Key Developments: Sinovac Biotech Ltd (SVA.O)
3.35USD
23 May 2013
$0.00 (+0.00%)
$3.35
$3.30
$3.38
$3.22
157,501
488,635
$5.09
$1.72
Latest Key Developments (Source: Significant Developments)
Sinovac Biotech Ltd Secures Contract To Supply Inactivated Hepatitis A Vaccine Healive Under Expanded Immunization Program
Sinovac Biotech Ltd announced that it has been selected by the Beijing Health Bureau and the Shanghai Centers for Disease Control and Prevention (Shanghai CDC) to supply the Company's inactivated hepatitis A vaccine, Healive, to the Expanded Program of Immunization (EPI) for each city. The tenders awarded to Sinovac in Beijing and Shanghai are valued at approximately RMB20 million and RMB13 million, respectively. The vaccine purchased by the Beijing Health Bureau will be administered over a two year period to the pediatric population across the city. The vaccine purchased by the Shanghai CDC is for the 2012 pediatric population inoculation program. Full Article
Sinovac Biotech Ltd Receives Beijing CDC Tender Award To Supply Seasonal Flu Vaccine Anflu To Beijing Citizens
Sinovac Biotech Ltd announced that it has been selected by the Beijing Centers for Disease Control and Prevention (Beijing CDC) to supply seasonal influenza vaccine to the citizens of Beijing. The Beijing CDC plans to order up to a total of 1.8 million doses of seasonal flu vaccine in 2012 for the vaccination campaign from four vaccine manufacturers. The total quantity of vaccine doses to be supplied will depend on the actual demand in Beijing. Delivery is expected to commence during the third quarter of 2012. Full Article
Sinovac Biotech Ltd Reports Progress In EV71 Vaccine Phase III Clinical Trial
Sinovac Biotech Ltd announced an update on Phase III clinical trial progress and commercialization preparation for inactivated Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD). The double-blinded, randomized, placebo controlled Phase III trial is being conducted at three sites across China's Jiangsu province. This study is designed to demonstrate the efficacy of the EV71 vaccine in the prevention of the diseases caused by EV71 in infants six to 35 months old. About 10,000 healthy infants completed the vaccination schedule in the first quarter of 2012, prior to the epidemic season for HFMD in China. The disease surveillance period began 28 days after completion of the two-dose regimen. A three arm active surveillance system, comprised of village health clinics, township hospitals, and local county Centers for Disease Control and Prevention (CDC), has been established at each clinical site and is in charge of epidemic surveillance, case diagnosis, epidemiological survey, and sample collection. Full Article
Sinovac Biotech Ltd Announces Progress in EV71 Vaccine Phase III Clinical Trial
Sinovac Biotech Ltd announced a positive SFDA inspection of the three clinical trial sites being used in the Company's Phase III study of its inactivated Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD). In May 2012, an expert from the Center for Drug Evaluation within the State Food and Drug Administration (SFDA) completed an inspection of the three Phase III study sites in Jiangsu Province, as well as the central laboratories set up by the Chinese Center for Disease Control and Prevention (CDC), according to the Good Clinical Practice (GCP) guidelines. As part of the inspection, study investigators from the three sites presented reports on the site's procedures of vaccination, safety monitoring and case surveillance, and the EV71 epidemic situation. The inspector also assessed the management systems at the three central laboratories, and their compliance with standard operating procedures. After the inspection, the SFDA expert positively acknowledged the comprehensive surveillance work performed by the clinical sites, and confirmed its importance to the clinical evaluation of the EV71 vaccine. Additionally, the SFDA expert indicated that the site inspection would facilitate further interaction between the SFDA and the investigators to solve any problems or issues that may arise during the study period, which will be beneficial as the Company advances through the regulatory process. Full Article
Sinovac Biotech Ltd. Names Danny Chung As Chief Financial Officer
Sinovac Biotech Ltd. announced that it has appointed Mr. Danny Chung as Chief Financial Officer, effective immediately. Ms. Nan Wang, who has served as interim Chief Financial Officer since August 2011, will continue as the Company's Vice President. Full Article
Sinovac Biotech Ltd. Issues FY 2011 Revenue Guidance Below Analysts' Estimates-Conference Call
Sinovac Biotech Ltd. announced that for fiscal 2011, it expects annual revenue to be in the range of $38-$40 million. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $64.90 million for fiscal 2011. Full Article
Sinovac Biotech Ltd. Reports Positive Preliminary Phase II Clinical Trial Results For EV71 Vaccine Against Hand, Foot And Mouth Disease
Sinovac Biotech Ltd. announced the positive results from its phase II clinical trial for its inactivated vaccine against human enterovirus 71 (EV71), which causes hand, foot and mouth disease (HFMD). The preliminary Phase II results for the EV71 vaccine showed a good immunogenicity and a favorable safety profile with no vaccine-related serious adverse event. The phase II trial was designed as a single center, randomization, double blinded, and placebo controlled study and enrolled 540 healthy volunteers, comprised of infants from six months to thirty-five months old. On November 8, 2011, the unblinding conference for the phase II clinical data was held under the supervision from the Data Safety and Monitoring Committee (DSMC), and was attended by experts from the China State Food and Drug Administration (SFDA) and the China CDC. The phase II clinical results have provided the reference data for phase III clinical trial, including the vaccination schedule and dosage selection, based on which the proper dosage can be selected to enter into the phase III clinical trial. The purpose for the phase III clinical trial is to evaluate the efficacy of protection against HFMD caused by EV71 and is designed as a multi-center, randomized, double-blinded and control study. Full Article
Sinovac Biotech Ltd. Secures Contract From Beijing CDC To Supply Seasonal Influenza Vaccine Anflu
Sinovac Biotech Ltd. announced that it has been selected by the Beijing Centers for Disease Control and Prevention (Beijing CDC) as one of the four manufacturers to supply seasonal influenza vaccine to the citizens of Beijing for the fourth time. Full Article
Sinovac Biotech Ltd. Receives GMP Certificate In Mexico For Seasonal Flu Vaccine And Hepatitis A Vaccine
Sinovac Biotech Ltd. announced that it has obtained the GMP certificate for its seasonal flu vaccine and hepatitis A vaccine from the Mexican regulatory authority, the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) of Mexico Ministry of Health. Sinovac is the Chinese vaccine manufacturer to be granted GMP certificate by COFEPRIS. The GMP certification follows the onsite inspection by COFEPRIS at Sinovac's Beijing headquarters in September 2010. The GMP certificate is effective for 30 months with an expiration date of January 12, 2014, at which time a new GMP inspection shall be applied for the renewal of GMP certificate. Laboratorios Imperiales S.A. de C.V., a biopharmaceutical company with operations in Mexico since 1935, is the exclusive distributor of Sinovac's vaccine products in the Mexican market, pursuant to a prior distribution agreement signed in 2005 with its affiliate. Full Article
Sinovac Biotech Ltd. Announces Resignation Of Chief Financial Officer
Sinovac Biotech Ltd. announced the resignation of Jacob Chik Keung Ho, Chief Financial Officer, for personal reasons. The Company has initiated an executive search for a new Chief Financial Officer to replace Mr. Ho, who has agreed to remain with the Company until August 16, 2011. Ms. Nan Wang, Vice President of Sinovac, has been appointed as the Interim Chief Financial Officer. Full Article
Sinovac vaccine meets study goal; shares jump 60 percent
- China-based Sinovac Biotech Ltd said a late-stage trial of its experimental vaccine for hand, foot and mouth disease (HFMD) met the main study goal of preventing the infection in infants between the ages of 6 months and 35 months.
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