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Sinovac Biotech's CEO Discusses Q2 2012 Results - Earnings Call Transcript

And now I would like to turn to our update on these programs. We actually have committed advancing the development of our EV71 vaccine. As all of you may know that it’s currently in the Phase III study. At the Phase III study, the endpoint is to evaluate efficacy of the vaccine and we discussed earlier we registered a trial early this year and we completed dosing and broad question and now it’s the center for disease control to work with the local laboratory on collecting the EV71 positive cases. These data that will be finally included in the statistical invoices for finally evaluating the efficacy profile of this vaccine.

And also in this quarter, we expect a visit and inspection by SFDA experts and the results are very positive and also grant us the opportunity to have a simultaneous communication between the healthcare workers related to the trial with the SFDA experts in order to allow the SFDA officials to have a interim review of the progress we made, in order to see that the process for regulatory approval of this vaccine.

And in general that this program is still being on schedule and everyone is working actively to be inline with our predicted target. And also in parallel, we are also very actively establishing the production plan for EV71. Currently in our Changping site, we have completed the installation of the equipment and right now we are in the validation process. And the GMP inspection for this site will be in line with our progress made with Phase III trial.

And our ultimate goals is to launch the vaccine, are to get a license of vaccine without any delay, meaning that we will have the facility prepared in parallel with the research. And also I would like to take a moment to provide you some detail about the current hand, foot and mouth disease epidemic in China. And there has been over 1.5 million hand, foot and mouth disease cases recorded in China, which is about 50% increase year-over-year growth. And this is very serious situation and that also gives a lot more pressure that we should move closely with the trial in order to provide the vaccine to help all the population as soon as we can. And also this citation from the government as well.

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