As of January 24, 2022
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 nasal vaccine for COVID-19Development of a recombinant vaccine for COVID-19 (Updated on January 24, 2022)

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 is administered by adding an adjuvant (a substance that enhances the effect of the vaccine) after expressing and purifying the target antigen protein from 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.

 

The table below summarizes the trials being conducted for the practical application of genetically modified protein vaccines.

 

Trial outline of S-268019
 
Trial outline
Japanese Phase 1/2 clinical trial
The Phase 1/2 clinical trial is double-blind and placebo-controlled study to evaluate safety, tolerability and immunogenicity of two doses of the vaccine. 60 adults are enrolled in the trial. For more information about this clinical trial, please refer to jRCT No.:2031210269. Subject registration for this trial has been completed. In the evaluation up to 28 days of two doses of the vaccine, confirmed tolerability and safety, neutralizing antibody titer equal to or higher than that of convalescent serum.
Japanese Phase 2/3 clinical trial
The Phase 2/3 clinical trial is a open-label study to evaluate safety, tolerability and immunogenicity of s-268019 in 3,100 adults and elderly people. For more information about this clinical trial, please refer to jRCT No.:2031210383. Subject registration for this trial has been completed.
Phase 3 additional dose clinical trial
This clinical trial is a randomized, active controlled, double-blind trial. In this trial, the efficacy and safety of an additional dose of Comirnaty or S-268019 in 200 adults, 6 months or more after receiving a primary series of Comirnaty, will be compared. For more information about this clinical trial, please refer to jRCT No.:2031210470. Subject registration for this trial has been completed.
Neutralizing Antibody Comparative Clinical Trial
This clinical trial is a double-blind randomized active controlled trial to evaluate a neutralizing antibody titer after the primary series of Vaxzevria or S-268019 in 1,000 adults and the elderly people.For more information about this clinical trial, please refer to jRCT No.: 2051210151.
global Phase 3 placebo-controlled onset prevention trial
This clinical trial is a randomized, placebo-controlled, double-blind trial to evaluate the onset prevention effect for COVID-19 after primary series of S-268019 compared with placebo. Approximately 50,000 adults and the elderly people will be enrolled and randomly assigned 2:1 to S-268019 and placebo.

We will continue to consult closely with the Ministry of Health, Labor and Welfare, Pharmaceuticals and Medical Devices Agency (PMDA) and other organizations based on the results of these clinical trials currently underway and regarding application for approval.

 

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 we will continue to establish a Supply system for more than 30 million people annually.With the goal, we will continue to promote efforts aimed at the early provision of Japanese vaccines In cooperation with related ministries and agencies.

* Baculovirus Expression Vector System

  • Development of a nasal vaccine for COVID-19

    Shionogi had signed a license agreement with HanaVax inc., a drug-discovery venture company originating from the University of Tokyo, for development of novel nasal vaccine candidates for COVID-19 using HanaVax’s cationic nanogel delivery system (cCHP). cCHP is HanaVax's unique delivery technology using cationic cholesteryl group-bearing pullulan. Currently, we are working on  research with the aim of initiating to phase 1 clinical trial in 2022. When administered intranasally, it can effectively induce immunity in the respiratory mucosa, and the whole body, without the pain caused by conventional injections. In countries where the medical environment is not well established, it may be difficult to administer vaccines by injection, and from the viewpoint of medical access, there is an expectation for a nasal vaccine as an easy-to-use preparation globally.

Discovery of novel therapeutic drugs

Discovery of novel therapeutic drugs
  • Discovery of novel antivirus drug (Updated on January 24, 2022)

    Shionogi discovered a small molecule oral antiviral drug (S-217622) which is 3CL protease inhibiter that selectively inhibits the enzyme essential for virus through vigorous collaborative research with the Hokkaido University Research Center for Zoonosis Control. S-217622 has demonstrated that the viral load is rapidly and significantly reduced in non-clinical trials using SARS-CoV-2 infected animals. According to the company's preliminary data, Shionogi confirmed high antiviral activity against the Omicron variant similar to other existing variants.

