Drug Review Report 2023: calling attention to 5.1 chemicals IND

On February 4, the?Center of Drug Evaluation?(CDE) released its?2023 Drug Review Report, providing a summary of 2023's drug and clinical trial reviews and approvals, and highlighting government priorities with regards to new drugs.?

Strong rebound as record number of new drugs approved in 2023?

In 2023, CDE approved the largest number of new drugs in a single year. According to the 2023 Drug Review Report, a total of 126 new drugs were approved in 2023, compared to 104 in 2022. Unlike "class 1 innovative drugs,” which only include drugs of which China was the first country it was approved in, “new drugs” refer to both class 1 innovative drugs and imported originators classified as 5.1 chemical drugs and 3.1 biological drugs. After already performing well in 2022, the number of imported originators receiving approval reached a new record in 2023.?

Applications show upward trend, with exceptions??

Increased new drug approvals come on the back of increased applications across the board from 2022 to 2023. For example, CDE accepted 13,621 applications for preparations in 2022, which increased by 36.63 percent to 16,898 in 2023, the highest on record. The large number of new applications for preparations led to an increase in administrative approvals and pending technical evaluation approvals. These increases all point to thriving pharmaceutical R&D activity.?

While 2023 saw a rebound in the number of overall applications that were submitted, as well as in the number of imported originators that were approved, a different picture emerged for investigational new drugs (INDs) and new drug applications (NDAs) related to imported originators. There were?130 applications for imported originators’ INDs and NDAs, down 10.96 percent from 2022. In 2023, INDs of imported originators decreased by 18 percent to 32, and NDAs by 8 percent to 98. Although imported originators' NDAs remained relatively high, they seem to be losing momentum when compared to domestic novel chemicals which are rapidly making gains in 2023. Imported originators' INDs are not only falling behind domestic chemical drugs but are also showing a downward trend over the last five years.?

New drugs for rare diseases and the pediatric population?

In recent years, NMPA has worked hard at encouraging the industry to develop new drugs to satisfy unmet clinical needs, emphasising rare disease and pediatric drugs.

In September 2023, the Second Rare Disease Catalogue, containing 86 diseases, was released, bringing the total number of listed rare diseases in China to 207. These diseases are prioritised in terms of market access and NRDL listing. In 2023, 45 new drugs were approved for rare diseases, the largest number of new drugs for rare diseases approved in a single year. Among the 15 rare disease drugs that won approval via the priority review and approval pathway, 10 were imported originators.

Since 2016, four lists containing 135 encouraged pediatric drugs were released to encourage the R&D of drug forms, indications, and dosages specifically for children. These efforts bore fruit: 92 pediatric drugs were approved in 2023. Among the 26 pediatric drugs approved via the priority review and approval pathway, 17 were imported originators.??

Additionally, CDE approved 10 and 12 drugs on the official encouraged lists in 2022 and 2023, respectively. According to the CDE report, a total of 45 drugs on the encouraged list were approved over the past five years. These drugs cover eight therapeutic areas, including the nervous system, endocrine system, and oncology.

Conclusion?

While the number of overall applications bounced back strongly, showing an upward trend in 2023, imported originators' INDs and NDAs did not follow the same growth trajectory. Although NDAs of imported originators still performed well, the number of INDs decreased. However, imported originators contribute significantly to the treatment of rare diseases and pediatric diseases, two priority areas in government policy.?