In January, two drugs received Priority Review designation from the China National Medical Products Administration (NMPA). One was BeiGene’s siltuximab, which is indicated for idiopathic multicentric Castleman’s disease (iMCD), a rare condition of the lymph nodes. The other was Alphamab Oncology’s envafolimab, which is indicated for colorectal cancer, gastric cancer and solid tumours.
Priority Review is a fast-track regulatory programme that reduces regulatory review and approval timelines for innovative drugs with significant clinical advantages and for which there is an urgent clinical need.
In recent years, China has reformed its regulatory system to include various fast-track programmes similar to the US, EU and Japan, in order to incentivise the development of drugs for unmet medical needs and serious conditions. In addition to Priority Review, this includes programmes such as Breakthrough Therapy and Accelerated Approval.
The Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate a substantial improvement over available therapy on a clinically significant endpoint. The Accelerated Approval programme allows for earlier approval of drugs that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint.
Information about China’s Accelerated Approval, Breakthrough Therapy and Priority Review designations can be obtained from GlobalData’s Pharma Intelligence Centre Drugs Database.
According to GlobalData’s Pharma Intelligence Centre Drugs database, more than 50 drugs have been granted Priority Review status by the NMPA since 2017. The majority of companies that have been granted Priority Review designation for their drugs are based in China (see Figure 1). Only a few companies based outside of China have been granted Priority Review status by the NMPA for their drug applications. Most of the drugs from non-Chinese companies that received this status had already received approvals in other markets, which suggests that this designation is making a limited contribution to the development of new drugs.
Marketed drugs that have received Priority Review include the Swiss-headquartered Roche’s atezolizumab, which is indicated for the rare liver cancer hepatocellular carcinoma, and UK-based AstraZeneca’s olaparib, which is indicated for metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer.
China has continually changed their regulatory frameworks and guidelines over the last two decades to reduce drug approval timelines and to make the Chinese market more accessible to international drug manufacturers. China’s adoption of fast-track programmes aims to expedite access to promising new therapies for serious conditions and expand access to China’s biopharmaceutical market.
