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BioNTech and Fosun Pharma Receive Special Import Authorization in Macau for COVID-19 mRNA Vaccine

02-25 2021
MAINZ, GERMANY, and SHANGHAI, CHINA, 25 February 2021 — BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK) today announced that the COVID-19 mRNA vaccine COMIRNATY® (also known as BNT162b2, Chinese product name: 復必泰TM) has received Special Import Authorization granted by the Health Bureau of Macau Special Administrative Region of the PRC (“Macau”) for the use of the local COVID-19 vaccination program, of which the limit amount is 105,000 doses.

Macau plans to purchase a total of 400,000 doses (including the 105,000 doses granted the Special Import Authorization) COVID-19 mRNA vaccine BNT162b2 for the local COVID-19 vaccination program. The rest of the procurement in addition to the Special Import Authorization, will be in accordance with the needs of the Macau government's COVID-19 vaccination program on re-application and approval.

“With the support from the Macau SAR government, we reached another important milestone in Greater China for the COVID-19 mRNA vaccine co-developed by BioNTech and Fosun Pharma.” Wu Yifang, Chairman and CEO of Fosun Pharma said. “We are working to deliver our vaccines to Macau as soon as possible, in order to help Macau to consolidate the gains of success pandemic control and to protect the health of millions of households in the region.”

On 16 March 2020, BioNTech and Fosun Pharma announced a strategic collaboration to work jointly on the development and commercialization of a COVID-19 vaccine product in Greater China based on BioNTech’s proprietary mRNA technology platform.

“The Special Import Authorization granted in Macau marks another step forward on our path to delivering a safe and efficacious vaccine to the global population,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “This joint development effort with our partner, Fosun Pharma, is a testament to the importance of global cooperation to help address the pandemic.”

According to the data from the global Phase 3 Clinical trial, BioNTech’s mRNA-based COVID-19 vaccine met all primary efficacy endpoints, demonstrating effectiveness of 95% in preventing COVID-19 in adults and 94% in adults over 65 years of age. Efficacy in the trial was consistent across age, gender, race and ethnicity. This COVID-19 mRNA vaccine has been granted Authorization for Emergency Use in Hong Kong on 25 January 2021 and has been authorized for use by the health regulatory authorities of over 50 countries and regions, including the United Kingdom, the United States, Canada, and the European Union.

COMIRNATY® is a COVID-19 vaccine which is based on messenger RNA, a natural molecule that acts like a blueprint providing instructions for human cells to make a target protein, or antigen, which activates the body’s immune response against the respective virus. mRNA vaccines utilize the genetic sequencing of the virus but not the virus itself. Therefore, mRNA vaccine has no viral component and no risk of infection. Also, mRNA vaccine has advantages such as short development cycle, enabling rapid development of novel vaccine candidates to meet viral mutations; the dual mechanism of humoral and T-cell immunity is immunogenic and does not require adjuvants; it is easy to mass-produce and supports the goal of global supply. 
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