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Sinovac Biotech Ltd (SVA)
6.47 ? 0.0 (0.00%)
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6.93 5.9 - - -
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SINOVAC Reports Unaudited Second Half of 2021 Financial Results and Files 2021 Annual Report on Form 20-F • Business Wire • 04/29/2022 10:30:00 PM
Annual and Transition Report (foreign Private Issuer) (20-f) • Edgar (US Regulatory) • 04/29/2022 10:06:41 PM
Sinovac Biotech Ltd (SVA)
6.47 ? 0.0 (0.00%)
Volume: 0 @-
Bid Ask Day's Range
6.93 5.9 - - -
SVA Detailed Quote
Sinovac Biotech Ltd (SVA)
6.47 ? 0.0 (0.00%)
Volume: 0 @-
Bid Ask Day's Range
6.93 5.9 - - -
SVA Detailed Quote
$SVA News: NuScale Power and Spring Valley Acquisition Corp. Announce Satisfaction of Contingency for $30 Million of Samsung C&T Corporation’s PIPE Investment 02/02/2022 01:50:00 AM
SVA News: AstraZeneca, Pfizer/ BioNTech or J&J shots found to boost effect of Sinovac COVID-19 vaccine 01/24/2022 06:25:26 AM
$SVA News: NuScale Power Announces Filing of a Registration Statement on Form S-4 in Connection With Its Proposed Business Combination With Spring Valley Acquisition Corp. 01/10/2022 01:55:00 AM
SVA News: Sinovac Biotech reports 1H results 12/30/2021 08:26:48 PM
SVA News: Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k) 12/30/2021 11:16:42 AM
Sinovac Biotech Ltd (SVA)
6.47 ? 0.0 (0.00%)
Volume: 0 @-
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6.26 14.0 - - -
SVA Detailed Quote
Sinovac Biotech Ltd (SVA)
6.47 ? 0.0 (0.00%)
Volume: 0 @-
Bid Ask Day's Range
6.4 6.26 - - -
SVA Detailed Quote
Sinovac Biotech Ltd (SVA)
6.47 ? 0.0 (0.00%)
Volume: 0 @-
Bid Ask Day's Range
6.26 14.0 - - -
SVA Detailed Quote
Sinovac Biotech Ltd (SVA)
6.47 ? 0.0 (0.00%)
Volume: 0 @-
Bid Ask Day's Range
6.47 14.0 - - -
SVA Detailed Quote
Sinovac Biotech Ltd (SVA)
6.47 ? 0.0 (0.00%)
Volume: 0 @-
Bid Ask Day's Range
0.0001 14.0 - - -
SVA Detailed Quote
Some countries consider booster shots for those who received Sinovac COVID-19 shot Seeking Alpha - 7/8/2021 11:47:47 AM
AeroFarms Expands its Award-Winning Leafy Greens Product Assortment Business Wire - 7/8/2021 8:00:00 AM
Sinovac’s reports COVID-19 vaccine trial results in children and adolescents aged 3 to 17 Seeking Alpha - 6/30/2021 6:53:46 AM
The Lancet Infectious Diseases Published Data from Sinovac’s Phase I/II Study, World’s First Published Study on Clinical ... Business Wire - 6/30/2021 6:30:00 AM
Sinovac Biotech Ltd (SVA)
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9.1 6.26 - - -
SVA Detailed Quote
WHO seeks more data on Sinovac Biotech’s COVID-19 vaccine - WSJ
May 26 2021 - 06:37AM
Seeking Alpha
To read the full story on Seeking Alpha, click here.
