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Pipeline
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Current
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Milestone
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Market Potential |
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Human Vaccines
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EV71 (hand, foot, and mouth disease) Vaccine |
NDA Process
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Human clinical trials application accepted by SFDA on 12/25/09
Phase I was initiated in December, 2010
Phase II was completed in November, 2011 Phase III premilinary results came out in March,2013 and is under the NDA process
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~80M children (children aged 5 and under in China)
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Pneumococcal Polysaccharides
Vaccine (PPV)
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IND approved and obtained license to conduct clinical trials in May of 2014.
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obtained license to conduct clinical trials in May of 2014.
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Target Population:
Over 350 million people over age 50
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Chickenpox (Varicella)
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IND filed in January, 2013
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17.6 million doses supplied in China in 2013
Potentially being included in public market
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sIPV
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IND filed in October of 2014 |
IND filed in October of 2014 |
Target population of 16 million newborn schedule to 4 doses per child every year Commit to supply at least 20 million doses to other countries' public sector, if needed. |
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EV71 Vaccine |
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EV71 causes HFMD among children under ten years old. HFMD is a common and usually mild childhood disease; however, HFMD caused by EV71 has shown a higher incidence of neurologic involvement, and a higher acute fatal incidence. There have been a number of outbreaks of HFMD caused by EV71 in the Asia-Pacific region since 1997 including in China, Malaysia, Singapore, Australia, Vietnam and Taiwan. According to the China CDC in 2009, over 1.1 million cases were reported in China, with over 353 reported fatalities. In 2010, over 1.7 million cases were reported in China, with over 880 reported fatalities. In 2011, over 1.6 million cases were reported in China, with over 500 fatalities. And in 2012, over 2.16 million cases were reported in China, with over 560 fatalities. There is no identified treatment for enterovirus infections and no vaccine is currently available. We have started our research and development of the EV71 vaccine since 2007. In December 2009, the CFDA accepted our application to commence human clinical trials, which was the first clinical trial application for the EV71 vaccine in China. We obtained the approval from the CFDA to commence clinical trials on December 23, 2010 and initiated phase I clinical trial for EV71 vaccine on December 30, 2010. We completed phase I and II clinical trials in 2011. And the phase III clinical trial was conducted in 2012 and the preliminary top-line result was announced in March 2013. The preliminary top-line result has shown good safety and immunogenicity. We have four pending PRC patent applications relating to the EV71 vaccine in China. Our EV71 vaccine will target children five years old or under, who number approximately 80 million in China.
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Varicella Vaccine |
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Varicella is a highly contagious infectious disease caused by the varicella-zoster virus (Herpesvirus 3, Human). It usually affects children, is spread by direct contact or respiratory route via droplet nuclei and is characterized by the appearance on the skin and mucous membranes of successive crops of lesions that are easily broken and become scabbed. Varicella is relatively benign in children, but may be complicated by pneumonia and encephalitis in adults. According to the NIFDC lot release records, 14.87 million doses of varicella vaccines were approved and released in China in 2012, compared to 14.2 million doses in 2011. We had completed the pre-clinical studies of a human vaccine against varicella. The clinical trial application was filed with CFDA in January 2013.
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