Sinovac Biotech (NASDAQ:SVA) reported positive results from a Phase I trial of its vaccine for human enterovirus 71 (EV71), the virus that causes Hand, Foot, and Mouth Disease (HFMD). Sinovac needs to expand its portfolio of vaccines to regain profitability.
The company prospered in 2009-10 on its H1N1 flu vaccine, but those revenues have disappeared as Chinese consumers became afraid of vaccine-borne illnesses. In Q1, Sinovac announced nearly flat revenues of $4.7 million, though its net loss totaled $3.4 million. In a way, those results were almost an achievement: with virtually no flu-related revenues, the company’s hepatitis vaccine portfolio had to increase its sales by 50% to prevent sales from dropping precipitously.
Sinovac also announced recently that regulators have conducted a final GMP inspection of its Tangshan Yian production site, where the company plans to produce an animal rabies vaccine. When Sinovac receives an OK from the inspection, it will file for the final certifications that will allow it to launch the rabies vaccine.
In the Phase I trial of the EV71 vaccine, Sinovac enrolled 168 volunteers, split between three cohorts: adult, child, infant. A variety of doses were administered. The vaccine was well-tolerated without creating any major safety problems in each of the three target groups, and preliminary data show an effective immune response.
A Phase II trial is scheduled to start within one or two months. The company will further evaluate safety and tolerance of the EV71 vaccine candidates and use immune response to determine the vaccination dosage.