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Sinovac COVID-19 Vaccine Collaboration with Butantan Receives Approval from Brazilian Regulator for Phase III Trial

 

  • Date: 2020-07-06
     
http://www.sinovac.com/?optionid=754&auto_id=907

  • Pageview: 20017

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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PostSubject
#375  Sticky Note $SVA [PHASE-3 Sinovac COVID-19 Vaccine Collaboration with Butantan mick 07/19/20 10:53:17 PM
#392   Sinovac Biotech Ltd (SVA) mick 09/25/20 08:47:20 PM
#390   Sinovac Biotech Ltd (SVA) mick 09/05/20 02:42:27 PM
#389   Sinovac Biotech Ltd (SVA) mick 08/16/20 01:10:49 PM
#388   $SVA YES mick 08/12/20 10:57:05 PM
#387   So $SVA after 1 year suspension they continued StockRoomBully 08/11/20 07:43:31 AM
#386   $SVA i think so mick 08/10/20 11:45:54 PM
#385   Mick whats the deal man. When this gonna StockRoomBully 08/10/20 10:07:23 PM
#384   Indeed. Could this start trading again? StockRoomBully 08/10/20 10:00:33 PM
#383   $SVA 10yr, Chart NASDAQ mick 08/10/20 05:00:53 PM
#382   $SVA 10yr, Chart NASDAQ mick 08/10/20 05:00:53 PM
#381   charting.nasdaq.com/ext/charts.dll?2-1-14-0-0-524-03NA000000SVA-&SF:6/8/2 mick 08/10/20 04:58:33 PM
#380   $SVA MAYBE $100 PLUS IF TRADING , UNBELIEVABLE mick 08/10/20 04:56:09 PM
#379   Unbelievable phase human trials StockRoomBully 08/10/20 04:22:12 PM
#378   $SVA they did some off da cuff trading [violations] mick 08/10/20 04:20:40 PM
#377   Why this not trading? Anyone knows StockRoomBully 08/10/20 04:12:04 PM
#376   $SVA Sinovac Biotech Ltd (SVA) mick 07/25/20 03:32:57 PM
#375   $SVA [PHASE-3 Sinovac COVID-19 Vaccine Collaboration with Butantan mick 07/19/20 10:53:17 PM
#374   $SVA 10yr, Chart NASDAQ mick 07/19/20 10:47:04 PM
#373   $SVA TWO YEAR CHART: NASDAQ mick 07/19/20 10:46:39 PM
#372   $SVA STUDIED SOME READS PHASE 3 mick 07/19/20 10:44:41 PM
#371   $SVA , I WONDER IF $SVA WILL EVER mick 07/19/20 10:29:09 PM
#370   SVA China may beat the USA with TREND1 07/19/20 10:21:43 PM
#369   Studied the details using the internet . TREND1 07/19/20 08:27:58 PM
#368   $SVA WHAT HAPPENED ????? mick 07/19/20 08:20:02 PM
#367   $SVA https://www.cnbc.com/quotes/?symbol=SVA&qsearchterm=SVAlbard mick 07/19/20 08:18:57 PM
#366   $SVA IS TRADING HALTED ????? TREND1 07/19/20 07:12:06 PM
#365   $SVA IS TRADING HALTED ????? mick 07/19/20 06:43:31 PM
#364   $SVA Report of Foreign Issuer (6-k) Edgar mick 07/19/20 05:35:02 PM
#363   $SVA Sinovac COVID-19 Vaccine Collaboration with Butantan Receives mick 07/19/20 05:34:49 PM
#362   $SVA Report of Foreign Issuer (6-k) Edgar (US mick 07/19/20 05:34:13 PM
#361   $SVA Report of Foreign Issuer (6-k) Edgar (US mick 07/19/20 05:33:28 PM
#360   $SVA Report of Foreign Issuer (6-k) Edgar (US mick 07/19/20 05:32:54 PM
#359   $SVA Report of Foreign Issuer (6-k) Edgar (US mick 07/19/20 05:32:09 PM
#358   $SVA Sinovac Biotech Ltd (SVA) mick 07/19/20 05:30:38 PM
#357   Sinovac COVID-19 Vaccine Collaboration with Butantan Receives Approval TREND1 07/19/20 11:48:00 AM
#356   ONLY 3RD IN PHASE 3 TRIAL OF COVID TREND1 07/19/20 11:40:29 AM
#355   PE Ratio = 20.20 TREND1 07/19/20 11:39:34 AM
#354   Revenue=$ 246.05M TREND1 07/19/20 11:38:34 AM
#353   Market Cap = .639 B TREND1 07/19/20 11:37:21 AM
#352   What a piece of shit company...No trades today...Lmfao starkd748 04/30/20 03:55:06 PM
#351   Chinese medicine at its finest it works so starkd748 04/30/20 06:11:43 AM
#348   Nobody wants poison injected in them not even starkd748 04/30/20 04:42:33 AM
#346   Is it, or does it just not trade much? Stock_Barber 04/16/20 11:14:05 AM
#345   $SVA: Just saw it .... but its halted ?????? makinezmoney 04/16/20 11:01:10 AM
#344   Sinovac being featured on CNBC right now! Stock_Barber 04/16/20 10:59:21 AM
#343   does anyone know when the buyout is supposed john12 09/25/17 11:21:14 AM
#342   Sinovac Biotech to Supply Flu Vaccine in Beijing Belugas 07/23/14 10:02:00 AM
#341   Sinovac Biotech Selected As Sole Provider Of Hepatitis Belugas 07/21/14 08:34:27 AM
#340   The Department of Disease Control (DDC) is using Belugas 07/02/14 12:39:08 AM
#339   By Jeff Pierce tradewithzen 07/01/14 10:04:48 AM
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