HONG KONG – Vaccine developers in China are stepping up their game to close China's gap with other countries in the novel vaccine development space.
"The industry is putting an emphasis on innovation. Many domestic players are making efforts to develop novel products, including us," Yi Zhang, chairman of China's Yisheng Biopharma Co. Ltd., told BioWorld Today. "Innovative vaccine development is still relatively lagging in China."
Yisheng said this week its U.S. research subsidiary, Yisheng US Biopharma Inc., entered a collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to develop a new vaccine against the Ebola virus using the double-stranded RNA-based Toll-like receptor 3 (TLR-3) agonist adjuvant technology (PIKA). The research partnership is based on Yisheng's patented PIKA adjuvant that will allow the two parties to work on more vaccine products against other viruses in the future.
"Our product against Ebola does not only enhance the efficacy of the vaccine by reducing the number of vaccinations; more importantly, it's a prevention-treatment double-effect vaccine," said Zhang. "It stimulates the immune system and raises the number of antibodies in cells.
"There isn't an Ebola vaccine that also helps treat the disease yet."
Zhang said the clinical trials of the Ebola vaccine would mostly likely to be conducted in Africa where the disease is originated and is most prevalent.
The PIKA adjuvant was developed by Yisheng and was selected as one of the "National Key Medicine Innovations" of China in 2013 by the National Ministry of Science and Technology.
Under the terms of the agreement, the scientists at USAMRIID will evaluate the potential of PIKA adjuvant for Ebola vaccine and possibly for other vaccine candidates.
Yisheng's other PIKA product, a vaccine against rabies virus, is about to enter phase II testing in Singapore. Phase I trials started in March. (See BioWorld Today, March 18, 2015.)
"USAMRIID has gained a great deal of experience with using vaccine adjuvants," said Sina Bavari, science director at USAMRIID. "TLR-3 agonists such as PIKA adjuvant are known to enhance immune responses. Adjuvants, such as PIKA, activate innate immune signaling and may be used to elicit a more robust immune response to the vaccine."
Changing the paradigm
According to Yisheng's Zhang, a "series of novel vaccines based on this technology are under preclinical and clinical investigations against rabies, HIV, hepatitis B, influenza, tuberculosis and other viruses, which could significantly change the clinical practice paradigms against many human and animal virus infections."
Yisheng's focus on developing novel vaccine products is in line with China's innovation push of the life sciences sector.
At the beginning of this month, the CFDA granted marketing approval for the world's first EV71 vaccine against the hand, foot and mouth disease, developed by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (IMBCAMS).
The enterovirus E71 inactivated vaccine (human diploid cell) is expected to significantly reduce the morbidity of hand, foot and mouth disease in China, and also control the number of severe cases and mortality.
IMBCAMS started the R&D of that vaccine in 2008 and was also backed by the government's key innovative program scheme. The protection ratio of the vaccine could reach 97.3 percent and it is ready for mass production and market launch.
Under the CFDA's overall environment of accelerating the approval process for innovative life science products, the regulators prioritized the reviewing of the vaccine. Because there is very little basic research done for EV71 virus globally, the CFDA had faced challenges during the reviewing process. But by engaging in early stages, collaborating with other domestic and foreign medical institutes and organizations, the CFDA finally gave the vaccine the nod of approval.
However, IMBCAMS is not the only entity developing an EV71 virus vaccine. One of China's biggest vaccine makers, Sinovac Biotech Ltd. (NASDAQ:SVA), is also getting close to getting a hand, foot and mouth disease vaccine, among other innovative projects that have made huge progress recently, on the market.
"Like several other Chinese vaccine makers, Sinovac is also developing our own EV71 vaccine and is very close to the market launch," said Helen Yang, investor relations director at Sinovac.
Sinovac obtained clinical trial approval for its Sabin Inactivated Polio Vaccine (sIPV) candidate earlier this month. The company is planning to build an additional manufacturing facility with annual capacity of 10 million doses to its existing Changping site.
"The new addition to Changping's manufacturing site will be used for the production of the newly approved polio vaccine upon approval as well as other Sinovac products," said Yang.
"Sinovac is the first developer of [a hepatitis A] vaccine in China and has been putting a lot of efforts into innovation over the years," Yang added. "The most advanced products in our R&D pipeline include the EV71 vaccine, the polio vaccine and a varicella vaccine that just got approved for human clinical trials."
Sinovac's R&D expenses were $2.2 million in the third quarter of 2015, compared with $2.5 million in the same period of 2014. The R&D expenses in 2014, 2013 and 2012 were $11 million, $8.4 million and $17 million respectively.