Biotech Values

[jq1234]

There are two routes for approval in China. One is via import drug route, the other is regular route. For import route, the drug has to be approved in host country first before can apply for registration trial in China. Mitsubishi Tanabe holds telaprevir rights in Japan, China, South Korea, and Taiwan via ammendment with VRTX in July 2009, thus the drug needs to be approved in Japan first before applying for import route to China - MT didn't have development plan outside of Japan up to July 2009. Sebivo case was different via regular route. Notice Sebivo pivotal trial not only included patients from China, but also conducted separate registration trial exclusively in China - either NVS on their own or via partner in China - to form the basis as new drug application in China, thus got earlier approval than via import route.