Last week, a factory in China launched the world ’s first batch of hepatitis E virus vaccines, hopefully curbing this disease that infects about 20 million people each year and kills 70,000 people. This vaccine is hailed as an unusual example of successful public-private cooperation, setting a precedent for China's emerging biotechnology sector and helping to develop vaccines for other diseases that Western countries ignore.
Water-borne hepatitis E virus (hepatitis E virus) mainly occurs in developing countries with poor sanitary conditions, especially in Southeast Asia. Although the condition is mild in most cases, it can lead to acute liver failure-in some areas the mortality rate reaches 4%, and the mortality rate of women in late pregnancy rises to 20%. For example, between 1986 and 1988, a severe hepatitis E outbreak in northwestern Xinjiang Uygur Autonomous Region caused 120,000 infections and more than 700 deaths. At present, there is no effective treatment, so far, improving the health conditions is the most effective way to contain this disease.
This new vaccine, approved by China's State Food and Drug Administration (SFDA) in December 2011, may change this situation. More than a decade ago, researchers at Xiamen University in Fujian Province produced a protein by genetically modifying an E. coli strain. Injecting it into the human body can stimulate the body's immune system to fight against hepatitis E. However, it was not until 2000 that the preclinical and clinical development was officially carried out. At this time, Yangshengtang Group, which is interested in food and health care, invested 15 million yuan to establish a joint venture biotechnology laboratory with Xiamen University. The laboratory was accredited by the Ministry of Science and Technology of China in 2006 and restarted as the National Infectious Disease Diagnostic Reagent and Vaccine Engineering Research Center (NIDVD).
The institute aims to unite academia and industry to commercialize new vaccines, especially for emerging infectious diseases. Yangshengtang established a subsidiary called Xiamen Wantai Canghai Biotechnology Co., Ltd. (INNOVAX) to promote potential vaccines into clinical production through clinical trials. The hepatitis E vaccine Hecolin is the company's first product to enter the market. In addition, the company has an existing vaccine against human papillomavirus that has entered the preclinical research stage. In 2010, Hecolin was approved after a phase III clinical trial confirmed that it can effectively prevent infection in approximately 100,000 healthy participants.
The development cost of Hecolin is about 500 million yuan, most of which is funded by the Chinese government to Xiamen University. The vaccine will be sold to Chinese sellers at a price of RMB 110 per dose. The company expects sales in 2013 to reach RMB 62 million. This is not a big gain, but Professor Jun Zhang, deputy director of NIDVD, said that the public and private development models have helped ensure the development of this important vaccine, regardless of whether it will be profitable for manufacturers.
Zhang Jun hopes that the success of Hecolin will attract more investment in such a plan, and said that this is what the Chinese government has always encouraged. "Many people, including representatives of multinational pharmaceutical companies, venture capitalists and Chinese local government officials, as well as Chinese entrepreneurs, consider this an outstanding example of biotechnology investment," he said.
Zhang Jun pointed out that GlaxoSmithKline, a British pharmaceutical manufacturer, has collaborated with the US military to develop another hepatitis E vaccine, which has shown promise in a phase II clinical trial. However, hepatitis E mainly occurs in developing countries, and such vaccines have little commercial potential. "Not only hepatitis E, but also many other plagues around the world," Zhang Jun said.
Medical products that target major diseases in the developing world, such as Hepatitis E, “will not be viewed as opportunities to make a lot of money. New companies operating under different investment models provide a great opportunity that may have far-reaching effects, "Jeremy Farrar, director of the Oxford University Clinical Research Center in Ho Chi Minh City, Vietnam.
Hecolin may have come at the right time to address the rise in the number of hepatitis E in Africa. In Africa, the outbreak of hepatitis E in Uganda in 2007 infected more than 10,000 people, resulting in 160 deaths. By the end of September this year, since August, hepatitis E in Kenyan refugee camps was reported to have caused more than 200 cases of jaundice. Three refugee camps in the Republic of South Sudan have reported 16 deaths and 400 cases of hepatitis E infection since July. . "The number of cases is increasing, which puts tremendous pressure on available health services and resources. This is a major humanitarian issue," the Ministry of Health of the Republic of South Sudan said in a statement in September.
Xiamen University and Innovax are negotiating with the World Health Organization (WHO) to adopt WHO's Prequalification Programme to register Hecolin. "We must ensure that these vaccines can be used anywhere. If these products are not available outside of China, it will be a great regret," Farrar said.
He added: "We must accept the fact that companies like this will be extremely important in China in the future. The rest of us must catch up. We need to find a way through WHO to ensure that their vaccines are absolutely transparent, safe and effective . "
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