China Approves Record 48 First-in-Class Innovative Drugs in 2023
核心洞察
China's National Medical Products Administration (搜索) approved 48 first-in-class innovative drugs in 2023, the highest number in five years, covering nearly 20 therapeutic areas including oncology (搜索) and neurological disorders (搜索).
Accelerated approval pathways helped expedite patient access to novel therapies, with 17 drugs receiving market approval through priority review, 11 gaining conditional approval, and 13 included in breakthrough therapy programs.
The administration also approved 106 pediatric medicines, expanded indications for 35 medications, and authorized 55 rare disease treatments, addressing critical gaps in the treatment landscape.
China's drug regulatory authority has achieved a significant milestone in pharmaceutical innovation, approving a record number of novel therapies while implementing measures to accelerate patient access to cutting-edge treatments.
Record Number of First-in-Class Approvals
The National Medical Products Administration (搜索) (NMPA) approved 48 first-in-class innovative drugs in 2023, marking the highest number in the past five years, according to a report released Tuesday. This represents a substantial increase from 40 approvals in 2022 and 21 in 2021.
These novel therapies span nearly 20 therapeutic areas, including oncology (搜索), neurological disorders (搜索), endocrine diseases (搜索), and anti-infective medicines, significantly expanding treatment options for Chinese patients.
Of the 48 innovative drugs, 17 received market approval through priority review pathways, 11 gained conditional market approval, and 13 were included in breakthrough therapy programs during clinical trials.
"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," stated the report from the administration's drug evaluation center.
Accelerated Approval Pathways Driving Innovation
To expedite drug approvals, the NMPA has established four accelerated pathways, according to Yuan Lijia, an official at the center. These include the priority review program targeting medicines in urgent clinical need, treatments for major infectious diseases and rare conditions, upgraded new drugs, pediatric medications, and innovative vaccines.
Through these accelerated programs, the standard review time of 200 working days has been reduced to 130 days. For medicines meeting urgent clinical demands that have already received overseas approval, the timeline is further shortened to just 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 noted.
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.
Addressing Critical Treatment Gaps
The NMPA's efforts have also focused on addressing significant gaps in the treatment landscape. Last year, China approved 106 pediatric medicines and expanded indications for 35 existing medications, helping to alleviate the shortage of pediatric treatment options.
Additionally, 55 rare disease medicines received authorization, providing hope for patients with conditions that often lack effective therapies.
In a notable achievement, China became the third country globally, after the United States and Japan, to approve lecanemab for Alzheimer's disease (搜索). This antibody treatment is considered the world's first to slow progression of the memory-robbing disease in its early stages.
Focus on Aging Population Needs
With China's rapidly aging population, the NMPA has prioritized treatments for age-related conditions. The administration has drafted technical evaluation standards specifically for Alzheimer's disease (搜索) treatment products.
Over the past two years, it has approved clinical trials for eight innovative drugs that could potentially treat Alzheimer's disease (搜索), demonstrating a forward-looking approach to addressing the healthcare challenges of an aging society.
These regulatory advancements reflect China's growing commitment to pharmaceutical innovation and improving patient access to novel therapies across multiple therapeutic areas.