China's fast-track regulatory reforms face difficulties in attracting non-Chinese companies

China has reformed its regulatory system in recent years to include various fast-track programs similar to the US, EU, and Japan to incentivize the development of drugs for unmet medical needs and serious conditions. However, only a few companies based outside of China have been granted priority review status by the National Medical Products Administration (NMPA) for their drug applications, says GlobalData, a leading data and analytics company.

Reportedly, more than 50 drugs have been granted priority review status by NMPA since 2017, out of which most of the drugs belong to China-based companies.

Keshalini Sabaratnam, PhD, Analyst, Drugs Database at GlobalData, comments: “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.”

The 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 Plc’s olaparib, which is indicated for metastatic hormone-refractory (castration-resistant, androgen-independent) prostate cancer.

In January 2021, two drugs received priority review designation from China’s NMPA: BeiGene’s siltuximab, which is indicated for idiopathic multicentric Castleman’s disease (iMCD), a rare condition of the lymph nodes; and Alphamab Oncology’s envafolimab, which is indicated for colorectal cancer, gastric cancer, and solid tumor.

Ms Sabaratnam concludes: “China has continually changed its 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 programs aims to expedite access to promising new therapies for serious conditions and expand access to China’s Bio/Pharma market.”