China Policies for Cancer Research, Healthcare and Prevention

Chijie Wang^1,3, Wei Jiang^2,3, Su Li¹, Jun Ma^2,*

¹Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
²Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P. R. China
³These authors contributed equally to this work *Correspondence: majun2@mail.sysu.edu.cn

Cancer has become one of the leading threats to population health in China, with its incidence continuing to rise and marked disparities across regions and population groups. This growing burden poses a significant public health challenge. According to data released in 2024, over 4.8 million new cancer cases and approximately 2.5 million cancer-related deaths occurred in China in 2022¹. The five most commonly diagnosed cancers were lung, colorectal, thyroid, liver, and stomach cancers, together accounting for 57.42% of all new cases. Meanwhile, the top five causes of cancer-related death – lung, liver, gastric, colorectal, and esophageal cancers – constituted 69.25% of total cancer deaths nationwide. The total annual cost of cancer treatment in China was estimated at 221.4 billion RMB, representing 5.4% of the country’s total health expenditure. In addition, productivity losses due to premature cancer-related mortality were estimated to reach 28 billion USD annually [2]. In response to these challenges, China has introduced a series of policy initiatives across early screening, drug development, and personalized treatment, guided by a translational research framework. These efforts aim to promote innovation while addressing disparities in the allocation of cancer prevention and treatment resources.

Early Screening in China: Expanding Coverage and Standardizing Practice

Since 2005, China has progressively implemented cancer screening and early diagnosis programs across rural areas, the Huai River Basin, and urban regions in an effort to reduce the disease burden associated with malignant tumors [3]. High-incidence cancers such as lung, gastric, esophageal, colorectal, breast, and cervical cancers have been included in national screening initiatives [4]. Taking upper gastrointestinal cancers as an example, as of 2018, 194 program sites had been established nationwide, screening a total of 2,166,245 individuals and identifying 34,607 cancer cases, with a detection rate of 2.05%. The early diagnosis rate in this group exceeded 70% [5]. Similarly, the early diagnosis rate for liver cancer improved markedly, rising from 66.06% in 2008 to 96.79% in 2022 [6].

In 2009, breast and cervical cancer screening programs were incorporated into China’s National Major Public Health Service Projects, providing free screening services to eligible rural women in targeted regions. Between 2009 and 2020, approximately 140 million cervical cancer screenings and over 65 million breast cancer screenings were conducted. As of 2020, cervical cancer screening programs had been implemented in 2,644 counties (cities/districts), covering 87% of all administrative regions nationwide, while breast cancer screening programs had reached 2,456 counties (cities/districts), representing 81% coverage [7].

China has consistently emphasized the importance of early detection and treatment through ongoing policy efforts to expand screening coverage [8.9]. To ensure standardized screening quality nationwide, the National Cancer Center of China has developed and published evidence-based guidelines for the early diagnosis and treatment of multiple cancer types (Table 1). In parallel, the government has supported the establishment of “Cancer Screening and Early Diagnosis and Treatment Centers” at the county hospital level and provided professional training opportunities for healthcare workers at all tiers of the healthcare system.

 

Table 1. Published National Guidelines for Cancer Screening, Early Detection, and Early Treatment in China [7]

Cancer type	Year	Guideline
Colorectal Cancer	2020	Chinese Guidelines for Colorectal Cancer Screening and Early Detection and Treatment
Lung Cancer	2021	Chinese Guidelines for Lung Cancer Screening and Early Detection and Treatment
Breast Cancer	2021	Chinese Guidelines for Breast Cancer Screening and Early Detection and Treatment
Esophageal Cancer	2022	Chinese Guidelines for Esophageal Cancer Screening and Early Detection and Treatment
Prostate Cancer	2022	Chinese Guidelines for Prostate Cancer Screening and Early Detection and Treatment
Gastric Cancer	2022	Chinese Guidelines for Gastric Cancer Screening and Early Detection and Treatment
Liver cancer	2022	Chinese Guidelines for Liver Cancer Screening and Early Detection and Treatment

 

Drug Development: A Regulatory Framework for Streamlined Innovation and Accelerated Approval

Accelerated Review and Approval Mechanisms

Since 2015, the enhancement of China’s anti-cancer drug research and development (R&D) system, along with its growing capacity has driven significant progress in new drug innovation. Between 2015 and 2024, a total of 393 anti-cancer drugs were approved globally, of which China approved 158, including 72 domestically developed originator drugs [10]. In recent years, the National Medical Products Administration (NMPA) has introduced a series of policies to regulate and streamline oncology drug development, accelerating the progress of homegrown therapies (Table 2).

