Transcript Slide 1
Traditional Process U.S.A. Japan IND in the U.S. IND in Japan First in Human First in Human Single Ascending Dose Single Ascending Dose Multiple Ascending Dose Multiple Ascending Dose Phase II Phase II Phase III Phase III NDA in the U.S. NDA in Japan Japanese Bridging Strategy U.S.A. West Coast Clinical Trials (as a one stop shop for Phase I studies) IND in the U.S. Japan Skip Phase I Studies in Japan (1) Cost down (2) Shorten timeline to NDA First in Human First in Human Single Ascending Dose Single Ascending Dose Multiple Ascending Dose Multiple Ascending Dose Japanese Bridging Phase IIa Phase IIa Phase III Phase III NDA in the U.S. NDA in Japan Multi-Ethnic Bridging Strategy U.S.A. West Coast Clinical Trials IND in the U.S. FIH Japan / Korea / Taiwan Skip Phase I Studies in Japan, Korea, and Taiwan (1) Cost down (2) Shorten timeline to NDA in Japan, Korea and Taiwan SAD MAD China Include Chinese NDA in your global strategy without delay (After negotiation with SFDA, it is possible to concurrently conduct a required Chinese Phase I and Global Phase III study in China) Japanese PMDA accepts a NDA as long as approximately 15% of entire patient population in the global study is Asian (Chinese, Japanese, Korean, and Taiwanese). Chinese/Japanese/Korean Bridging Study IND in Japan, Korea, and Taiwan Phase II Phase II in Japan, Korea, and Taiwan Global Phase III (1) include Chinese, Japanese, Korean, and Taiwanese patients in the strategy NDA in the U.S. & Europe NDA in Japan NDA in Korea NDA in Taiwan Phase I in China NDA in China