Established:Jan. 10, 2014
Chairman:Chan, Chi-Shean, MD
GeneralManager: Liu, Chung-Cheng, Ph.D.
ChiefFinancial Officer: Chang, Victor
EnimmuneCo., Ltd., is a joint venture vaccine development and marketing company of Adimmune together with venture capital investors, with Enterovirus 71 vaccine being its first product, as enterovirus is a subtropical epidemic disease with no approved vaccine in the domestic market yet. There are presently high demands for the vaccine, no approved supply to meet the demands. By using Adimmune’s serum-free cell culture technology and bioreactor production plat form for enterovirus 71 vaccine production, Enimmune is tasked for conducting clinical trials, obtaining marketing authorizations, and supply domestic and overseas markets for prevention of the epidemic and to reduce infection rates and severe illnesses among infants and young children.
Enterovirus 71 and Other PipelineProjects Milestones
Themilestones for the development of enterovirus 71 vaccine and other pipelineproducts are as follows:
(1)Completion of Phase II clinical trial of enterovirus 71 vaccine produced withroller bottle process in Taiwan;
(2)Completion of the comparison between the roller bottle process and thebioreactor process;
(3)Completion of the Phase II clinical trial of enterovirus 71 vaccine producedwith bioreactor processes in Taiwan, commence Phase III clinical trial usingbioreactor process in Taiwan, and prepare for Phase III clinical trials inChina and Southeast Asia;
(4)Planning for enterovirus 71 vaccine NDAsin Taiwan, China and Southeast Asia, and planning for future marketing andsales in Taiwan, China and Southeast Asia;
(5)Developments of cell culture Japanese encephalitis vaccine and other newvaccines using bioreactor process.
Vaccinemanufacturing processes are developed and practiced by Adimmune, while Enimmuneis tasked for products development and clinical trials. Enimmune will contract Adimmune forpre-clinical R&D developments and then in-license the results from Adimmuneor other bio technology research organizations or companies. Adimmune or other CMO companies will then beentrusted with the manufacture and supply the vaccines, and Enimmune will beresponsible for marketing and sales of the commercial products.
Thefirst product of Enimmune is enterovirus 71 vaccine. With the help fromAdimmune’s manufacturing expertiseand its experienced cell culture productionteam, combined with its manufacturing facility that meets international GMP standards, Adimmune will beable to produce for Enimmune high-quality vaccines for both domestic andoverseas markets.
Theparent company Adimmune is a reputable and highly-professional vaccine manufacturer whose GMP certifications are internationally recognized. A commercial scale bioreactor line andcorresponding processes have been established for superior vaccine. The initial research and development cost for Enimmune’s products are minimized due to thee arly-stage R&D undertaken by Adimmune. During the early stage of Enimmune, most of the functions were supported by Adimmune in order to reduce Enimmune’s overhead costs. The hand-foot-and-mouth disease caused by the enterovirus 71 virus is a subtropical epidemic disease, which frequently causes severe diseases. At present, there is no vaccine available in Taiwan and Southeast Asia while the demands are high.