China’s Order 818—Regulations on the Administration of Clinical Research and Clinical Translation and Application of Biomedical New Technologies—establishes a new commercialization pathway for cell and gene therapeutics, gene editing, and other advanced therapeutics. More importantly, it signals China’s intent to accelerate local innovation and standardize the drug development environment, thereby becoming a more important player in advanced therapy development and manufacturing. Order 818 allows therapeutics whose mechanisms of action are at the cellular or molecular level to be clinically translated at 3A hospitals (tertiary care hospitals, of which there are approximately 1,700) without requiring National Medical Products Administration (NMPA) drug registration. Once translational approval is granted, hospitals may begin charging patients for these treatments. A good move While the move appears to be viewed positively by the biopharma industry, some details are still being ironed out. For example, boundary delineation guidelines still need to be issued to specify which technologies fall under Order 818 and which remain under the NMPA’s purview. Interpretations of the order generally suggest that therapies intended for mass manufacturing and wide distribution will be governed by the NMPA, while personalized therapeutics may use the Order 818 pathway. “We definitely see this as a positive signal,” Boyang Wang, founder of Singapore-based global longevity fund Immortal Dragons, tells GEN. Because advanced therapeutics are intricate and often personalized, it’s quite difficult for them to use the standard NMPA pathway. Before Order 818 was enacted on May 1, “biomedical companies in China would initiate investigator-initiated trials and partner with any…
