FDA feedback validates HUYA’s Integrated Co-Development Model for China-sourced Drug Candidates
San Diego, CA, USA – April 14, 2008 — HUYA Bioscience International (HUYA), the leader in U.S./China pharmaceutical co-development, today announced the outcome of the first pre-IND (Investigational New Drug) consultation with the U.S. FDA for a development-stage compound sourced from China. The new compound, HBI-8000 (CS055 / Chidamide), licensed from Chipscreen Biosciences, Ltd. of Shenzhen, China, shows promise for the treatment of a broad range of cancers and is nearing completion of a Phase I trial in China. HUYA holds exclusive development and commercialization rights to the compound worldwide outside of China, while Chipscreen maintains rights in China. Continue reading