Eisen's new generation of targeted drug avitinib maleate has been officially approved by the U.S. FDA for Phase I clinical trials

On September 24, 2014, Aisen officially received a confirmation letter from the U.S. FDA agreeing to conduct clinical research, marking that Aisen's preclinical research on targeted anti-tumor drugs was recognized by the U.S. FDA and that it can legally conduct relevant clinical research in the United States. Eisen positioned it as an international variety in the early stages of development, and conducted all preclinical pharmaceutical research, pharmacology and toxicology research in accordance with the technical requirements of the US FDA and China CFDA. After months of compilation of registration materials in English, and detailed evaluation by the U.S. FDA's professional technical and regulatory consultants, Aisen believes that all technical information fully meets the U.S. FDA IND requirements, and a registration application can be submitted without applying for a pre-IND meeting. This fully reflects the professional and international advantages of Aisen's innovative drug R&D team. It will not only develop ivitinib maleate internationally, but will also develop more innovative drugs for unmet need (unmet clinical needs).