IntroductionUnder the background that economic policy uncertainty tends to be normal, the innovation behavior of enterprises can cope with the cost impact brought by economic policy uncertainty.MethodsBased on the relevant data of China’s A-share pharmaceutical listed companies from 2015 to 2022, this paper empirically studied the relationship between economic policy uncertainty and firm innovation by using fixed-effect model, intermediary model, instrumental variable method and two-step method, and investigated the mechanism effects of financialization, executive compensation and government subsidies.ConclusionEconomic policy uncertainty significantly increases the innovation intensity of enterprises. Enterprises with dual management, overseas background and non-state-owned ownership will increase their innovative behavior in the face of economic policy uncertainty. Further analysis shows that economic policy uncertainty increases the innovation intensity of enterprises through three mechanisms: increasing financial transformation, obtaining government subsidies and motivating management. Increasing the innovation intensity of enterprises can deal with the risk impact caused by economic policy uncertainty, but can not deal with the negative impact of cost increase. The transformation of financialization can help enterprises cope with the operational risks and later costs caused by economic policy uncertainty.DiscussionThis study provides empirical evidence for the theoretical inference that firms respond to the impact of economic policy uncertainty and thus increase their innovation behavior.

Environmental, social and governance performance is an important driver for companies to achieve innovative and high-quality development, and the relationship between sustainable development and corporate innovation is one of the key concerns of pharmaceutical companies. This study aims to reveal the intrinsic role mechanism of sustainable transformation of pharmaceutical enterprises in high-quality innovation development. Based on the relevant data of China's A-share pharmaceutical listed companies from 2015 to 2022, the study establishes a fixed effect model and a mediation effect model, empirically examines the impact of ESG performance on the innovation of pharmaceutical listed companies, and deeply explores the role mechanism of R&D personnel investment and government subsidies in it. The study finds that: (1) ESG performance significantly enhances firms' innovation inputs and green innovation outputs; (2) this facilitating effect is more substantial among non-state-owned firms and firms in the eastern region; (3) good ESG performance has a more pronounced facilitating effect on innovation inputs of large firms, while it has a more prominent effect on the green innovation outputs of small and medium-sized firms; and (4) the mechanism analysis indicates that internal R&D personnel investment and external government subsidies play a significant mediating effect between ESG performance and corporate innovation. This study provides new empirical evidence for understanding the mechanism of ESG performance on corporate innovation in Chinese pharmaceutical companies. It provides theoretical support for proactively promoting the sustainable transformation and deepening the development of green innovation in Chinese pharmaceutical companies. In addition, there are important policy implications for promoting the sustainable transformation of pharmaceutical companies: the establishment of differentiated ESG incentive policies, the improvement of R&D talent training mechanisms, and the optimization of government subsidy allocations, focusing on supporting green innovation by companies with excellent ESG performance.

Enterprise innovation investment is influenced by the actions of innovation subjects, whereas regulating shareholders’ equity pledge behavior facilitates innovation investment and finance but also carries dangers and affects enterprise innovation investment. Methods:This paper builds an unbalanced panel model to empirically analyze the impact of controlling shareholders’ equity pledges on corporate innovation and its heterogeneous characteristics. It also looks at the moderating role of corporate financing constraints and the mediating role of equity incentives, using data from A-share listed companies in China’s pharmaceutical manufacturing industry from 2015 to 2022. Innovation investment is substantially inversely correlated with controlling shareholders’ equity pledge; that is, firms’ creative behavior and intensity are inhibited by equity pledge. Results and conclusions:The results also show that controlling shareholders’ equity commitments have a more pronounced negative impact on enterprises’ ability to innovate than non-state-owned and decentralized equity firms. The relationship between company innovation and the equity pledge of controlling shareholders is somewhat mediated by equity incentives. The relationship between controlling shareholders’ equity promises and enterprises’ innovation is negatively moderated by financing limitations, which also reduces R&D expenditure and stifles innovation.

IntroductionIn October 2017, China initiated adjustments to the registration procedures for imported drugs to promote accessibility to overseas drugs. In support of this decision, the National Medical Products Administration (NMPA) issued a technical guideline regarding accepting foreign clinical trial data in July 2018. Collectively referred to as the accepting foreign clinical data policy, these measures have accelerated the influx of overseas drugs into China.MethodsUsing the panel data from 104 A-share pharmaceutical listed firms between 2013 and 2024, this study conducted a difference-in-differences model to explore the impact of this policy on the innovation investment of Chinese pharmaceutical firms and further analyzed the underlying moderating effect.ResultsThe results demonstrate a significantly positive effect of this accepting foreign clinical data policy on pharmaceutical firms’ innovation investment, which is verified with the parallel trend and robustness tests. Further analysis indicates that corporate absorptive capacity positively moderates the relationship between the policy implementation and innovation investment. In addition, the heterogeneity analysis suggests that this policy has a more significant effect on firms that are non-state-owned, engage in new drug research and have strong market power.DiscussionThis study serves as a significant supplement to the current literature regarding the accepting foreign clinical data policy and innovation investment, providing valuable insights for policymakers and R&D decision-makers in the pharmaceutical sector.

