- Approximately 11,500 of the companies’ mRNA-based COVID-19
vaccine doses arrived on the Chinese Mainland to enable vaccination
campaign for German expatriates
- Vaccines expected to be available in Beijing, Shanghai,
Guangzhou, Shenyang and Chengdu
MAINZ, GERMANY, and SHANGHAI, CHINA,
December 22, 2022 (GLOBE NEWSWIRE) — 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) announced that the companies
provided approximately 11,500 doses of mRNA-based COVID-19 vaccines
which arrived on the Chinese Mainland on December 21, 2022.
The delivery contains both the companies’ Omicron BA.4/BA.5-adapted
bivalent COVID-19 vaccine and the monovalent COVID-19 vaccine.
“We thank the Chinese and the German governments
for their joint efforts and continuous support in helping us supply
German expatriates living in China with our mono- and Omicron
BA.4/BA.5-adpated bivalent mRNA COVID-19 vaccines,” said
Sean Marett, Chief Business and Commercial Officer at
BioNTech. “The arrival of the vaccine doses on the Chinese
Mainland is a great milestone for us as joint partners with Fosun
Pharma and our efforts to address this pandemic.”
Li Shengli, Executive President and
Chief Growth Officer of Fosun Pharma said: “Since the
outbreak of the COVID-19 epidemic, we have been working closely
with BioNTech. With the guidance and support of the relevant
national authorities, the R&D and clinical trial of our
mRNA-based COVID-19 vaccine in China have been executed rapidly. We
are glad to be working with BioNTech to provide vaccination to
German expatriates living on the Chinese Mainland, which is another
milestone in our global collaboration in fighting the COVID
pandemic.”
The doses are expected to be available in
Beijing, Shanghai, Guangzhou, Shenyang and Chengdu.
On March 16, 2020, BioNTech and Fosun Pharma
announced a strategic collaboration to develop and commercialize
COVID-19 vaccines based on BioNTech’s mRNA technology platform for
Greater China Market including the Chinese Mainland, Hong Kong
Special Administrative Region (SAR), Macau SAR and Taiwan region.
Thus far, the mRNA COVID-19 vaccine has been granted full approval
in Hong Kong SAR (December 2022) following Emergency Use
Authorization in January 2021, and Special Import Authorizations in
Macau SAR (February 2021) and Taiwan region (July 2021).
About BioNTechBiopharmaceutical
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, bispecific
immune checkpoint 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, Genentech, a member of the Roche Group, Regeneron,
Genevant, Fosun Pharma, and Pfizer. For more information, please
visit www.BioNTech.com.
BioNTech Forward-looking
StatementsThis 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 Fosun Pharma to develop and
commercialize COVID-19 vaccines, including the companies’ Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine and the monovalent
COVID-19 vaccine (including the provision of mRNA-based COVID-19
vaccines to German expatriates living in China, planned
regulatory submissions, qualitative assessments of available data,
potential benefits, expectations for clinical trials, the
anticipated timing of regulatory submissions, regulatory approvals
or authorizations and anticipated manufacturing, distribution and
supply); our expectations regarding the potential characteristics
of BNT162b2, any monovalent or bivalent vaccine candidates or any
future vaccine, in our clinical trials and/or in commercial use
based on data observations to date; the ability of BNT162b2, any
monovalent or bivalent vaccine candidates or any future vaccine, to
prevent COVID-19 caused by emerging virus variants; the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for clinical trials, regulatory submission dates,
regulatory approval dates and/or launch dates, as well as risks
associated with preclinical and clinical data (including Phase
1/2/3 or Phase 4 data), including the data discussed in this
release for BNT162b2, any monovalent or bivalent vaccine candidates
or any other vaccine candidate in BNT162 program in any of our
studies in pediatrics, adolescents, or adults or real world
evidence, including the possibility of unfavorable new preclinical,
clinical or safety data and further analyses of existing
preclinical, clinical or safety data; the expected time point for
additional readouts on efficacy data of BNT162b2, or any monovalent
or bivalent vaccine candidates or any future vaccine, in our
clinical trials; 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; 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 ability of BioNTech
to supply the quantities of BNT162 (including to the Chinese
Mainland, Hong Kong SAR and Macau SAR), any monovalent or bivalent