    In a Japanese phase1 clinical trial started in July 2021, we confirmed tolerability and no major safety problems, and the pharmacokinetic analyses confirm that blood drug concentrations meeting or exceeding the target concentration are achieved. Based on this trial result, a Japanese phase 2/3 clinical trial was started on September 27, 2021. The phase 2/3 clinical trial will evaluate the efficacy and safety of oral administration of this drug once daily for 5 days in mild, moderate, or asymptomatic COVID-19 patients, in comparison with placebo.  As of January 20, 2022, the antiviral effect was confirmed in Phase 2a Part of the Phase 2/3 clinical trial. Phase 2b / 3 Part is currently underway, and we are working to accelerate the accumulation of cases by completing the prescribed procedures for opening clinical trial sites not only in Japan but also in South Korea, Singapore, Vietnam, etc.

    As expressed in the related notifications1, 2, Shionogi has been consulting with PMDA from the early stages of S-217622 development. We have already been submitting non-clinical and manufacturing / CMC3.data. Shionogi submitted the Phase 1 clinical trials data and initiated to discuss how to submit the Phase 2/3 clinical trial data.

    Regarding the supply system, we are making good progress toward the completion of domestic supply preparation, because we were preparing in parallel with the clinical trials. We will continue to consult closely with the Ministry of Health, Labor and Welfare, PMDA and other organizations regarding future aspects of the submission timing, and promote initiatives aimed at the early provision of S-217622.

    We are also in talks with overseas regulatory agencies such as the FDA and EMA regarding global development. Partnering for global expansion is under negotiation with multiple companies.

    Furthermore, we are continuing our discovery efforts, using various modalities, including small molecules, peptides, and antibodies. Among them, we succeeded in creating COVID-19 candidates using PDPS (Peptide Discovery Platform System). We will strengthen the preparations for next pandemics, not only for the novel coronavirus, but also for other coronaviruses.

     

    1. Handling of drugs for approval examination for COVID-19

    2. Handling of drugs for approval examination for COVID-19 (ver.2)

    3. CMC:Chemistry Manufacturing and Control

Development and supply of diagnostic products

Development and supply of diagnostic products
  • Sales of novel coronavirus antigen test kit products

    Shionogi has concluded a joint sales agreement with Towns Co., Ltd. for novel coronavirus (SARS-CoV-2) antigen test kit products, and from November 29th, Shionogi started joint sales of "Immunoace ® SARS-CoV-2 II". This kit can easily obtain results in a short time of about 15 minutes with a nasopharyngeal swab or a nasal swab. In the future, both companies also will promote an antigen test kit capable of detecting both SARS-CoV-2 and influenza simultaneously, which Towns has currently filed for approval. Shionogi will provide products that meet the needs of medical institutions and patients. 

  • Online sales of novel coronavirus PCR detecting service

    Shionogi Healthcare's Online Shop has started offering a PCR test service that enables home-based tests, online medical examinations, and cooperation with health centers in November 29th. It is also compatible with mutant viruses, and it is possible to issue a publicly valid negative certificate. Shionogi will work towards total care for infectious diseases.

  • 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.

  • 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. After the launch, we are also engaged in clinical research to build evidence.

  • 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. On the other hand, in consideration of the balance of other test methods such as PCR and antigen test, we have stopped the efforts to commercialize the SATIC method for COVID-19. Basic research will continue in academia, and we will continue to hold the license right for the SATIC method.

  • 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.

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 clinical trial 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. 

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. Currently, we are expanding our services by concluding contracts with multiple local governments. 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.

  • Launch of mutational analysis service

    Shionogi launched mutational analysis services to detect the development and spread of variants in the target area, in addition to quantitative measurement service of inflow to municipal sewage treatment plants. This technology can detect not only existing variants, such as the Alpha and Delta, but also the Omicron variant, which was designated as the most alarming ‘variant of concern2’ by the World Health Organization (WHO) on November 26, 2021.

  • 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 : April 15th to April 28th, 2021
    Dispatched employees :
             30 people were dispatched to 12 health centers in Osaka Prefecture

     

    Dispatch period : August 18th to August 31st, 2021
    Dispatched employees :
             24people were dispatched to 9health 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

Press release regarding action for COVID-19

38.     Press release on January 20, 2021
Notice Regarding the Progress of S-217622 to Fight COVID-19

37.     Press release on January 17, 2021
Notice Regarding the Initiation of an Active Control Neutralizing Antibody Comparative Clinical Trial for COVID-19 Recombinant Protein-based Vaccine, S-268019 in Japan 

36.     Press release on January 5, 2021
Shionogi Announces Commitment to Fight COVID-19

35.     Press release on December 27, 2021
Notice Regarding the Initiation of a Global Phase 3 Clinical Trial for COVID-19 Recombinant Protein-based Vaccine, S-268019

34.     Press release on December 20, 2021
Shionogi Announces Commitment to Address the Omicron Variant of SARS-CoV-2

33.     Press release on December 7, 2021
Shionogi Announces Launch of Mutational Analysis Services for Wastewater-based Epidemiological Surveillance of the Novel Coronavirus

32.     Press release on December 3, 2021
Notice Regarding an Initiation of a Additional Dose Clinical Trial for COVID-19 Recombinant-based Vaccine

31.     Press release on November 29, 2021
Shionogi Announces Agreement for Joint Sales with Towns Co., Ltd. for Novel Coronavirus Antigen Test Kit Products in Japan.

