China Sets Framework for Advanced Therapeutic Development, GEN
June 18, 2026GEN quoted partner Todd Liao in an article about China’s new Order 818 regulations and their implications for the development and commercialization of advanced therapeutics, including cell and gene therapies. The article examines how the new framework creates an alternative pathway for certain therapies while signaling China’s broader effort to strengthen its biotechnology ecosystem.
Todd highlighted practical considerations for multinational companies operating in China, particularly the need to revisit existing licensing and collaboration agreements in light of the new dual-pathway system.
“Legacy agreements were written for a single-pathway world that no longer fully describes the Chinese landscape. If milestones are defined solely by NMPA events, a licensee commercializing [a therapeutic] through hospitals may never trigger them,” Todd said.