SVA News: WHO seeks more data on Sinovac Biotech’s COVID-19 vaccine - WSJ 06:37 AM
SVA News: AeroFarms to Participate in BMO Capital Markets 16th Annual Farm to Market Conference and Host IPO Edge Fireside Chat 05/18/2021 08:00:00 AM
SVA News: AeroFarms Doubles Leafy Greens Offering at Whole Foods Northeast Stores 05/13/2021 07:00:00 AM
SVA News: AeroFarms Announces Filing of a Registration Statement on SEC Form S-4 in Connection with its Proposed Bus. Combination with ... 05/10/2021 05:48:00 PM
SVA News: AeroFarms Wins 2021 Controlled Environment Agriculture Brand Excellence Award 05/06/2021 07:00:00 AM
News News Alert: WHO seeks more data on Sinovac Biotech’s COVID-19 vaccine - WSJ 05/26/2021 06:37:08 AM
Sinovac vaccine 67% effective against symptomatic infection in real-world study - Reuters Seeking Alpha - 4/16/2021 11:14:19 AM
AeroFarms Appoints Gary M. Cohen as Chief Revenue Officer to Drive Continued Global Growth and Category Expansion Business Wire - 4/6/2021 7:00:00 AM
Sinovac Announced Buildup of Two Billion Annual Capacity of Its COVID-19 Vaccine Business Wire - 4/1/2021 11:30:00 PM
AeroFarms & Hortifrut Announce R&D Partnership to Advance the Next Generation of Blueberry & Caneberry Production in Vertical... Business Wire - 3/30/2021 7:00:00 AM
Sinovac Biotech Ltd (SVA)
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SVA Detailed Quote
RELATED 'Sinovac Biotech Ltd (SVA)'
Vectoring Back In On Verrica Pharmaceuticals
Feb. 18, 2021 10:02 AM ETVerrica Pharmaceuticals Inc. (VRCA)4 Comments2 Likes
Summary
Today, we revisit a medical dermatology concern named Verrica Pharmaceuticals for the first time since late in 2019.
Yesterday, the company had its NDA resubmission accepted by the FDA, which should take action on the application by late June.
A full investment analysis follows in the paragraphs below.
I do much more than just articles at The Busted IPO Forum: Members get access to model portfolios, regular updates, a chat room, and more. Get started today »
Today, we revisit Verrica Pharmaceuticals (VRCA) for the first time since the close of 2019. It seems a good time to look back on this small-cap concern given it just had its key NDA resubmission accepted by the FDA around its main drug candidate. We take a gander at recent events and update our investment analysis around Verrica in the paragraphs below.
Sinovac’s COVID-19 vaccine is said to be effective against new variants
Feb. 18, 2021 11:57 AM ETSinovac Biotech Ltd. (SVA)By: Dulan Lokuwithana, SA News Editor4 Comments
CoronaVac,
the COVID-19 vaccine developed by Sinovac Biotech (NASDAQ:SVA) has shown efficacy against the variants first detected in the
U.K. and South Africa,
an official from Butantan biomedical center, the company’s Brazilian partner has said.
“We have tested this vaccine in China against the English and the South African variants,
with good results,” said Dimas Covas,
CEO of Butantan without offering further details.
The tests are also underway to evaluate its efficacy against the Brazilian variant, he has added.
Based on results from late-stage trials, the vaccine based on an inactivated virus has shown 100% and 83.7% efficacy against hospitalized/
severe/
fatal cases and
cases requiring medical treatment, respectively.
Now read: Vectoring Back In On Verrica Pharmaceuticals
https://seekingalpha.com/news/3663539-sinovacs-covid-19-vaccine-is-said-to-be-effective-against-new-variants?utm_source=advfn.com&utm_medium=referral
Sinovac’s COVID-19 vaccine is said to be effective against new variants
February 18 2021 - 11:57AM
Seeking Alpha
To read the full story on Seeking Alpha, click here.
RADAR COULD START TO TRADE 'Sinovac Biotech Ltd (SVA)'
Sinovac Biotech Ltd (SVA)
6.47 ? 0.0 (0.00%)
Volume: 0 @-
Bid Ask Day's Range
6.47 6.06 - - -
SVA Detailed Quote
TRADING STUFF $SVA
$SVA TO MY SURPRISE $125-K ASK
YOU SEE RECENT ASK /////\\\\\ $125-K ?????
Sinovac Biotech Ltd (SVA)
6.47 ? 0.0 (0.00%)
Volume: 0 @-
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7.03 6.4 - - -
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$Sbmff
Sino Biopharmaceutical: Investing In China's COVID-19 Vaccine While Sinovac Remains Halted
Dec. 12, 2020 10:28 AM
Sino Biopharmaceutical Limited ($SBMFF)AZN, AZNCF, CASBF
Summary
Sinovac Biotech has developed a successful COVID-19 vaccine, CoronaVac, directly competing with two Chinese rivals, Pfizer, AstraZeneca, Moderna and Russia's Sputnik V.
