Cancer drug development in China: recent advances and future challenges

Abstract

Over the past 10 years, the Chinese Government, academic organizations, and biopharmaceutical companies have tried to transition the nation from a consumer of generic drugs into a developer of innovative therapies. Here, we present a timeline of recent innovative cancer drug development, with a particular focus on four case studies that have reshaped perceptions of what can be done in China. We present metrics comparing China with other countries alongside analysis of what national authorities are doing to close the gap in areas where China still lags behind the West.

Global liver disease burdens and research trends: Analysis from a Chinese perspective

“…6), the Chinese government has taken action to formulate laws more conducive to innovations in drug development, with a clear goal of discovering 100 new drugs by 2020. 49 It is also noteworthy that in recent years, cardiovascular, diabetic, oncologic, and orphan drugs constitute the majority of new entities and biologics approved by the CFDA, the FDA, the EMA, and the PMDA, which reflects the importance of policy-market interplay. Conversely, a lack of approved new drugs for liver diseases, especially metabolic liver diseases, mirrors the predicament of related research.…”

Challenges and Opportunities With Oncology Drug Development in China

“…A further regulatory barrier in China is the tremendous backlog of pending drug approvals due to the large volume of NDAs, numerous applications for generic drugs, and insufficient staff at the CFDA, leading to “waiting queues” that averaged 14 months in the years 2013 to 2015 . Given that China traditionally focused on developing generic drugs, insufficient prioritization of innovative agents has also led to delays in the approval of newer oncology TKIs and biologics…”

Novel targeted agents for the treatment of lung cancer in China

“…Although the number of early-phase trials in China has tripled in recent years and the number of new antitumor agents submitted for approval within the last year has increased, the majority of these agents were developed based on the adjusted structures or the same mechanism as those used for drug development by international companies. 55,56 The capability to develop innovative agents remains weak because of the limited awareness of risk and complexity and the lack of an overall clinical development strategy for innovative domestic drugs. Since the lung cancer genomic landscape was revealed, more targetable driven genes with a low incidence will continue to be discovered.…”