Daiichi Sankyo is promoting the R&D of vaccines and therapeutic agents targeting COVID-19 by leveraging the best use of our past and present research properties, technologies, and accumulated R&D knowledge and experience as an innovative pharmaceutical company, and also in collaboration with external institutions.

1-1. R&D of genetic (mRNA) vaccines

For the prevention of COVID-19, Daiichi Sankyo was participated in "Fundamental Research on the Control of a Novel Coronavirus (2019-nCoV*1)"*2 (Principal investigator: Prof. Yoshihiro Kawaoka, Institute of Medical Sciences, The University of Tokyo), which is an initiative supported by the Japan Agency for Medical Research and Development (AMED). In addition, using novel nucleic acid delivery technology*3 developed by Daiichi Sankyo itself, we initiated a basic research project on a genetic (mRNA) vaccine with the title "Development of a Genetic Vaccine for 2019-nCoV".

In June 2020, in a pharmacological evaluation of a prototype mRNA vaccine using animal models, we demonstrated an increase in antibody titers to the novel coronavirus. Based on this result, we set the development of this mRNA vaccine as one of our top priority projects and began to consider an increase in scale toward establishing a supply system. In March 2021, we commenced clinical study in Japan supported by the AMED’s “Development of vaccines for the novel coronavirus disease*4 (Second Round)".

Daiichi Sankyo plans to use the facilities of the “Pandemic Influenza Vaccine Development and Production System Development Project” to develop the supply system. With the aim of starting supply of COVID-19 vaccines in Japan as soon as possible, we will prioritize efforts toward establishing a production platform and ensuring a stable supply.

• *1 2019-nCoV is synonymous with SARS-CoV-2.
• *2 A vaccine development initiative determined for support by AMED under urgent government-wide efforts against the worldwide spread of COVID-19.
• *3 Technology focusing on forming lipid nanoparticle structures, stabilizing pharmaceutical active ingredients and delivering nucleic acids into immune cells. Compared to conventional vaccine technology, it has been demonstrated to induce a more optimal immune response.
• *4 The project aims to support the development of a vaccine against COVID-19, for which R&D is already underway, and aims to ensure the early commercialization of safe and effective vaccines.

1-2. Drug Repositioning

In addition to the aforementioned activities, Daiichi Sankyo is also conducting a "drug repositioning" to search for COVID-19 treatments in which we, in collaboration with academia and others, are not only evaluating the potential applications of our existing products for COVID-19 treatment but are also focusing on selecting potential target molecules and chemical compounds for COVID-19 therapeutics using the knowledge and experience of our past and current R&D projects.

Through this drug repositioning, Daiichi Sankyo aims to provide patients with a new treatment option for COVID-19.

2-1. Manufacturing and Supply of COVID-19 Vaccine

Daiichi Sankyo has started manufacturing the AstraZeneca COVID-19 vaccine (hereinafter, AZD1222) in Japan.

Based on the contract manufacturing agreement with AstraZeneca, Daiichi Sankyo is using undiluted solutions provided by AstraZeneca to manufacture AZD1222 in Japan, including vial filling, packaging.
The manufacture of AZD1222 is being undertaken by Daiichi Sankyo Biotech, a subsidiary of Daiichi Sankyo, at a “Pandemic Influenza Vaccine Development and Production System Development Project” facility.

The Japanese government has announced that it will supply to various countries and regions through COVAX*. In response to this announcement, a portion of the COVID-19 vaccine to be shipped from Daiichi Sankyo is provided to countries and regions including Southeast Asian countries through the Japanese Government.
As part of efforts towards ending the global COVID-19 pandemic, Daiichi Sankyo is striving to support regions in need of medical access through contract manufacture of the COVID-19 vaccine.

* COVAX is an international scheme led by the Gavi Vaccine Alliance, the Coalition for Epidemic Preparedness and Innovation (CEPI), and WHO to jointly purchase vaccines and distribute them to developing countries.

2-2. Continuous Supply and Delivery of Existing Products

We are taking necessary measures to ensure the supply and delivery of our products worldwide. To date, there has been no disruption to our supply chain or to the delivery of our medicines to the people who need them. Nevertheless, we will continue to closely monitor our supply chain situation for any changes.

As the safety of patients is our first priority, we are conducting clinical trials in close collaboration with our clinical trial investigators and CROs in light of the recent guidance from local health regulatory authorities and in consideration of the situations at study locations, and also taking into account heavy burden of the virus on primary care facilities and public health.

We have experienced temporary suspensions of new patient study enrollment in some studies due to conditions in local areas and the need to focus healthcare resources to combating the pandemic. Some of these trials have resumed to enroll new patients while others remain temporarily suspended.

We recognize this is a rapidly evolving situation and we will continue to adapt and provide timely updated guidance related to Daiichi Sankyo clinical research. In particular, we are working closely with our clinical trial investigators and other relevant personnel to help to assure everyone’s safety and allow continued trial treatments to participants.

