07/12/2021 | Press release | Distributed by Public on 07/12/2021 01:32
SHANGHAI, CHINA and MAINZ, GERMANY, July 12, 2021 - BioNTech SE (Nasdaq: BNTX, 'BioNTech' or 'the Company') announced that Fosun Industrial Co., Limited ('Fosun Industrial'), a wholly owned subsidiary of its partner Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ('Fosun Pharma' or 'Group'; Stock Code: 600196.SH, 02196.HK), has reached advance procurement agreements for the mRNA-based COVID-19 vaccine BNT162b2 with Taiwan Semiconductor Manufacturing Co., Ltd. ('TSMC'), Hon Hai Precision Industry Co., Ltd. ('Hon Hai'), Yonglin Charity Foundation ('Yonglin') and Zuellig Pharma, Inc. ('Zuellig Pharma') respectively. Fosun Industrial will sell a total of 10 million doses of COVID-19 mRNA vaccines to Zuellig Pharma (pharmaceutical company with qualifications to import vaccines) entrusted by TSMC, Hon Hai and Yonglin. These COVID-19 mRNA vaccines will be donated to the relevant agency of disease control of the Taiwan region for local vaccination.
Ugur Sahin, M.D., CEO and Co-founder of BioNTech said, 'It has always been our goal to provide access to a well-tolerated and effective vaccine for as many people as possible worldwide. BioNTech is glad to be able to also supply the Taiwanese people with vaccines manufactured in the European Union. In parallel, BioNTech will continue to evaluate the vaccine for use against additional mutations of concerns.'
Wu Yifang, Chairman and CEO of Fosun Pharma said, 'We are glad to see that the vaccine co-developed by Fosun Pharma and BioNTech could play a positive role in the prevention and control of the epidemic in Taiwan. We will work closely with our partners to provide safe and effective vaccines to Taiwan at an early date, safeguarding the lives and health of Taiwan compatriots, and helping their life getting back on track as soon as possible.'
On 16 March 2020, BioNTech and Fosun Pharma announced a strategic collaboration. Fosun Pharma has been licensed by BioNTech to exclusively develop and commercialize COVID-19 vaccines based on its mRNA technology platform in Chinese Mainland, Hong Kong SAR, Macau SAR and Taiwan region.
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.
BioNTech Forward-looking Statements
This press release contains 'forward-looking statements' of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including a potential second booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT162b2 having a modified mRNA sequence; the collaboration between BioNTech and Fosun Pharma to develop and commercialize a potential COVID-19 vaccine; the potential of BNT162b2 for adolescents 12 to 15 years of age, evaluation of BNT162b2 in children 6 months to 11 years old, anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the risk that demand for any products may be reduced or no longer exist; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021; and challenges related to public vaccine confidence or awareness.
Any forward-looking statements in this press release are based on BioNTech's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required
About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ('Fosun Pharma'; stock code: 600196.SH, 02196.HK) is a leading global pharmaceutical and healthcare provider in China. Fosun Pharma strategically operates businesses in the pharmaceutical and health industry, including pharmaceutical manufacturing, medical devices and medical diagnosis, and healthcare services. Through its associated company Sinopharm Co., Ltd., Fosun Pharma's business extends to pharmaceutical distribution and retail.
Fosun Pharma takes pharmaceutical manufacturing as its core business and sticks to innovative research and development. Through in-house R&D, co-development, in-licensing and incubation, Fosun Pharma had established platforms for small molecule innovative drugs, antibody drugs and cell therapy, focusing on major therapeutic areas, including oncology, immunology, '4 hypers' (hypertension, hyperlipidemia, hyperglycemia and hyperuricemia) and their complications, as well as central nervous system. In the meantime, Fosun Pharma keeps close track of cutting-edge technologies, such as targeted protein degradation, RNA, oncolytic virus and gene therapy to enhance its innovation ability.
Looking forward, under guidance of 4IN strategy (Innovation, Internationalization, Integration and Intelligentization), Fosun Pharma practices innovation and transformation, integrated operation and steady development, as well as the concept of sustainable development. Fosun Pharma is committed to becoming the first-class enterprise in the global mainstream healthcare industry.
For more information, please visit: www.fosunpharma.com.
Forward-looking Statements of Fosun Pharma
This press release contains 'forward-looking statements' of Fosun Pharma. These forward-looking statements may include, but may not be limited to, statements concerning: Fosun Pharma's efforts to combat COVID-19; the collaboration between Fosun Pharma and BioNTech to develop a potential COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our clinical trial and/or in commercial use based on data observations to date; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or emergency use authorization; our contemplated shipping and storage plan; and if approved, the ability of BioNTech and Fosun Pharma to supply the quantities of BNT162b2 to meet market demands, including our production estimates for 2021. Any forward-looking statements in this press release are based on Fosun Pharma's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet the predefined endpoints in clinical trials, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; whether and when any other biologics license and/or emergency use authorization applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccine candidates; whether and when any applications that may be pending or filed for BNT162b2 may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's benefits outweigh its known risks and determination of the vaccine's efficacy; whether the conditions set forth by particular regulatory authorities for conditional approvals could be satisfied on a timely basis; whether and when the production facility may be certified or verified by particular regulatory authorities; disruptions in the relationships between us and our collaboration partners or third-party suppliers; risks related to the availability of raw materials to manufacture a vaccine; whether BioNTech's manufacturing capacity is commensurate with the demand for our vaccine; disruptions in the manufacturing stability; challenges related to our vaccine's ultra-low temperature shipping and storage; whether and when additional supply agreements will be reached and other potential difficulties.
The information contained in this release is as of July 11, 2021. Fosun Pharma assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
A further description of risks and uncertainties can be found in Fosun Pharma's Annual Report for the fiscal year ended December 31, 2020, including in the section thereof captioned 'Potential Risks', all of which are filed with the Hong Kong Stock Exchange and the Shanghai Stock Exchange and available at www.hkexnews.hk, www.sse.com.cn and www.fosunpharma.com.
+49 (0)6131 9084 1513
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
Fosun Pharma Contacts:
Barney Liu, Deputy Director of Media and Public Relations
+86 21-3398 7123