Nasdaq and Hong Kong-listed partner Sino Biopharm providing $515 million funding for 15.03% equity stake in Sinovac.
Sinovac's Nasdaq listing currently still halted after attack from activist shareholders.
Way forward unclear, but SEC seemingly supporting Sinovac's version of events. In the meantime, CoronaVac has been approved and currently in use in several countries.
Best opportunity to invest in CoronaVac's success is through Sino Biopharm.
One company that may have a promising lead on a COVID-19 vaccine, alongside international rivals such as Pfizer (PFE), AstraZeneca (AZN), Moderna (MRNA) and Camaleya's Sputnik V, is Sinovac Biotech (SVA), a Chinese biotechnology firm. Since mid-2020, the vaccine called 'CoronaVac' has been undergoing Phase III clinical research.
On October 19, preliminary results from the Phase III trial in Brazil showed CoronaVac appeared to be safe in providing protection against COVID-19.
By December 3, over a million doses of CoronaVac had arrived in Brazil.
https://seekingalpha.com/amp/article/4394397-sino-biopharmaceutical-investing-in-chinas-covidminus-19-vaccine-while-sinovac-remains-halted
12-23-2020 I LIKE to 'StockRoomBully' on 'Sinovac Biotech Ltd (SVA)'
1Globe Capital, the Largest Shareholder of Sinovac Biotech, Reached Agreement with SEC and Calls on All Stakeholders to Suppo...
December 23 2020 - 04:07AM
GlobeNewswire Inc.
Alert
Print
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1Globe Capital LLC (“1GlobeCap”), a principal and long-term shareholder of Sinovac Biotech (NASDAQ: SVA) (“Sinovac”),
has reached agreement with the Securities and Exchange Commission (“SEC”) to end investigation of its 13D form compliance.
During this critical phase of vaccine and therapeutics development for the ongoing pandemic,
1GlobeCap felt it was important to focus on its many projects,
which include the development of COVID-19 therapeutics and vaccines.
For this reason, 1GlobeCap decided to accept a SEC settlement offer, in which 1GlobeCap neither admitted nor denied SEC findings.
Following Sinovac’s annual general meeting (“AGM”) on February 6th in 2018,
the SEC investigated the reporting compliance of Sinovac shareholders. 1GlobeCap’s 13D/13G forms,
prepared by legal experts at top US law firms, disclosed that:
(1) 1GlobeCap held 22.4% of Sinovac shares; and
(2) 1GlobeCap intended to support the dissident shareholder of Sinovac Beijing which proposed a competing offer to the insider-led buyout.
1GlobeCap also communicated to Sinovac additional shares being held by its related parties.
The SEC investigation staff on 13D compliance concluded that:
(1) 1GlobeCap ’s ownership should also be inclusive of shares held by its related parties
(in aggregate ~32.3% of all Sinovac shares); and
(2) its 13D form should have been amended in a timely manner to
include its participation in voting for an alternative slate of directors organized and nominated by other shareholders to replace
the incumbent board.
Before and since the settlement,
SEC made no comments on the legitimacy of either the old or
new boards and has not been involved in Sinovac’s internal corporate conflicts.
1GlobeCap has unequivocally protected all shareholder interests
through its refusal to support any unfair buyout.
When an insider buyout group attempted to take over Sinovac at a
price below market value against the wishes of the majority of
shareholders and adopted a “poison pill” strategy to preclude competing offers,
1GlobeCap felt an obligation to adhere to its principles despite having been invited by the insider group to join them.
After over 90% of shareholders attending the AGM voted for a new board to prevent the takeover,
the insider buyout group induced the outgoing board to
"swallow" the poison pill to wrestle control at the expense of
the company.
This unprecedented move would have jeopardized years of progress
and caused significant turmoil at the company.
1GlobeCap’s success in obtaining injunctions in courts has prevented
the retaliatory and unlawful implementation of the “poison pill” targeted all shareholders who voted against the re-election of the
old board.
