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Sinovac Biotech (Amex:SVA)

1. eastwing 29 juli 2005 09:29

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   Market Pulse: Sinovac Biotech gets China OK for vaccine production
   Wednesday July 27, 6:47 am ET
   By Sarah Turner
   
   LONDON (MarketWatch) -- Sinovac Biotech Ltd said that the Chinese State Food and Drug Administration has a issued a production license for its proprietary influenza flu vaccine, Anflu. The production license authorizes Sinovac to begin vaccine production and the company said it was now ready to complete the final step in the application process for Good Manufacturing Practises certification.
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   Sinovac Biotech, Ltd. specializes in the research, development, commercialization, and sale of human vaccines for infectious illnesses, such as Hepatitis A and Hepatitis B, influenza, and SARS in China and internationally. The company has three vaccines that have completed three phases of clinical trials: Hepatitis A, Hepatitis A&B combined, and influenza (flu). Its Hepatitis A vaccine, Healive, is an inactivated vaccine without any preservative. The company’s Hepatitis A&B combined vaccine, Bilive, which is awaiting approval to commence sales in China, induces the body’s immune system to generate antibodies as a reaction against Hepatitis A virus and Hepatitis B viruses. Its split flu vaccine completed clinical trials in April 2004. The company is based in Beijing, China.
2. [verwijderd] 6 maart 2006 17:10

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   volgt iemand die fonds nog??
3. [verwijderd] 6 maart 2006 19:31

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   Prview:
   
   De beste expert in Sinovac is in mijn optiek Randstory.
   Je kunt zijn kommentaar volgen op het Kyocera forum van Yahoo:
   finance.messages.yahoo.com/bbs?.mm=FN...
   
   Sowieso is dit een van de beste forums op Yahoo omdat er over van alles behalve Kyocera wordt gediscusieerd. Lees Randstory, Dr Stocks en Ron postings.
   
   Volgens Rand is SVA een goede speculative koop onder de $4.-
   
   Giraf
4. [verwijderd] 10 april 2006 14:38

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   SVA komt met PB. Voorbeurs handel + 4,3 %
   
   www.marketwatch.com/News/Story/Story....
5. [verwijderd] 19 juni 2006 16:47

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   Sinovac Announces Pandemic Influenza Vaccine Phase I Clinical Trial Preliminary Results
   Monday June 19, 9:44 am ET
   
   BEIJING, June 19 /Xinhua-PRNewswire/ -- Sinovac Biotech Ltd. (Amex: SVA - News) announced today the preliminary results of its proprietary Inactivated Pandemic Influenza Vaccine (Human-used Avian Flu Vaccine) (Panflu(TM)) in Phase I Clinical trials. The project of R&D on Avian Flu Vaccine for human is sponsored and supported by Ministry of Science and Technology, and is co- developed by the Chinese Centers for Disease Control and Prevention (CDC) and Sinovac.
   The preliminary results showed good immunogenicity, with a sero-positive rate of 78.3%, which exceeds the criteria for assessment of vaccines established by Committee for Proprietary Medicinal Products of the European Union.
   
   Sinovac CEO and Chairman of the BOD, Mr. Yin Weidong commented, "This is another success for China's biotechnology industry and an encouraging event for us at Sinovac. Our R&D programs have many proven successes and are the core of our business plan. It builds our organic product pipeline, enhances our marketing and sales programs, and creates synergy with our strategic partners."
   
   Conduct of Phase I Clinical Trials
   
   The purpose of Phase I was to provide an evaluation of vaccine's safety and immunogenicity and a reference for determining the vaccine dosage for Phase II Clinical Trial. The Trial was conducted at the Beijing Sino-Japan Friendship Hospital in Beijing China, using a double-blind, randomized method of testing. Double-blind studies are designed to eliminate subjective bias on the part of both the experimental subjects and researchers. In a double-blind experiment, neither the subjects nor the researchers know who belongs to the control group or the experimental group.
   
   For this clinical trial, 120 volunteers were divided into 4 groups of 30 persons each, of which 24 of were inoculated with the pandemic influenza vaccine and the other 6 with a placebo. Vaccine safety was documented through Blood Routing Tests, Blood Biochemistry Tests, Urine Routing Tests, and systemic observation of localized events. The preliminary result shows that Sinovac's vaccine is safe for humans; no serious adverse events occurred to any volunteers.
   
   Next Step
   
   Once the Phase I clinical trial is officially completed, Sinovac will start the application process with SFDA to approve commencement for the Phase II clinical trial. The Company will submit its summary report of Phase I Clinical trial, plan and protocol for Phase II Clinical trial and other relevant documents.
   
   About Panflu(TM)
   
   Sinovac's Panflu(TM) is a, inactivated whole virus vaccine with adjuvant. Four antigen dosages levels were tested in the Phase I clinical trial and all of them induced an immune response in the volunteers. The vaccine with 10ug antigen content demonstrated the best immunogenicity, with a sero-positive rate of 78.3%, which exceeds the criteria for assessment of vaccines established by Committee for Proprietary Medicinal Products of the European Union.
   
   International Cooperation
   
   The National Institute for Biological Standards and Control (NIBSC) provided Sinovac with a reassortant H5N1 virus strain to be used in the vaccine R&D process.
   
   About Pandemic Flu
   
   Signs of a possible pandemic flu have emerged in Southeast Asia, as lethal infections in poultry and humans, and infections of the H5N1 influenza virus strain continue to be reported. While there is no confirmed evidence of human-to-human transmission, there have been suspected cases identified in Indonesia in May 2005. It is feared that if the H5N1 influenza virus undergoes either a genetic alteration or recombination with a human influenza virus, a new subtype could emerge which could be both highly contagious and highly lethal in humans. Such a subtype could potentially cause a global influenza pandemic.
   
   Most health officials estimate a flu pandemic could last a year or more, and millions of lives could be at risk. It is believed that one of the most effective countermeasures against pandemic flu is to manufacture mass quantities of vaccines as quickly as possible.
   
   About Sinovac
   
   Sinovac Biotech Ltd. is a Chinese biopharmaceutical company, focused on research, development and commercialization of vaccines designed to combat human infectious diseases. Sinovac's vaccines include Healive(TM) (hepatitis A), Bilive(TM) (hepatitis B) and Anflu(TM) (influenza). Sinovac has vaccines in clinical trials to combat avian influenza (bird flu) and SARS.
   
   Additional information about Sinovac is available on the Company website, www.sinovac.com and the Sinovac Investor Relations website, finance.groups.yahoo.com/group/Sinova...
   
   To be added to our distribution list, please email: info@sinovac.com
   
   Safe Harbor Statement
   
   This announcement contains 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 words or phrases such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Among other things, the business outlook and quotations from management in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward- looking statement. Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.
   
   biz.yahoo.com/prnews/060619/lnm008.ht...