30.     Press release on October 21, 2021
Shionogi Presents COVID-19 Therapeutic Agent Results at the ISIRV-WHO Virtual Conference

29.     Press release on October 21, 2021
Notice Regarding the Progress of Phase 2/3 Clinical Trial for New Formulation of COVID-19 Recombinant Protein-based Vaccine

28.     Press release on September 28,2021
Notice Regarding the Initiation of a Phase 2/3 Clinical Trial for a COVID-19 Therapeutic Agent in Japan

27.     Press release on August 24, 2021
Notice Regarding the Progress of Phase 1/2 Clinical Trial for New Formulation of COVID-19 Recombinant Protein-based Vaccine

26.     Press release on July 26, 2021
Notice Regarding the Initiation of a Phase 1 Clinical Trial for a COVID-19 Therapeutic Agent in Japan

25.     Press release on July 19, 2021
Shionogi and HanaVax Enter into a License Agreement for COVID-19 Vaccine Development Using Cationic Nanogel Delivery System

24.     Press release on June 14, 2021
SHIONOGI Announces the Start of the Wastewater Epidemiological Surveillance Service for the Novel Coronavirus in Japan

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

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

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

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

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

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

17.     Press release on April 14, 2021
Wastewater surveillance to monitor COVID-19 starts in Osaka Prefecture

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

15.     Press release on March 19, 2021
Establishing an Automated System for the Analysis of SARS-CoV-2 in Wastewater

14.     Press release on February 22, 2021
Dispatch employees to health centers in areas where new coronavirus infections have spread

13.     Press release on January 26, 2021
Shionogi and BioAge conclude a license agreement aimed at treating COVID-19

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

11.     Press release on December 16, 2020
Notice Regarding an Initiation of Phase 1/2 Clinical Trial for COVID-19 Recombinant Protein-based Vaccine

10.     Presentation material on October 30, 2020
1st Half of Fiscal 2020 Financial Results (Press Conference)

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

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

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

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

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

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

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

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

 

  Trial outline
Japanese Phase 1/2 clinical trial The Phase 1/2 clinical trial is double-blind and placebo-controlled study to evaluate safety, tolerability and immunogenicity of two doses of the vaccine. 60 adults are enrolled in the trial. For more information about this clinical trial, please refer to jRCT No.:2031210269. Subject registration for this trial has been completed. In the evaluation up to 28 days of two doses of the vaccine, confirmed tolerability and safety, neutralizing antibody titer equal to or higher than that of convalescent serum.
Japanese Phase 2/3 clinical trial The Phase 2/3 clinical trial is a open-label study to evaluate safety, tolerability and immunogenicity of s-268019 in 3,100 adults and elderly people. For more information about this clinical trial, please refer to jRCT No.:2031210383. Subject registration for this trial has been completed.
Phase 3 additional dose clinical trial This clinical trial is a randomized, active controlled, double-blind trial. In this trial, the efficacy and safety of an additional dose of Comirnaty or S-268019 in 200 adults, 6 months or more after receiving a primary series of Comirnaty, will be compared. For more information about this clinical trial, please refer to jRCT No.:2031210470. Subject registration for this trial has been completed.
Neutralizing Antibody Comparative Clinical Trial This clinical trial is a double-blind randomized active controlled trial to evaluate a neutralizing antibody titer after the primary series of Vaxzevria or S-268019 in 1,000 adults and the elderly people.For more information about this clinical trial, please refer to jRCT No.: 2051210151.
global Phase 3 placebo-controlled onset prevention trial This clinical trial is a randomized, placebo-controlled, double-blind trial to evaluate the onset prevention effect for COVID-19 after primary series of S-268019 compared with placebo. Approximately 50,000 adults and the elderly people will be enrolled and randomly assigned 2:1 to S-268019 and placebo.