vaccine candidates or any future vaccine, to support clinical
development and market demand, including our production estimates
for 2022; that demand for any products may be reduced or no longer
exist which may lead to reduced revenues or excess inventory; the
availability of raw materials to manufacture a vaccine; our
vaccine’s formulation, dosing schedule and attendant storage,
distribution and administration requirements, including risks
related to storage and handling after delivery by BioNTech and
Fosun Pharma; the ability to successfully develop other vaccine
formulations, booster doses or potential future annual boosters or
re-vaccinations or new variant-based vaccines; the ability to
maintain or scale up manufacturing capacity on a timely basis or
maintain access to logistics or supply channels commensurate with
global demand for our vaccine, which would negatively impact our
ability to supply the estimated numbers of doses of our vaccine
within the projected time periods as previously indicated; whether
and when additional supply agreements will be reached; the ability
to obtain recommendations from vaccine advisory or technical
committees and other public health authorities and uncertainties
regarding the commercial impact of any such recommendations;
challenges related to public vaccine confidence or awareness; and
uncertainties regarding the impact of COVID-19 on BioNTech’s
trials, business and general operations. Any forward-looking
statements in this press release are based on BioNTech 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
vaccines for COVID-19, including Omicron BA.4/BA.5 and other
variants; 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 quarterly report on Form 6-K for the
three and nine months ended September 30, 2022, filed with the SEC
on November 7, 2022, 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 by law.
About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical
(Group) Co., Ltd. ("Fosun Pharma"; stock code: 600196. SH, 02196.
HK) is a global innovation-driven pharmaceutical and healthcare
industry group deep-rooted in China. Fosun Pharma directly operates
businesses including pharmaceutical manufacturing, medical devices,
medical diagnosis, and healthcare services. As a shareholder of
Sinopharm Co., Ltd., Fosun Pharma expands its areas in the
pharmaceutical distribution and retail business.
Fosun Pharma is patient-centered and clinical
needs-oriented. The company enriches its innovative product
pipeline through diversified and multi-level cooperation models
such as independent research and development, cooperative
development, license-in, and in-depth incubation. Fosun Pharma has
formed technological platforms for innovative small molecule drugs,
antibody drugs, and cell therapy with a focus on key disease areas
including oncology and immunomodulation, metabolism and digestive
system, as well ascentral nervous system. Fosun Pharma also
vigorously explores cutting-edge technologies, such as RNA, gene
therapy, ADC and PROTAC, to enhance its innovation
capabilities.
Guided by the 4IN strategy (Innovation,
Internationalization, Intelligentization, and Integration), Fosun
Pharma will uphold the development model of “innovation
transformation, integrated operation, and steady growth", with the
mission of creating shareholder values through strengthening its
independent R&D and external cooperation and enriching its
product pipelines, as well as promoting the global networks and
enhancing operational efficiency. Fosun Pharma will actively
promote the digital and physical business layout in the
pharmaceutical and healthcare industry and is committed to becoming
a first-class enterprise in the global medical and health
market.
For more information, please visit our official
website: 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 2022. 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 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 December 22, 2022. 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, 2021, and Interim Report for the six months
ended June 30, 2022, including in the section thereof captioned
“Potential Risks”, all of which are filed with The Stock Exchange
of Hong Kong Limited and the Shanghai Stock Exchange and available
at www.hkexnews.hk, www.sse.com.cn
and www.fosunpharma.com.
CONTACTS
BioNTech Media Relations Jasmina Alatovic +49
(0)6131 9084 1513 Media@biontech.de
Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074
Investors@biontech.de
Fosun PharmaBarney LiuDirector of Media and
Public RelationsTel: +86 21-3398
7123E-mail: liumingyi@fosunpharma.com
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