Moreover, the “Status Quo Order” issued by the Delaware Court of Chancery against the
“poison pill” effectively protected Sinovac’s normal operations regarding vaccine development.
In January 2020, 1GlobeCap’s Chairman had a productive meeting
with Sinovac’s CEO at the company’s headquarters concerning paths forward for the company,
importance of focusing on product development and offered its
support to develop a vaccine against the novel coronavirus. Subsequently,
there have been several follow up collaborative meetings between the two teams.
1GlobeCap, as the principal shareholder of Sinovac,
calls on all Sinovac stakeholders to put aside their differences
and work together to support Sinovac’s COVID-19 vaccine,
which is a front-runner among global COVID-19 vaccine programs.
Sinovac’s vaccine, if successful, could play a role in ending the pandemic,
which transcends all the issues previously preventing collaboration among Sinovac shareholders.
About 1Globe Capital and Its Investment in Sinovac Biotech (Nasdaq: SVA)
1Globe Capital LLC focuses on investment in private and public
companies in the healthcare and high-tech sectors.
1GlobeCap started to invest in Sinovac about 10 years ago.
Previously, 1GlobeCap always voted to support Sinovac management
and developed an amicable and collaborative relationship.
The saga began in 2016 when Sinovac finally achieved success in developing its first major revenue generating product after many
years of R&D financial loss.
Certain venture capital funds together
with certain Sinovac executives
(“Insider Buyer”) proposed to privatize Sinovac.
Another buyout group, led by PKV Sinobioway (“PKV”), offered a
higher bid. 1GlobeCap, invited to join by both buyout groups,
attempted to promote collaboration between the two buyout groups
and requested a transparent and fair sale process.
However, the board and management adopted a
“poison pill” strategy to prevent competing offers and accepted
a $7.0/share offer from the Insider
Buyers while rejecting a $8.0/share offer from PKV.
Frustrated investors, representing over 90% shareholders in attendance at the AGM,
voted for a new board organized by PKV and nominated by
OrbiMed Advisor LLC. Instead of a peaceful transition,
the management used company funds
(more than $20M according to company’s fillings)
to hire US lawyers and consultants to litigate and retaliate against
all shareholders voting against the re-election of the incumbent board.
Since the AGM in February 2018,
there has been no board elected by the majority of shareholders
to protect their interests and the trading of Sinovac has been kept suspended by Sinovac.
Boston Address: One International Place, 44th Floor, Boston, MA, 02110, USA
Beijing Address: Block B, Techart Plaza, No.30 Xueyuan Road, Haidian District, Beijing, 100083, P.R. China
Contact: Stella Wang
Email: Stellawang@1globe-china.com
Telephone: +86-10-62336199
12-23-2020 I LIKE to 'StockRoomBully' on 'Sinovac Biotech Ltd (SVA)'
Sinovac Biotech Ltd
http://www.sinovac.com/
1Globe Capital, the Largest Shareholder of Sinovac Biotech, Reached Agreement with SEC and Calls on All Stakeholders to Suppo...
December 23 2020 - 04:07AM
GlobeNewswire Inc.
Alert
Print
Share On Facebook
1Globe Capital LLC (“1GlobeCap”), a principal and long-term shareholder of Sinovac Biotech (NASDAQ: SVA) (“Sinovac”),
has reached agreement with the Securities and Exchange Commission (“SEC”) to end investigation of its 13D form compliance.
During this critical phase of vaccine and therapeutics development for the ongoing pandemic,
1GlobeCap felt it was important to focus on its many projects,
which include the development of COVID-19 therapeutics and vaccines.
For this reason, 1GlobeCap decided to accept a SEC settlement offer, in which 1GlobeCap neither admitted nor denied SEC findings.
Following Sinovac’s annual general meeting (“AGM”) on February 6th in 2018,
the SEC investigated the reporting compliance of Sinovac shareholders. 1GlobeCap’s 13D/13G forms,
prepared by legal experts at top US law firms, disclosed that:
(1) 1GlobeCap held 22.4% of Sinovac shares; and
(2) 1GlobeCap intended to support the dissident shareholder of Sinovac Beijing which proposed a competing offer to the insider-led buyout.
