Trends and Characteristics of New Drug Approvals in China, 2011–2021

Su, Ling; Liu, Sen; Li, Guanqiao; Xie, Cuicui; Yang, Huan; Liu, Yang; Chen, Yin; Chen, Xiaoyuan

doi:10.1007/s43441-022-00472-3

Cited by 11 publications

(6 citation statements)

References 14 publications

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“…The Chinese government has issued the lists of Urgently Needed Overseas Drugs to call for drug applications ( Li et al, 2021b ). Drugs on the lists are eligible for expedited review pathways ( Su et al, 2023 ). However, the present lists contain a limited number of drugs; and unlike the orphan designation of the FDA ( U.S. Food and Drug Administration, 2022 ), the lists do not involve favorable policies for financial support and market exclusivity.…”

Section: Discussionmentioning

confidence: 99%

Bridging the new drug access gap between China and the United States and its related policies

Zhu,

Chen

2024

Front. Pharmacol.

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Introduction: The access gap for novel pharmaceuticals between China and the developed countries is a major public health issue in China. It is crucial to understand the determinants of this gap to ensure timely access to new drugs and enhance patient health.Methods: We included all new drugs approved by the US Food and Drug Administration (FDA) between 2012 and 2019, and collected their approval timings in China. Major factors of interest comprised orphan designation and expedited review pathways granted by the FDA, along with the proportion of Asian subjects in the pivotal trial supporting the FDA approval and whether the trial included study sites in China. The elapsed time from the FDA approval to the market authorization in China constituted the time-to-event outcome, and Cox proportional-hazards regression was used for multivariate analysis.Results: A total of 327 new drugs were approved by the FDA between 2012 and 2019, among which 41.3% were found to be authorized in China as of 1 November 2023. The median lag time for the mutually approved drugs was 3.5 years. The Cox model found that orphan drugs had lower likelihood of being approved in China (HR = 0.59, 95% CI 0.39–0.89; p = 0.011), while the FDA’s Breakthrough-Therapy drugs (HR = 2.33, 95% CI 1.39–3.89; p = 0.001) and Fast-Track drugs (HR = 1.58, 95% CI 1.05–2.38; p = 0.028) had shorter lag times. In the pivotal trials that supported the FDA approvals, a higher proportion of Asian subjects was associated with faster drug entry into the Chinese market (HR = 1.02, 95% CI 1.01–1.03; p < 0.001), and the inclusion of study sites in China mainland was likewise conducive to reducing the drug lag (HR = 5.30, 95% CI 3.20–8.77; p < 0.001). After the trials with China-based sites supported the FDA approvals, 77.8% of the trials also supported the subsequent approvals in China.Discussion: China’s involvement in global drug co-development can streamline clinical development, by reducing repeated trials solely in the Chinese population. This is primarily due to the openness of the Chinese drug agency towards overseas clinical data and is a positive sign that encourages global drug developers to include Chinese patients in their development plans as early as possible.

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Section: Discussionmentioning

confidence: 99%

Bridging the new drug access gap between China and the United States and its related policies

Zhu,

Chen

2024

Front. Pharmacol.

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“…In the process, we found some drugs with different acceptance numbers because they had different specifications. However, according to the relevant descriptions in the Drug Review Reports issued by CDE and the practice in several literature, the same drug with different specifications declared by the same company at the same time was recognized as one ( Chen et al, 2022 ; Luo et al, 2023 ; Su et al, 2023 ). Therefore, in this paper, the statistics were also conducted in this way.…”

Section: Methodsmentioning

confidence: 99%

Assessment of the implementation of accelerated drug marketing registration procedures for antineoplastic and immunomodulating agents in China: based on 2016–2022 review data

Lan,

Lin,

et al. 2024

Front. Pharmacol.

