China – New Drug Approvals in China in 2019

In 2019, China’s National Medical Products Administration (NMPA) granted marketing approvals to 34 new chemical drugs and 19 biological products. Among the approvals, oncology drugs, anti-inflammatory drugs, and drugs for the immune system are the top three therapeutic areas.

The NMPA defines Category 1 innovative drugs as drugs not approved anywhere in world. In 2019, 12 of the 53 new drug approvals were Category 1 innovative drugs, including eight chemical drugs and four biologics. All but one were developed by local Chinese pharmaceutical and biotechnology companies. The imported one was Dacomitinib, as an imported Category 1 product. Dacomitinib, developed simultaneously both in China and abroad, was approved by the US FDA in September 2018 and by China’s NMPA in May 2019.Comparing the number of Category 1 drugs approved over the last five years, Figure 1 shows that there were only a few approvals between 2015 and 2017. New Drug Applications of Category 1 innovative drugs began to increase in 2017, with 11 filed in that year. The number of Category 1 approvals increased substantially in 2018 and reached a new record in 2019. This is an early sign of initial achievements in the local Chinese pharmaceutical industry’s R&D efforts in novel drug discovery and development, particularly propelled by a series of government policies encouraging innovation in recent years. It is expected that more innovative drugs will be approved and potential breakthroughs may emerge in China in the near future…