1GlobeCap also communicated to Sinovac additional shares being held by its related parties.
The SEC investigation staff on 13D compliance concluded that:
(1) 1GlobeCap ’s ownership should also be inclusive of shares held by its related parties
(in aggregate ~32.3% of all Sinovac shares); and
(2) its 13D form should have been amended in a timely manner to
include its participation in voting for an alternative slate of directors organized and nominated by other shareholders to replace
the incumbent board.
Before and since the settlement,
SEC made no comments on the legitimacy of either the old or
new boards and has not been involved in Sinovac’s internal corporate conflicts.
1GlobeCap has unequivocally protected all shareholder interests
through its refusal to support any unfair buyout.
When an insider buyout group attempted to take over Sinovac at a
price below market value against the wishes of the majority of
shareholders and adopted a “poison pill” strategy to preclude competing offers,
1GlobeCap felt an obligation to adhere to its principles despite having been invited by the insider group to join them.
After over 90% of shareholders attending the AGM voted for a new board to prevent the takeover,
the insider buyout group induced the outgoing board to
"swallow" the poison pill to wrestle control at the expense of
the company.
This unprecedented move would have jeopardized years of progress
and caused significant turmoil at the company.
1GlobeCap’s success in obtaining injunctions in courts has prevented
the retaliatory and unlawful implementation of the “poison pill” targeted all shareholders who voted against the re-election of the
old board.
Moreover, the “Status Quo Order” issued by the Delaware Court of Chancery against the
“poison pill” effectively protected Sinovac’s normal operations regarding vaccine development.
In January 2020, 1GlobeCap’s Chairman had a productive meeting
with Sinovac’s CEO at the company’s headquarters concerning paths forward for the company,
importance of focusing on product development and offered its
support to develop a vaccine against the novel coronavirus. Subsequently,
there have been several follow up collaborative meetings between the two teams.
1GlobeCap, as the principal shareholder of Sinovac,
calls on all Sinovac stakeholders to put aside their differences
and work together to support Sinovac’s COVID-19 vaccine,
which is a front-runner among global COVID-19 vaccine programs.
Sinovac’s vaccine, if successful, could play a role in ending the pandemic,
which transcends all the issues previously preventing collaboration among Sinovac shareholders.
About 1Globe Capital and Its Investment in Sinovac Biotech (Nasdaq: SVA)
1Globe Capital LLC focuses on investment in private and public
companies in the healthcare and high-tech sectors.
1GlobeCap started to invest in Sinovac about 10 years ago.
Previously, 1GlobeCap always voted to support Sinovac management
and developed an amicable and collaborative relationship.
The saga began in 2016 when Sinovac finally achieved success in developing its first major revenue generating product after many
years of R&D financial loss.
Certain venture capital funds together
with certain Sinovac executives
(“Insider Buyer”) proposed to privatize Sinovac.
Another buyout group, led by PKV Sinobioway (“PKV”), offered a
higher bid. 1GlobeCap, invited to join by both buyout groups,
attempted to promote collaboration between the two buyout groups
and requested a transparent and fair sale process.
However, the board and management adopted a
“poison pill” strategy to prevent competing offers and accepted
a $7.0/share offer from the Insider
Buyers while rejecting a $8.0/share offer from PKV.
Frustrated investors, representing over 90% shareholders in attendance at the AGM,
voted for a new board organized by PKV and nominated by
OrbiMed Advisor LLC. Instead of a peaceful transition,
the management used company funds
(more than $20M according to company’s fillings)
to hire US lawyers and consultants to litigate and retaliate against
all shareholders voting against the re-election of the incumbent board.
Since the AGM in February 2018,
there has been no board elected by the majority of shareholders
to protect their interests and the trading of Sinovac has been kept suspended by Sinovac.