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Objective:Since 2016, China has successively implemented Accelerated Drug Marketing Registration Procedures (ADMRPs) for drugs, including Breakthrough Therapy Drug (BTD), Conditional Approval (CA), and Priority Review and Approval (PRA), which have played an important role in promoting the development and review of clinically urgently needed drugs. In this study, we focused on the antineoplastic and immunomodulating agents approved for marketing through ADMRPs, to provide a reference for promoting the formation of a stable and mature regulatory system for the review and approval of antineoplastic drugs and immunomodulating agents in China.Methods:Reviewed the National Medical Products Administration (NMPA) drug review reports for the years 2016–2022 and screened the antineoplastic and immunomodulating agents approved through ADMRPs. Then, with the help of the NMPA website and the Yaozhi Database, two researchers independently queried and entered the detailed information of the selected drugs, and checked with each other. The attribute classification and main characteristics of the drugs were then analyzed with descriptive statistics to obtain the trend of drug types, drug review and approval status, and timeliness.Results:A total of 206 antineoplastic and immunomodulating agents were approved for marketing through five accelerated marketing registration procedures (or procedure combinations), with the average review time shortened by about 81 days. Among them, imported drugs accounted for a larger proportion, the most drugs for treating non-small cell lung cancer and lymphoma, and the largest number of PD-1/PDL-1 inhibitors, but pediatric drugs and rare disease drugs accounted for a smaller proportion.Conclusion:ADMRPs can promote the accessibility of antineoplastic and immunomodulating agents in China and safeguard the life and health rights of more patients. Nevertheless, it is necessary to pay attention to the expansion of the types of indications for medicines and to increase the development of drugs that are urgently needed by a small number of patients.

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“…In the past, the large backlog of new drug applications in the Chinese regulatory agency and stringent clinical trial approval requirements led to significant delays in new drug approvals compared with European and American countries. 4 According to the Annual Drug Evaluation Report for the Year 2015, in September 2015, the Center for Drug Evaluation (CDE) had a backlog of over 22,000 drug evaluation tasks. Between 2013 and 2015, the average delay in the evaluation and approval of clinical trial applications for innovative drugs in China was 14 months.…”

Section: What Does This Study Add To Our Knowledge?mentioning

confidence: 99%

“…Similar to Japan, China is also an Asian country. In the past, the large backlog of new drug applications in the Chinese regulatory agency and stringent clinical trial approval requirements led to significant delays in new drug approvals compared with European and American countries 4 . According to the Annual Drug Evaluation Report for the Year 2015, in September 2015, the Center for Drug Evaluation (CDE) had a backlog of over 22,000 drug evaluation tasks.…”

mentioning

confidence: 99%

The Impact of Regulatory Reforms in China on Drug Lag: The Role of Clinical Development Strategies

Han,

Jiang,

et al. 2024

Clin Pharma and Therapeutics

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In recent years, there has been significant focus on China's new drug lag, but relevant research is limited. This study explores the reasons for drug lag by assessing the impact of reforms in China's drug review system, particularly focusing on the influence of clinical development strategies. This study selected drugs first launched in the United States between 2017 and 2022, examining absolute and relative lag between China and the first‐launch country (including submission and review lag). These delays with drugs approved in the European Union and Japan during the same period were compared with uncover the roots of delays in China, further identifying potential factors that could reduce these delays. The results indicate that the National Medical Products Administration (NMPA) has a longer relative lag compared with the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA). The submission lag time of the NMPA significantly surpasses that of the EMA and PMDA, whereas the review lag time of the NMPA exceeds that of the PMDA but falls short of the EMA. Focusing on clinical trial strategies, bridging trials and multiregional clinical trials (MRCTs) are typically required by the NMPA in East Asia, resulting in longer clinical delay time. Whereas the EMA and PMDA primarily require international MRCTs in Europe and America, with a clinical delay of < 5 months. It is evident that there is a significant gap in clinical trial durations between China and other countries. Further optimization of clinical trial management is necessary to address the lag for new drugs in China.

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Trends and Characteristics of New Drug Approvals in China, 2011–2021

Cited by 11 publications

References 14 publications

Bridging the new drug access gap between China and the United States and its related policies

Bridging the new drug access gap between China and the United States and its related policies

Assessment of the implementation of accelerated drug marketing registration procedures for antineoplastic and immunomodulating agents in China: based on 2016–2022 review data

The Impact of Regulatory Reforms in China on Drug Lag: The Role of Clinical Development Strategies

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