Anti-tumor drug supervision in China from 2010 to 2024: the evolution and prospect of drug review standards

Abstract

Over the past decade, the research and development (R&D) of anti-tumor drugs in China has undergone a remarkable leap, maintaining a high level of motivation.

With respect to pharmaceutical R&D paradigms in China, the domestic market was once dominated by generic drugs. A progressive transition towards the development of innovative pharmaceuticals is emerging, consequent to the reforms in drug evaluation and approval mechanisms and the promotion of novel drug development in China. The introduction of new drugs from other countries to China used to lag behind. Now a progressive approach is being taken towards synchronization in global R&D. The emergence of new players in the pharmaceutical industry and the enhancement of corporate R&D competencies have further facilitated the internationalization of China's drug R&D endeavors. The rapid advancement in pharmaceutical R&D has significantly enhanced China's drug regulatory capabilities. In August 2015, the State Council of the People's Republic of China promulgated the “Opinions on Reforming the Approval Procedures for Drugs and Medical Devices” marking the official commencement of reforms in the drug evaluation and approval system. The Chinese drug regulatory authorities are integrating resources and optimizing drug review processes through the development of a scientifically complete system of Good Review Practice.

Innovative drugs, including new drugs, improved new drugs (those improved formulations or dose forms with existing active ingredients), biosimilars, and domestic generic drugs with unimported original drugs, constitute essential assurances for patients in China and offer better accessibility of medications. To better understand the changes since the inception of the drug evaluation and approval reforms in 2015, we have collected data on new drug applications (NDAs) for the aforementioned types of drugs submitted to the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China, spanning from January 2010 to March 2024.

A total of 374 NDAs for anti-tumor drugs had been approved from January 1, 2010 to March 31, 2024, including 186 (49.7%) imported drugs and 188 (50.3%) domestic drugs. The domestic drugs included 139 (37.1%) innovative/improved new drugs, 31 (8.3%) generic drugs, and 18 (4.8%) biosimilars, respectively.

Before 2018, China's pharmaceutical market mainly relied on domestic generic drugs. However, since 2018, the number of drug authorizations granted to innovative drugs has been on the rise, with a notable increase in domestically developed innovative drugs (Figure 1). The emergence of an upward trend in domestically R&D innovative drugs is due to better regulatory frameworks, faster review processes, and the introduction of technical standards. The Chinese government has implemented policies promoting anti-tumor drug R&D, including priority review, conditional approval, and breakthrough treatment designation. From 2010 to 2015, the CDE approved 45 anti-tumor drugs with an average review time of 580 days. From 2016 to 2024, the average review time for 329 applications dropped to 280.2 days. These measures enhanced review efficiency and transparency, offered a more predictable environment for drug development, and boosted the industry's confidence and interest in R&D.

The advent of these domestic drugs has addressed much of the unmet needs of Chinese patients, transformed tumor therapeutics profoundly, and achieved success in the international market, thereby providing additional treatment options for patients worldwide. Bruton's tyrosine kinase inhibitor Zanubrutinib (Brukinsa®), which was granted an accelerated approval by the United States (US) Food and Drug Administration (FDA) in 2019, was tested in a pivotal study—a single-arm trial (SAT) —conducted in Chinese patients after consultation with the CDE to reach consensus.

Since 2012, the CDE has issued 61 guidance to support anti-tumor drug R&D and address the technical challenges. This has contributed to the improvement of anti-tumor drug review framework in China.

Since China started the reforms in the drug review and approval system in 2015, the number of approvals of new drugs has been on the rise, with a steady increase in the number of applications that are globally synchronized. These achievements have reduced the disparity between domestic and international clinical practices, allowing Chinese patients to receive advanced therapeutic drugs and making it easier for pharmaceutical companies to synchronize global R&D strategies.

The accelerated R&D and launch of new drugs will ultimately reshape the landscape of tumor therapies, bringing more and diverse treatment options to patients in China. Moving forward, China's drug regulatory authorities are committed to advancing regulatory innovation for anti-tumor drugs to align with the evolving clinical treatment needs and drug R&D demands. We will introduce and integrate advanced international evaluation methods to refine the drug approval process. Regulatory innovation will prioritize the drugs targeting rare and pediatric tumors. We aim to enhance R&D efficiency and facilitate effective treatments through policy support. Additionally, we will promote the convergence of R&D and clinical application of anti-tumor drugs to advance China's anti-tumor drug industry. China's drug regulatory authorities will remain committed to offering a greater number of high-quality, safe, and effective therapeutic drugs for cancer patients.

Research concept and design: Jun Ma and Zhimin Yang. Collection and/or assembly of data and policy: Ling Tang, Yuanyuan Song. Analysis and interpretation of data and policy: Ling Tang, Yuanyuan Song, Hong Zhang, Ruimin Hao, Xin Tong, Xing Ai. Article written: Ling Tang. All authors approved the final manuscript.

The authors declare that they have no conflicts of interest.

Not applicable.

Not applicable.