Therapeutic focus – Sinovac leads China’s hand, foot and mouth disease race

At a time when the track record of Chinese pharma stocks listed in the US has been patchy, Sinovac Biotech has enjoyed a decent run, fortified by yesterday’s apparent success in a massive phase III programme assessing its hand, foot and mouth disease (HFMD) vaccine.

The data highlight a disease that, while being largely ignored in the West, is a major health concern in China. EvaluatePharma identifies a handful of other players targeting HFMD, all of which are focused on Asia, and while there is also non-industry involvement it is clear that Sinovac is streets ahead of its peer group (see table).

True, Sinovac’s stock is down 50% since the company entered the Nasdaq in 2009, but its gains since momentum started to build around the HFMD study are significant, amounting to 64% over the past six months and 18% yesterday. Interestingly, the company seems immune to the economic headwinds that have hit some of its peers (Private bid brings Simcere and Chinese speculation down a peg, March 12, 2013).

Unmet need... in Asia

This is surely credit for its focus on what can be considered to be real innovation. While in the West there is little incentive to develop a vaccine against HFMD because the disease normally passes without treatment within seven days, in Asia it is considered a major health problem.

HFMD is an illness of infants and children, characterised by fever, sores in the mouth, and a rash with blisters. There is no specific treatment, and UK guidelines simply suggest drinking fluids and taking general analgesics. But China’s ministry warns that HFMD can be fatal if complications occur.

Indeed, most of the major outbreaks over the past 10 years have taken place in the Far East, and China reported 115,000 cases between January and April 2009 alone, 773 of which were severe and 50 fatal.

Several different viruses are thought to be responsible, and the most common is coxsackievirus A16. But enterovirus 71 carries a higher risk of serious complications, which can include dehydration and brain infections, and it is on this virus that industry has focused.

EvaluatePharma identifies the following six companies with active development projects. All are Chinese except Adimmune and Medigen, which are based in Taiwan, and Inviragen – unusually a private US biotech player.

Enterovirus vaccines in industry development
Status Name Company Trial ID
Phase III EV71 Vaccine Sinovac Biotech NCT01507857
Phase II HFMD (EV71) vaccine SINOPHARM
Phase I Enterovirus 71 (EV71) Vaccine Inviragen NCT01376479
Preclinical Enterovirus 71 Vaccine Adimmune
Research project EV71 Enterovirus Vaccine Medigen Biotechnology – 
EV71-VLP Tianjin CanSino Biotechnology – 
All data sourced to EvaluatePharma

Inviragen might be US-based, but its HFMD vaccine is clearly focused squarely at Asia, and its phase I study, in which the project generated immune responses in all 36 participants, was carried out in Singapore.

Sinovac is far more advanced, having run two large phase III trials. A study in 10,000 healthy infants has just shown its vaccine to offer 95% efficacy against HFMD caused by enterovirus 71 within a year of being dosed twice in the run-up to the HFMD epidemic season.

Unfortunately, the company has not revealed the comparative efficacy result for the study’s placebo group, and without knowing this it is impossible to gauge how efficacious the vaccine might be in a real-world setting. Serious adverse event incidence was comparable between the two groups, Sinovac said, while a second trial, in 1,400 volunteers, showed consistency between three vaccine lots.

Whatever the placebo comparison might be, Sinovac maintains that the result is sufficient for it to file the vaccine – its most advanced R&D project – for local approval. Morgan Stanley analysts expect launch in 2014.

With the paucity of other options, and apparent local government keenness to tackle HFMD despite its “self-limiting” nature, Sinovac will thus have a strong advantage if it can convince the local regulator that its vaccine really can make a difference. No doubt industry competition is on its way, but for now Sinovac seems to have a good window of opportunity.

To contact the writer of this story email Jacob Plieth in London at or follow @JacobEPVantage on Twitter

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