Measures facilitate approval of 48 first-in-class innovative drugs

China approved 48 first-in-class innovative drugs, as well as a significant number of medications for pediatric and rare diseases, thanks to measures aimed at enhancing review efficiency and accelerating patient access to novel therapies, according to a report released on Tuesday by the National Medical Products Administration.

The 48 innovative drugs cover nearly 20 therapeutic areas, including oncology, neurological disorders and anti-infective medicines, the report said. The number was the highest in the past five years, compared with 40 in 2023 and 21 in 2022.

Among them, 17 received market approval through a priority review pathway, 11 gained conditional market approval and 13 were included in breakthrough therapy programs during clinical trials, according to the report from the administration's drug evaluation center.

"The center is guided by clinical value and has implemented various measures to enhance review efficiency and expedite approval of new and effective drugs, so as to provide patients with a broader range of medication options," the report said.

In addition, China approved 106 pediatric medicines, and 35 medications were granted expanded pediatric indications, which is expected to help alleviate the shortage of pediatric medication options, the report said.

Furthermore, 55 rare disease medicines were authorized for market last year.

To speed up drug approvals, the administration has set up four accelerated pathways, Yuan Lijia, an official at the center, said in an interview with China Central Television.

These pathways include the priority review program, which targets medicines in urgent need or those that treat major infectious diseases and rare diseases, as well as upgraded new drugs, pediatric medications and innovative vaccines.

Through the program, the standard review time limit of 200 working days is shortened to 130. For medicines that meet urgent clinical demands and have been approved overseas, the time limit is further reduced to 70 days.

"In 2024, the administration completed 110 drug approval applications covering 74 different categories under the priority review pathway, marking a year-on-year increase of 29 percent," Yuan said.

Since China updated its drug registration and administrative rules in 2020, 496 drug approval applications have been placed under the priority review program, with 42.54 percent treating cancer.

Last year also saw China approving lecanemab for Alzheimer's disease, an antibody treatment believed to be the world's first to slow progression of the memory-robbing disease in its early stages. China was the third country to grant approval for the treatment, following the United States and Japan.

As the population continues to age rapidly, the administration said it has drafted technical evaluation standards for Alzheimer's disease treatment products. In the past two years, it has approved clinical trials for eight innovative drugs that could potentially treat the disease.