Digital inclusive finance, with ‘universality’ as its core feature, can stimulate enterprises to increase capital investment in research and development (R&D) through diversified channels. Using the digital financial inclusion index of 337 prefecture-level cities in China and the empirical data of Shanghai and Shenzhen A-share-listed pharmaceutical manufacturing enterprises from 2011 to 2022, the article empirically examines the impact mechanism of digital financial inclusion on R&D investment of pharmaceutical manufacturing enterprises from the perspective of government subsidy by using a high-dimensional fixed-effects model, a two-stage systematic GMM, and a moderated-effects test method. It is found that digital financial inclusion has a positive incentive effect on pharmaceutical manufacturing enterprises to increase R&D investment, and this positive effect still holds after the endogeneity test and robustness test. The results of the moderating effect test indicate that government subsidies play a positive moderating role in the process of digital financial inclusion affecting enterprises’ R&D investment. Further analyses show that digital financial inclusion has a more significant role in promoting the intensity of R&D investment in pharmaceutical enterprises in private enterprises, small and medium-sized enterprises, and regions with lower levels of traditional financial development. Finally, policy suggestions are put forward according to the conclusion. Including the government to promote digital infrastructure and policy support, financial institutions to build data platforms to support pharmaceutical innovation, and enterprises to increase investment in research and development and expand financing channels to jointly promote the transformation and upgrading of the industry.

BACKGROUND:In November 2015, China launched a pilot program for its Drug Marketing Authorization Holder (MAH) system, aiming to integrate production and research and development resources to spur drug innovation. While many scholars have examined the theoretical relationship between the MAH system and pharmaceutical manufacturing innovation, empirical studies have been scarce. METHODS:This study uses inter-provincial panel data on China's pharmaceutical manufacturing industry from 2009 to 2019, along with synthetic control methods, to offer a robust analysis of the impact of the MAH paradigm on innovation quality in pilot provinces. We treat the 2015 MAH system implementation in ten provinces as a natural experiment and account for the mediating effects of R&D investments, allowing us to discern the underlying mechanisms. RESULTS:Our findings demonstrate a significant positive effect of China's MAH system on innovation quality in the pharmaceutical manufacturing industry. Specifically, the system is most effective in Jiangsu, Guangdong, and Shandong provinces. We also identify R&D investments as playing a mediating role in facilitating the favorable impact of the MAH system on innovation quality. CONCLUSION:Our study highlights the crucial importance of the MAH system in promoting innovation quality in China's pharmaceutical manufacturing industry, providing vital empirical support for its adoption and further enhancement. This research also offers practical insights for policymakers and R&D decision-makers in the pharmaceutical sector.

Purpose The use of real-world evidence (RWE) in regulatory reviews and approvals is currently experiencing significant changes amid increasingly active discussions, primarily reflected in relevant policies, regulations, and guidance documents. However, disparities persist between China and the United States regarding the acceptance and formulation of policies for incorporating real-world data/evidence (RWD/E) in regulatory evaluation and authorization. Furthermore, the current policies lack specific operational details necessary for effective implementation and widespread adoption. Methods After conducting a systematic literature review and comparing relevant policies, regulations, and guidelines, as well as the related information published on their official websites, we analyze key aspects of RWE-based drug review and approval policies to highlight similarities and differences in these policies between China and the United States. Findings This paper reviews the frameworks and existing guidelines in China and the U.S., discussing similarities and differences observed in key policy aspects, including relevant definitions, data sources, data standards, data quality, and connectivity, information requirements, study design, personnel training, and communication, including an example of the application of RWE in drug review and approval processes. Implications Further develop and refine RWE policies, encourage cooperation, and share best practices and successful examples to enhance the effectiveness of policy implementation and increase its social acceptance.

In 2018, China began to gradually promote the pilot policy of centralized band purchasing of medicines. Implementing this policy has resulted in a significant decrease in drug prices. However, there needs to be a clear consensus on the impact and mechanism of action on the innovation of pharmaceutical companies. Therefore. Taking the data of Chinese Shanghai and Shenzhen A-share pharmaceutical listed companies from 2016 to 2022 as a sample, this paper empirically investigates the impact of the centralized banded purchasing policy of drugs on the innovation of pharmaceutical enterprises by using a double difference model and further analyzes the mechanism of its action. The results show that implementing the centralized banded purchasing policy can promote pharmaceutical enterprises’ innovation input and output, which is robust under the parallel trend and placebo tests. Further exploring the impact mechanism of the centralized band purchasing policy on pharmaceutical enterprises’ innovation, it can be found that it promotes innovation inputs through three channels: government subsidies, enterprise profits, and operating income. In addition, the impact of centralized band purchasing on enterprise innovation is heterogeneous in terms of region, enterprise nature, and scale. Therefore, the positive effects of the centralized band purchasing policy on promoting innovation in pharmaceutical enterprises should be fully recognized, and enterprise heterogeneity should be taken into account when implementing the policy. This study provides empirical evidence on the implementation effect of the centralized banded purchasing policy and provides lessons for continuously optimizing the policy to promote the high-quality development of pharmaceutical enterprises.

