Traditional Process First in Human Single Ascending Dose Multiple Ascending Dose U.S.A. Japan Phase II Phase III NDA in Japan Phase II Phase III NDA in the U.S. IND in the U.S. First in Human Single Ascending Dose Multiple Ascending Dose IND in Japan

Japanese Bridging Strategy First in Human Single Ascending Dose Multiple Ascending Dose Japanese Bridging U.S.A. Japan Phase IIa Phase III NDA in Japan Phase IIa Phase III NDA in the U.S. IND in the U.S. West Coast Clinical Trials (as a one stop shop for Phase I studies) First in Human Single Ascending Dose Multiple Ascending Dose Skip Phase I Studies in Japan (1)Cost down (2)Shorten timeline to NDA

FIH SAD MAD Chinese/Japanese/Korean Bridging Study U.S.A. Japan / Korea / Taiwan Phase II in Japan, Korea, and Taiwan Phase I in China NDA in Japan Phase II Global Phase III (1) include Chinese, Japanese, Korean, and Taiwanese patients in the strategy NDA in the U.S. & Europe IND in the U.S. West Coast Clinical Trials Skip Phase I Studies in Japan, Korea, and Taiwan (1)Cost down (2)Shorten timeline to NDA in Japan, Korea and Taiwan NDA in 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) China Multi-Ethnic Bridging Strategy NDA in KoreaNDA in Taiwan IND in Japan, Korea, and Taiwan 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).