Drug lag and associated factors of orphan drugs approved by the U.S. in China

Our findings suggest that orphan drug approval delays in China have improved significantly, but still face significant challenges. China's involvement in the global collaborative development of drugs not only helps shorten the relative lag time for drugs to obtain approval in China but also avoids repeated trials and significantly improves R&D efficiency. We recommend that pharmaceutical companies include Chinese patients in the drug development stage so that they can enjoy cutting-edge innovative therapies more quickly.