China Approves Record Number of Innovative Drugs, Prioritizing Patients and Rare Diseases

China Approves Record Number of Innovative Drugs in 2023

China's National Medical Products Administration (NMPA) has reported a significant increase in the approval of innovative drugs in 2023, with a total of 48 first-in-class medications receiving the green light. This represents the highest number of approvals in the past five years, surpassing the 40 drugs approved in 2023 and 21 in 2022.

The approved drugs cover a wide range of therapeutic areas, including oncology, neurological disorders, and anti-infective medicines. Notably, 17 of these drugs received approval through a priority review pathway, while 11 gained conditional market approval and 13 were included in breakthrough therapy programs during clinical trials.

The NMPA has implemented various measures to enhance review efficiency and expedite the approval of new and effective drugs, providing patients with a broader range of medication options. Additionally, the agency has approved 106 pediatric medicines and 35 medications with expanded pediatric indications, addressing the shortage of pediatric medication options.

To further accelerate drug approvals, the NMPA has established four accelerated pathways, including the priority review program for urgently needed medicines, those treating major infectious diseases and rare diseases, as well as upgraded new drugs, pediatric medications, and innovative vaccines. These pathways have significantly reduced the standard review time limit from 200 working days to 130 days, and even further to 70 days for medicines with urgent clinical demands and overseas approval.

In 2023, the NMPA completed 110 drug approval applications under the priority review pathway, representing a 29% increase from the previous year. Since the update of China's drug registration and administrative rules in 2020, a total of 496 drug approval applications have been placed under this program, with 42.54% of these drugs targeting cancer treatment.

Furthermore, China approved lecanemab for Alzheimer's disease in 2023, becoming the third country in the world to grant approval for this antibody treatment. Recognizing the aging population, the NMPA has drafted technical evaluation standards for Alzheimer's disease treatment products and approved clinical trials for eight innovative drugs targeting the disease in the past two years.