There is intense competition among pharmaceutical companies with the rapid growth of the global pharmaceutical industry. In recent years, China has continuously increased the reform of the medical system. Technology mergers and acquisitions (M&A) in China’s pharmaceutical industry have emerged in this complex policy and economic background. This paper conducts an empirical study from the dual perspectives of financial performance and innovation performance, based on unbalanced panel data of Chinese listed pharmaceutical firms from 2012 to 2022. The impact of technology M&A on firm performance is analyzed in terms of the heterogeneity of firm characteristics. Meanwhile, the relationship between R&D investment in technology M&A and firm performance is examined. The results show that technology M&A can promote the performance of pharmaceutical companies, and R&D investment has a mediating effect on the impact of technology M&A on corporate performance. Based on the above findings, this study enriches the relevant literature on technology M&A in the pharmaceutical industry, provides warnings and suggestions for pharmaceutical companies to improve corporate performance through technology M&A, and provides reference materials for future policy formulation.

Traditional Chinese medicine (TCM) is a valuable resource unique to China with a long history of human use and clinical practice, which can be analyzed to generate real-world evidence (RWE). The Chinese government has been actively promoting regulatory reform that is in line with the characteristics of TCM, optimizing the clinical evidence system for TCM, and exploring the important role of RWE in supporting the development of new drugs and regulatory decision-making for TCM. This article aims to provide a comprehensive review of the use of RWE in regulatory decisions for TCM. Based on the characteristics of TCM, this study focuses on the application scenarios, challenges, and opportunities of RWE in TCM. And some suggestions are put forward to promote the wider application of RWE in TCM development and supervision.

The relationship between financialization and innovation has become a common focus of academic attention. This paper analyzes the influence of corporate financialization on innovation efficiency based on balanced panel data of listed Chinese pharmaceutical companies from 2015 to 2020. Also, it examines the relationship between corporate financialization and innovation efficiency under different levels of financing constraints and the moderating mechanisms that exist. The results of the study show that corporate financialization negatively affects innovation efficiency and that this effect has a lag; corporate financialization hurts innovation efficiency across the different regions and firm nature, with a less inhibiting effect for eastern firms and non-state-owned firms; further tests of the mechanism of action show that there is a non-linear negative relationship between corporate financialization and innovation efficiency. And the inhibition of corporate financialization on innovation efficiency decreases as the level of financing constraints rises. Based on the above findings, this study provides warnings and recommendations for pharmaceutical companies to finance their innovative activities through financialization.

Purpose With the dawn of the digital era and the escalating severity of environmental issues. the eco-friendly growth of the pharmaceutical manufacturing industry is essential for advancing humankind's standard of living, how to convert the pharmaceutical manufacturing industry which is a re-source-intensive to a green and innovative sustainable development model urgently needs a new strategic choice. Design/methodology/approach The influence of the digital economy's level of development on the pharmaceutical manufacturing industry's green innovation performance within the context of doubling carbon emissions is empirically examined in this article, and the threshold effect of innovation resource mismatch, using provincial panel data from Chinese pharmaceutical manufacturing industry from 2011 to 2020.FindingsThe enhancement of the digital economy development level can effectively promote China's pharmaceutical manufacturing industry's performance in green innovation.; The pharmaceutical manufacturing industry in China exhibits varying degrees of innovation resource misallocation in 29 provinces and cities, and there exists a threshold effect of innovation resource mismatch within the advancement of the digital economy on the performance of green innovation in the pharmaceutical manufacturing industry, and there is spatial and temporal variability.Originality This study provides valuable insights for integrating digital technology and green innovation elements into the pharmaceutical manufacturing industry. It highlights the importance of rationalizing innovation resource allocation and fostering the industry's green and high-quality development. The empirical evidence presented here also contributes to understanding sustainable development paths for the pharmaceutical manufacturing industry in other countries.

Technology accumulation plays a vital role in research and development (R&D) activities. This paper used technology accumulation as the threshold variable to construct a dynamic panel threshold model to explore the technology accumulation threshold effect of independent R&D on innovation performance of China's pharmaceutical manufacturing industry over the period 1995~2019. The results show that the independent R&D of China's pharmaceutical manufacturing industry had a significant promotion effect on innovation performance. However, it is constrained by the level of technology accumulation, showing a significant double threshold effect of technology accumulation. A moderate level of technology accumulation was more conducive to independent R&D to drive innovation performance, while lower or higher technology accumulation will weaken independent R&D promotion on innovation performance. This study provided insights for policymakers and managers in making effective innovation strategies.