HONG KONG – After being granted phase II trial approval in Sierra Leone last Saturday for its novel Ebola vaccine, Tianjin Cansino Biotechnology Inc. became the first Chinese vaccine company with a self-developed vaccine approved for clinical trials in a foreign country.

“The first foreign clinical trial approval of a China-developed novel vaccine is a meaningful event, I expect more invented-in-China biopharmaceutical products will go global in [the] near future,” Jeanne Wang, operation director of Cansino, told BioWorld Today. “Phase II and III of Ebola vaccine need to be done in the epidemic area; [the] phase II clinical trial for our vaccine is progressing smoothly in Sierra Leone.”

The phase I trial of Cansino’s recombinant Ebola vaccine was done at Taizhou China Medical City and Zhe Jiang University on both Asian and African ethnic groups. The vaccine proved to be highly targeted, stable and safe. It also can stay active for two weeks at a temperature of 37 degrees Celsius, which is suitable for the tropical environments in Africa where the Ebola epidemic burst last year and where there is a marked lack of a cold chain supply system. The first round of vaccination for the phase II trial has been finished.

Cansino is also investing a total of ¥2 billion (US$315 million) into a production facility in Tianjin, a port city near the Chinese capital of Beijing. Although the new facility is the first mass production site for an Ebola vaccine in Asia, it is much more than just that.

“We’re at a transitional stage from R&D to industrialization,” said Wang. “The facility is for all the vaccines in our pipeline.”

“We’re building the manufacturing facility for not only the Ebola vaccine, but also other vaccine products,” said Wang. “The ¥2 billion investment is the total investment for the entire project, not just for the Ebola vaccine line.”

Wang also said because there hasn’t been an Ebola outbreak in China or Asia, the company’s Ebola vaccine manufacturing capacity will be geared mainly at stockpiling and the product will be supplied based on demand.

Cansino co-developed its novel recombinant adenoviral Ebola vaccine with the Bioengineering Institute of the Chinese Academy of Military Medical Sciences. It is the third Ebola vaccine in the world to enter clinical trials. (See BioWorld Today, Dec. 22, 2014.)

Cansino has confirmed the investment project with the Tianjin government and the industrial land use has been approved. The company will release more details of the investment soon.