Boston Address: One International Place, 44th Floor, Boston, MA, 02110, USA
Beijing Address: Block B, Techart Plaza, No.30 Xueyuan Road, Haidian District, Beijing, 100083, P.R. China
Contact: Stella Wang
Email: Stellawang@1globe-china.com
Telephone: +86-10-62336199
HELP US GET LISTED SEC Sinovac Biotech Ltd (SVA)
6.47 ? 0.0 (0.00%)
Volume: 0 @-
Bid Ask Day's Range
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SVA Detailed Quote
Excellent Mick... Hopefully this can trade again
Thanks for the update
i e-mailed da company today
i e-mailed da company today
$SVA news Years: http://www.sinovac.com/?optionid=772
--All--
2020-12-09Sinovac Announces Product License for 23-Valent Pneumoco...
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2020-11-10A Clarification of Interruption in Phase III trial On CO...
2020-09-28Beijing Fourth Intermediate People’s Court Issues Judge...
2020-09-23Sinovac’s Coronavac™, SARS-CoV-2 Vaccine (Vero Cell), ...
2020-09-22Sinovac Commences Phase III Clinical Trials for COVID-19...
2020-09-09Sinovac Reports Preliminary Phase I/II Results of COVID-...
2020-08-28Sinovac Reports Unaudited Second Quarter 2020 Financial ...
2020-08-25Sinovac Signs Agreement with Bio Farma Indonesia for COV...
2020-07-06Sinovac COVID-19 Vaccine Collaboration with Butantan Rec...
December 09, 2020 07:30 AM Eastern Standard Time
http://www.sinovac.com/?optionid=754&auto_id=918
BEIJING--Sinovac Biotech Ltd. (NASDAQ:SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that the China National Medical Products Administration (NMPA) has approved and issued a Product license for the Company’s 23-Valent Pneumococcal Polysaccharide (“PPV”) Vaccine to prevent the infection by streptococcus pneumonia in adults and children ages 2 years old and above.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “The approval of our pneumococcal vaccine allows us to provide another high-quality product to address unmet medical needs for the Chinese population. This is our first bacterial vaccine product approved so far, broadening the potential of the company’s product portfolio.”
Sinovac started research and development of the 23-valent pneumococcal polysaccharide vaccine in 2009, completed pre-clinical studies in 2011 and was approved to conduct human clinical trials in May 2014. A phase III non-inferiority study conducted in 2015 demonstrated a good safety and immunogenicity profile and non-inferiority of immunogenicity of all 23 serotypes were observed, which was published in the Human Vaccines and Immunotherapeutics medical journal.
About Streptococcus Pneumonia
Streptococcus Pneumonia, a highly bacterial pathogen, contains more than 90 serotypes. The pathogen is directly spread mainly through respiratory droplets and can cause many diseases including Pneumonia, meningitis, bacteremia, and otitis media, among others. Streptococcus Pneumonia usually affects children and elderly people and results in hundreds of thousands of deaths worldwide each year.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. Sinovac's product portfolio includes vaccines against enterovirus71 (EV71), hepatitis A and B, seasonal influenza, 23-Valent Pneumococcal Polysaccharide (“PPV”), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps. Healive, the hepatitis A vaccine manufactured by the Company, has passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. The Company is developing a number of new products including a Sabin-strain inactivated polio vaccine and combined vaccines. The COVID-19 vaccine, CoronaVac, developed by the Company is being tested in phase III trial in several countries outside of China. Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company is seeking market authorization of its products in over 30 countries outside of China. For more information please see the Company’s website at www.sinovac.com.
Safe Harbor Statement
This announcement may include certain statements that are not descriptions of historical facts, but are forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. In particular, the outcome of any litigation is uncertain, and the Company cannot predict the potential results of the litigation it filed or filed against it by others. Additionally, the triggering of a shareholder rights plan is nearly unprecedented, and the Company cannot predict the impact on the Company or its stock price as a result of the trigger of the rights plan.
This announcement contains forward-looking information about the Company’s efforts to develop a potential COVID-19 vaccine that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, 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 clinical data (including the Phase III trial data); the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase III trials or in larger, more diverse populations upon commercialization; the risk that clinical trial data are subject to differing interpretations and assessments, and by regulatory authorities; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels commensurate with global demand for any potential approved vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine candidate; uncertainties regarding the ability to obtain recommendations public health authorities; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.
Contacts
Sinovac Biotech Ltd.
