Measure on innovation efficiency of China's pharmaceutical manufacturing industry

Zhong, Shen; Liang, Shijie; Zhong, Yisheng; Zheng, Yuanyuan; Wang, Fengjun

doi:10.3389/fpubh.2022.1024997

Cited by 11 publications

(9 citation statements)

References 32 publications

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“…Delayed access to cutting-edge technologies will compromise patient health, and raise the opportunity cost of inferior therapies, which is the loss of health benefits derived from these new technologies. Notwithstanding that the pharmaceutical industry in China is growing rapidly ( McCall, 2021 ; Zhong et al, 2022 ), me-too innovations dominate the domestic companies ( Li et al, 2022 ; Zhang et al, 2023 ). First-in-class new drugs still resort to imported products.…”

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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“…Kaitelidou et al (2016) studied the innovation efficiency of public hospitals. Zhang and Yu (2019) studied the innovation efficiency of the medical device industry; Lai and Shi (2021) and Zhong et al (2022) studied the innovation efficiency of the pharmaceutical industry.…”

Section: Literature Reviewmentioning

confidence: 99%

Change and convergence of innovation efficiency among listed health companies in China: Empirical study based on the DEA–Malmquist model

Han

Hua²,

Huang³

et al. 2023

Front. Psychol.

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This study investigates the present situation of and changing trend in the innovation efficiency of health industry enterprises in China. Based on panel data for 192 listed health companies in China from 2015 to 2020, we analyse innovation efficiency using the DEA–Malmquist index and test convergence using σ-convergence and β-convergence models. From 2016 to 2019, comprehensive average innovation efficiency increased from 0.6207 to 0.7220 and average innovation efficiency decreased significantly in 2020. The average Malmquist index was 1.072. Innovation efficiency in China as a whole, North China, South China, and Northwest China showed σ-convergence. Except for the Northwest region, absolute β-convergence was evident, and in China as a whole, North China, Northeast China, East China, and South China, conditional β-convergence was evident. Overall innovation efficiency of these companies has increased annually but needs further improvement, and the COVID-19 pandemic has had a great negative impact on it. Innovation efficiency and trends in it vary across regions. Furthermore, we should pay attention to the impacts of innovation infrastructure and government scientific and technological support on innovation efficiency.

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“…В период пандемии китайская компания «Sinopharm» проводила клинические испытания своей вакцины совместно с российскими исследователями из компании «Петровакс». А Российский фонд прямых инвестиций подписал контракты с тремя китайскими компаниями по производству в Китае более 260 млн доз российской вакцины «Спутник V» 12 .…”

Section: Original Articleunclassified

“…URL: https://biocad.ru/news/vkitae-startovalo-klinicheskoe-issledovanie-originalnogorossijskogo-preparata-dlya-terapii-raka-shejki-matki. 12 Китай называет фармацевтическое сотрудничество с Россией новой точкой роста // Фарммедпром. URL: https://pharmmedprom.ru/news/kitai-nazivaet-farmatsevticheskoe-sotrudnichestvo-s-rossiei-novoi-tochkoi-rosta/.…”

Section: Original Articleunclassified

Comparative Analysis of Pharmaceutical Industry of Russia and China. Prospects for Cooperation

Vorontsova

2023

Russian and Chinese Studies

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The purpose of the study is to determine the prospects for cooperation between Russia and China in the development of the pharmaceutical industry based on a comparative analysis of pharmaceutical markets, healthcare systems, regulations, as well as the specifics of the production of pharmaceuticals. Russia and China have similar pharmaceutical markets characterized by the dominance of local companies, low pricing, and high state intervention. However, China's pharmaceutical market is more developed, larger, and more diversified than Russia's. China has a better-funded healthcare system, more favorable regulations, and higher intellectual property protection. China's research and development capabilities are also more advanced, with a higher number of clinical trials, patents, and scientific publications. Russia and China have similar pharmaceutical markets characterized by dominance by local companies, low prices and high levels of government intervention. The Chinese market is much larger, more developed and diversified than the Russian one. And while it continues to face uncertainty amid drug pricing issues and low levels of intellectual property protection, China continues to be one of the most attractive investment destinations in the Asia-Pacific region. However, Russia has a more stable political environment, a well-developed scientific base and highly qualified personnel. The Russian Federation also has a favorable geographical position for logistics and exports. In recent years, the pharmaceutical industry in Russia and China has undergone significant changes, which has led to an increase in global competitiveness. The article analyzes the current state of the pharmaceutical industry of the two countries, highlights the key trends and prospects for cooperation in the future. While both countries have growth potential, there are notable differences in their strengths and weaknesses that may influence future market strategies. In general, the potential for cooperation between Russia and China is great, especially given the current opportunities for expanding international trade and investment.

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Measure on innovation efficiency of China's pharmaceutical manufacturing industry

Cited by 11 publications

References 32 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

Change and convergence of innovation efficiency among listed health companies in China: Empirical study based on the DEA–Malmquist model

Comparative Analysis of Pharmaceutical Industry of Russia and China. Prospects for Cooperation

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