Pipeline
Current
Milestone

Market Potential

Human Vaccines

EV71 (hand, foot, and mouth disease) Vaccine

 
NDA Process
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
~80M children (children aged 5 and under in China)
Pneumococcal Polysaccharides
Vaccine (PPV)
 
 
IND approved and obtained license to conduct clinical trials in May of 2014.
 
obtained license to conduct clinical trials in May of 2014.
 
Target Population:
Over 350 million people over age 50
  
Chickenpox (Varicella)
IND filed in January, 2013
 
17.6 million doses supplied in China in 2013
Potentially being included in public market

 

sIPV 

 

 

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.

 

EV71 Vaccine

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.  

 Pneumococcal Polysaccharides Vaccine

 Pneumococcal polysaccharide vaccine, or PPV, is a vaccine used to prevent streptococcus pneumoniae (pneumococcus) infections, such as pneumonia and septicemia among adults aged 65 or older, adults with serious long-term health problems, smokers, and children older than two years with serious long-term health problems. We filed an application for clinical trials to the CFDA in February 2011 and obtained license to conduct clinical trials in May of 2014..

 

 

Varicella Vaccine

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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