Helen Yang
Tel: +86-10-8279-9871 or
+86-10-5693-1897
Fax: +86-10-6296-6910
Email: ir@sinovac.com
ICR Inc.
Bill Zima
U.S.: 1-646-308-1707
Email: william.zima@icrinc.com
$SVA [-chart]www.sinovac.com/file/upload/2010/10/21/1287886840.gif[/chart]
http://www.sinovac.com/
$SVA we need to dis reinstated Press Releases Company News
http://www.sinovac.com/
2017-10-17Partnership Opportunities
2014-12-01Sinovac Presents on “Vaccine World MENA...
2014-11-29Sinovac Attended The Third Open Innovati...
2014-07-28[Media Report] Congratulations! Inoculat...
2014-02-12[Media Report] H7N9 vaccine trials urged...
$SVA we need to dis reinstated Press Releases Company News
http://www.sinovac.com/
2017-10-17Partnership Opportunities
2014-12-01Sinovac Presents on “Vaccine World MENA...
2014-11-29Sinovac Attended The Third Open Innovati...
2014-07-28[Media Report] Congratulations! Inoculat...
2014-02-12[Media Report] H7N9 vaccine trials urged...
Sinovac Biotech Ltd (SVA)
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Turkey signed a deal with Sinovac for 50 million doses of the vaccine. The first three million doses are scheduled to arrive Monday in Turkey,
Mr. Koca said. Mr. Koca said Turkey would also get 4.5 million doses of the Pfizer-BioNTech vaccine by the end of March.
Around 1 million doses are expected to arrive at the end of January, he said.
CoronaVac, as Sinovac calls its vaccine, is made from killed coronaviruses.
The method is one of the oldest ones for making vaccines,
used by Jonas Salk in the 1950s
to make a vaccine against polio.
After viruses are inactivated with chemicals,
they cannot make people sick,
but they can provoke the immune system to make antibodies that can provide long-term protection against live viruses.
Turkish officials announced Thursday that a
vaccine from the Chinese company Sinovac has an efficacy rate of 91.25 percent,
but the finding was based on preliminary results from a small clinical trial and none of the data was published in a journal or posted online.
Sinovac’s mission is to Supply Vaccines to Eliminate Human Diseases.
To achieve these objectives, Sinovac focuses on research, development, manufacturing and marketing of human-use and animal-use vaccines. The Company also provides services for diseases control and prevention, collaborating with the Chinese governments at the national, state and local levels.
BEIJING--Sinovac Biotech Ltd. ( “Sinovac” or the “ Company”)(Nasdaq: SVA), a leading provider of biopharmaceutical products in China,
today announced an update to its previously announced partnership with Butantan, a leading Brazilian producer of immunobiologic products and vaccines.
On July 3, 2020, the Brazilian National Regulatory Agency,
Anvisa, granted approval to a
phase III clinical trial sponsored by Instituto Butantan to test efficacy and safety of the inactivated COVID-19 vaccine developed by
Sinovac Life Sciences Co., Ltd. ( or “Sinovac LS”, previously known as Sinovac Research and Development Co., Ltd. or
“Sinovac R&D”), a wholly owned subsidiary of the Company, in Brazil.
This trial aims to be a pivotal study to support the licensure of this product.
Anvisa’s process review included manufacturing and clinical information generated by Sinovac,
and a clinical development plan and trial protocol developed by Butantan.
The agency fast-tracked the application due to the public health emergency which took approximately two weeks to conclude.
The review was conducted at the highest standards as Anvisa is a full member of the International Council for Harmonization of
Technical Requirements for Pharmaceuticals for Human Use (“ICH”)
and qualified as a full functional regulatory agency for the World Health Organization (“WHO”) prequalification process.
This study will recruit nearly 9,000 healthcare professionals working in COVID-19 specialized facilities in twelve clinical sites located in several states in Brazil.
The inclusion of participants is scheduled to start this month after ethical approval is obtained from each clinical site.
"The phase III clinical trial approval is a demonstration that the Sinovac and Butantan partnership is an efficient collaboration to move forward offering hope to save lives worldwide,"
commented Dr. Dimas Covas, Director of Instituto Butantan.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “We are pleased to advance to Phase III trials with Butantan,
which will allow us one step further to our commitment to developing vaccines for global use and to our mission of supplying vaccines to eliminate human diseases.”
