “LumiraDx SARS-CoV-2 Ag Test Strip” and diagnostic instrument launched in Japan

21. Press release on June 2, 2021

Notice Regarding the Signing of Basic Agreement of Business Partnership between SHIMADZU and SHIONOGI for Wastewater Surveillance for Viruses in the Field of Infectious Diseases, Including Novel Coronavirus

22. Press release on June 7, 2021

Th2 Chemokine TARC Kit "HISCL® TARC Assay Kit" is Approved for an Additional Indication as an Auxiliary for Assessment of COVID-19 Aggravation risk

23. Press release on June 11, 2021

Notice Regarding an Exclusive license Agreement for a Sensitive Virus Detection Method of Viruses and Bacteria, Including Novel Coronavirus, between Hokkaido University and SHIONOGI

24.. Press release on June 14, 2021

SHIONOGI Announces the Start of the Wastewater Epidemiological Surveillance Service for the Novel Coronavirus in Japan