In support of relief efforts for countermeasures against COVID-19, Daiichi Sankyo has made a donation of US $1 million to the COVID-19 Solidarity Response Fund for the World Health Organization (WHO) through the Japan Center for International Exchange. The COVID-19 Solidarity Response Fund was established to support the work of the WHO and is backed by the United Nations Foundation and the Swiss Philanthropy Foundation. This donation is part of Daiichi Sankyo’s global contribution to society in light of the need to support worldwide measures against COVID-19 and concerns about the rapid spread of infections in the future in areas where access to healthcare in inadequate.

Other Daiichi Sankyo group companies around the world have also already provided a variety of support, including donations, to meet specific needs in their own countries or regions.

Our U.S. affiliate, Daiichi Sankyo, Inc., has made donations totaling USD $645,000 to Healthcare Ready, Americares, the American Red Cross, and other local organizations with programs dedicated to addressing the COVID-19 pandemic. Furthermore, US employees with appropriate medical or healthcare credentials are allowed to take extra time away from work to volunteer their time to help alleviate the pressure on those on the healthcare front-lines who are taking care of patients.

Our European affiliates have supported a large number of local and regional organizations in the form of both financial and in-kind donations, including equipment for hospitals.

• In Germany, our European Headquarters, Daiichi Sankyo Europe GmbH, has made a donation of 100,000 euros to the city of Pfaffenhofen, near Munich, where one of our production sites is located. This money is earmarked for purchasing face protection masks. We also donated money to local food banks and to a welfare organization supporting refugees. In addition, to help support outdoor activities to reduce the risk of infections, we donated to a care facility for persons with disabilities for the purchase of bicycles and protective gear, which are also used to train children the useful life skill of learning to ride a bicycle with the cooperation of local police.
• In Italy, the company donated 40,000 euros to provide necessary medical equipment and sanitary products to medical institutions. A matching gift program for individual contributions by employees was also conducted, and the company has made an unconditional contribution to provide the new portal site named “COVID-19 and heart”, which supports healthcare professionals in the treatment of patients and was created on the initiative of IRCCS Multimedica. In addition and in cooperation with an Italian association, the company also sponsored the publication of an educational pamphlet to educate and protect elderly people against disinformation and fake news related to COVID-19, and the establishment of a telephone helpline for elderly people coping with the prolonged isolation.
• In Spain, the company donated 340,000 euros worth of urgently needed medical equipment to medical institutions.
• In Portugal as well as in the Netherlands, webinars focusing on cardiovascular risk patients and COVID-19 were organized.
• In Belgium, France, Ireland, Portugal and Turkey, Daiichi Sankyo group companies donated a total of 70,000 euros to healthcare institutions and associations.
• In Turkey, we conducted the "Silent Heroes" project to support measures against COVID-19. In this project, physicians, healthcare professionals, employees of Daiichi Sankyo Turkey, and prominent singers cooperated to reinterpret the folk note "Uzun İnce Yoldayım" (I am walking on a long and narrow path) to help raise public awareness of the struggle with COVID-19 while never forgetting to carry on with life. This effort was evaluated and selected as a "Prize for Social Responsibility 2020" by the Turkish Pharmaceutical Industry.

Daiichi Sankyo also made a donation of 1 million yuan through the Chinese Red Cross Association, in addition to a donation of medicine to primary care facilities in Wuhan City was made by a local group company, to support local responses to the virus outbreak in China in February 2020.

In Brazil, where infections are still expanding, we created an initiative called “CESTOU” in September 2020 to help people who had been more adversely affected by the pandemic due to their social vulnerability. Through this initiative, employees of Daiichi Sankyo Brasil selected and paid for food basket donations from their own pocket, and Daiichi Sankyo Brasil pledged to make a matching food basket donation for each one. From September to December 2020, Daiichi Sankyo Brazil donated 1,380 food baskets through 6 NGOs, and as of March 2021, they are continuously implementing this donation initiative.

In Asia outside of China, group companies donated a total of an equivalent of USD $28,000 to hospitals and organizations in Thailand and South Korea.

Details of further support by Daiichi Sankyo group companies worldwide will be made public on this page as they become available.

In our Tokyo HQ we have established an “Emergency Response Team” led directly by our CEO, Sunao Manabe. As a company we have taken numerous measures to prevent the spread of the infection, taking into consideration the views of the Japanese government, governments in countries where we have affiliates, and other experts.

In countries or regions where the infection rapidly expanded and/or is still pervasive, Daiichi Sankyo Group employees and contractors who are able to work from home are being proactively encouraged to do so. Given the nature of our work, it is not possible for everyone to work remotely. We share immense appreciation for our colleagues dedicated to ensuring the continuous and safe supply of our medicines who continue to serve our patients working hard in our manufacturing and packaging sites globally. We have still ceased face-to-face interactions with customers, healthcare providers, and other business associates as much as possible in addition to continuing to adhere to the extensive travel restrictions in the countries and regions mentioned above.

Our affiliates globally have also established a wide variety of supportive programs and activities to help our employees and consultants as we all navigate through this crisis.

COVID-19 Statement - DAIICHI SANKYO, INC.