Sinovac LS initiated the development of an inactivated vaccine against COVID-19 (named CoronaVac) on January 28th, 2020.
Preclinical study results were published in the peer-reviewed academic journal Science.
On April 13th, 2020 the National Medical Products Administration (“NMPA”) granted approval to conduct phase I and II clinical trials in China.
The phase I and II trials commenced on April 16, 2020 in Jiangsu Province. China. A group of healthy adults aged 18-59 years old were vaccinated with a 0, 14 day schedule.
Preliminary phase I/II results were recently reported. There was no serious adverse event after vaccinating a total of 743 volunteers in the trials,
demonstrating a good safety profile for the vaccine candidate.
Over 90% seroconversion was observed in the phase II clinical trial 14 days after completion of a two-dose vaccination at day 0 and day 14.
A Phase II study on elderly adults is being conducted which will be followed by child and adolescent groups.
The phase II trial is expected to be completed at the end of 2020. The Company has partnered with several companies outside of China for phase III efficacy studies.
About Sinovac LS
Sinovac Life Sciences Co., Ltd., (or “Sinovac LS”), previously known as Sinovac Research & Development Co., td.,
is a research-based company incorporated in 2009 that conducts human vaccine research, development, manufacturing,
and sales. Sinovac LS is a wholly owned subsidiary of Sinovac Biotech (Hong Kong) Limited. It develops several human vaccines,
including vaccines against pneumonia, DTaP, Hib, hepatitis B vaccines and combo vaccines containing DTaP and Hib. Sinovac LS was granted 12 patents in vaccine technologies in China.
Sinovac Life Sciences is the developer of CoronaVac, an inactivated COVID-19 vaccine candidate,
and will be the marketing authorization holder of CoronaVac in China with a vaccine production license from China National Medical Products Administration (NMPA).
About Instituto Butantan
Instituto Butantan is the main producer of immunobiological products and vaccines in Brazil. Instituto Butantan carries out scientific missions
domestically and abroad through the Pan American Health Organization, the World Health Organization, UNICEF and the United Nations.
The Institute collaborates with other agencies of the São Paulo State Secretariat of Health and the Brazilian Ministry of Health for the
improvement of overall health in Brazil. It acts in partnership with various universities, research institutions, pharmaceutical companies,
and entities such as the Bill & Melinda Gates Foundation for the achievement of its institutional objectives.
For more information please visit the Institute website at http://www.butantan.gov.br or contact the press office at (+55 11) 2627-9606 / 9428 or email to imprensa@butantan.gov.br.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research,
development, manufacturing and commercialization of vaccines that protect against human infectious diseases.
Sinovac’s product portfolio includes vaccines against enterovirus71 (EV71), hepatitis A and B, seasonal influenza,
Quadrivalent Influenza vaccine (“QIV”), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps.
Healive, the hepatitis A vaccine manufactured by the Company, has passed the assessment under WHO prequalification procedures in 2017.
The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016.
In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine,
which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program.
The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program.
The Company is developing a number of new products including a Sabin-strain inactivated polio vaccine,
pneumococcal polysaccharides vaccine, and a SARS-CoV-2 (commonly referred to as COVID-19) vaccine.
Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets.
The Company is registering its products in over 30 countries outside of China. For more information please see the
Company’s website at http://www.sinovac.com.
Safe Harbor Statement
This announcement may include certain statements that are not descriptions of historical facts, but are forward-looking statements.
These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995.
These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements.
Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements.
In particular, the outcome of any litigation is uncertain, and the Company cannot predict the potential results of the litigation it filed or that could be filed against it by others.
Additionally, the triggering of a shareholder rights plan is nearly unprecedented, and the Company cannot predict the impact on the Company or its stock price should its rights plan have been triggered.
Contacts
Sinovac Biotech Ltd.
Helen Yang
Tel: +86-10-8279-9871
Fax: +86-10-6296-6910
ir@sinovac.com
Investors:
ICR Inc.
Bill Zima +1-646-308-1707
Email: william.zima@icrinc.com
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