HONG KONG – China has approved a domestically developed vaccine for the deadly Ebola virus and is now the third country in the world, after the U.S. and Russia, with an approved vaccine. The CFDA-approved vaccine was co-developed by the military-backed Bioengineering Institute of the Chinese Academy of Military Medical Sciences and private drugmaker Cansino Biologics Inc., of Tianjin.
The World Health Organization (WHO) "approached us a couple times and we are well prepared for mass production if the virus made a comeback," Wang Jing, vice president of the Tianjin-based biopharma firm, told BioWorld Asia.
The vaccine, named recombinant Ebola virus disease vaccine (Adenovirus type 5 vector), is a recombinant replication defective human Ad5 vector-based vaccine expressing Ebola virus glycoprotein, which can stimulate immunity against the Ebola virus in both human cells and bodily fluids, according to the CFDA. The Chinese regulator highlighted in the announcement that the newly approved vaccine is superior to the currently available vaccines in terms of the stability.
"The final product is lyophilized white powder, and compared with the liquid vaccines, is more stable," said Wang. "Considering the weather conditions in Africa and relative lagged behind infrastructure, it is easier for the storage in those countries."
The vaccine is based on the 2014 mutant gene type and in the form of freeze-dried powder, which can remain stable for at least two weeks in temperatures of up to 37 degrees Celsius.
The vaccine was approved for clinical trials by the CFDA in February 2015 and has undergone trials in Sierra Leone, one of the countries worst hit by Ebola.
In 2014, Ebola ravaged West Africa and the death toll rose to more than 11,000 from 28,616 cases in Guinea, Liberia and Sierra Leone. During the outbreak, the virus also spread to Europe and the U.S., according to the WHO.
China established an Ebola special working committee in January 2015 and the CFDA approved the application for clinical tests of the drug in February 2015 and put the vaccine in an express approval system. Within two months, an application for registration of production was filed, the CFDA said.
"We were not particularly in that area until the Military Medical Sciences team came to us in 2014. The team had conducted research into the Ebola virus for years before the breakout, and it needed a platform that was capable of producing the research prototype into a final vaccine product that can be marketed," said Wang. "And within about two years – we benefitted from the favoring policies from the government – we made it. We believe that it demonstrates not only Cansino's, but also our Chinese biomedicine sector's ability in the technological innovation."
The CFDA noted in the approval announcement that the vaccine improves China's ability to prevent and control major public health threats and provides a new means for China to handle global disease epidemics effectively. It will promote research and development of vaccines for major infectious diseases in China.
The approval of the Ebola vaccine took place after Xi Jinping's remark about highlighting the government's focus on upgrading the country's health care industry when delivering a report to the 19th National Congress of the Communist Party of China on Oct. 18.
The president pledged that China will carry on the country's Healthy China initiative and will establish distinctively Chinese systems for providing quality and efficient health care services.
Becoming a biotech powerhouse
China became the world's second-largest pharmaceutical market after the U.S. in drug consumption in 2016. But the country's aim is not just further expanding its pharmaceutical sector; its ambition lies in biotechnology. The determination of becoming the world's powerhouse of biotech can be observed from the 13th Five-year Plan, 2016-2020 which includes a special report issued by China's Ministry of Science and Technology, stating that China's biotech sector will exceed 4 percent of GDP by 2020.
Zhang Zhaofeng, director of MOST's Science and Technology for Social Development, said last year that by 2020, China will build 10 to 20 science parks for biomedicine with a total output value surpassing ¥10 billion (US$1.45 billion).
Currently there are two major state funding sources, the State High-Tech Development Program and the Basic Research Program, offering incentives for more than 500 biopharma local companies. Tianjin Cansino is one example among them.
"It is the best time for biotechnologies with encouraging policies and incentives," said Wang. "Cansino is currently looking at three areas: producing our own vaccines that can replace those currently dominated by imported products, upgrading current domestic vaccines and brand-new vaccines. For example, currently, 4-valent meningitis conjugate vaccine is still absent in Chinese market and we hope to bring that to China as soon as possible. "
The company has been working on vaccines for more common diseases, including tuberculosis and meningitis, with a couple new vaccines now in the final stages of clinical trials.
In April, it received $65 million in a financing round led by Future Industry Investment Fund and since its founding in 2009, the company has announced three rounds of funding, including $10 million in early stage financing led by Lilly Asia Ventures and $30 million in a B round led by Qiming Ventures with Lilly Asia joining. On Oct. 20, the construction of the company's new vaccine production plant, covering 65,000 square meters, was completed.