To improve review efficiency while maintaining scientific rigor, China has established a multi-tiered accelerated approval framework. For example, since 2020, drugs targeting serious diseases have been allowed to apply for approval based on Phase I/II clinical data [11]. That same year, the conditional approval mechanism was introduced, allowing earlier market entry for drugs treating serious conditions based on surrogate endpoints – such as objective response rate – with the requirement that the marketing authorization holder complete confirmatory Phase III trials within a specified timeframe. Failure to verify clinical benefit may result in revocation of the drug’s registration certificate. This mechanism has significantly shortened the time to market for oncology drugs such as PD-1 inhibitors [12]. Further reforms in 2025 will reduce the regulatory review timeline for clinical trial applications from 60 days to 30 days [13]. Priority will be given to drugs included in national key R&D programs, pediatric oncology and rare disease drugs, and therapies undergoing simultaneous global development. This nationwide reform aims to shorten clinical trial initiation times and is expected to be rolled out across China in the near future.

 

Table 2. Policy Documents Issued in China Since 2015 Regulating Oncology Drug Development

Year	Policy Document
2020	Technical Guidelines for Communication and Exchange on Clinical Aspects of Single-Arm Trial-Supported Oncology Drugs Prior to Entering Pivotal Trials
2020	Technical Guidelines for Clinical Trials of Combination Therapy with Oncology Drugs
2021	Technical Guidelines for Expansion Cohort Studies in First-in-Human Trials of Oncology Drugs (Trial Implementation)
2021	Guiding Principles for Clinical Development of Oncology Drugs Oriented by Clinical Value
2023	Technical Guidelines on the Applicability of Single-Arm Clinical Trial Designs to Support Marketing Applications for Oncology Drugs
2025	Pediatric Oncology Drug Development Incentive Pilot Program (Starlight Program)

 

Regulating the Use of Single-Arm Trials for Conditional Approval

An increasing number of pharmaceutical companies are seeking to use single-arm trials (SATs) to support marketing applications for oncology drugs. However, the absence of randomized parallel controls introduces potential biases that undermine the reliability of benefit-risk assessments based on such trials. These uncertainties include differences in patient populations, variations in assessment methods or evaluators, and the uncertain correlation between surrogate endpoints and survival benefits.

To regulate and standardize the use of SATs in oncology drug development, China issued new guidance in 2023, restricting their application to refractory diseases. The guidance also stipulates that efficacy endpoints must include survival-related measures, such as duration of response, and requires assessment by an independent review committee to minimize bias. In addition, confirmatory studies are required to be initiated early to further validate long-term clinical benefit [14].

Regulating Combination Therapies

Due to the complex nature of tumors, combining agents with distinct mechanisms or targets remains a key strategy for improving treatment efficacy and overcoming therapeutic resistance. While rational combinations can provide better options for patients, poorly designed regimens may increase patient risk, reduce clinical development efficiency, and lead to unnecessary expenditure of time, funding, and healthcare resources.

To improve the quality and scientific basis of combination therapy development, China issued regulatory requirements in 2020 stipulating that combinations must be supported by non-clinical mechanistic evidence (e.g., synergy between immunotherapy and chemotherapy) and employ factorial trial designs to verify the contribution of each individual component. The overall clinical rationale and benefit of the combination must be confirmed through well-designed confirmatory studies [15].

Value-Oriented Principles in Oncology Drug Development

In 2021, China introduced a value-oriented framework for oncology drug development, emphasizing that clinical research should focus on areas of unmet medical need. Developers are encouraged to advance precision-targeted therapies and strategies to overcome drug resistance, as well as to optimize formulations to reduce adverse drug reactions. Early in the development process, patient-centered approaches – such as structured interviews and privacy-protected questionnaires – are recommended to directly gather patient feedback on efficacy, safety, and convenience, thereby informing research direction and design [16].

In parallel, regulatory authorities promote the use of adaptive trial designs, the inclusion of real-world populations, and increased attention to patient-reported outcomes, aiming to ensure that clinical development is not only scientifically rigorous but also aligned with patients’ lived experiences and priorities.

Personalized Treatment: Leveraging Technological Innovation and Advancing Multidisciplinary Care

Since 2017, China has actively promoted the integration of emerging technologies – such as genetic testing – into cancer prevention and treatment efforts to advance personalized care [8]. In non-small cell lung cancer, for instance, the EGFR mutation testing rate has reached 49.6%, and patients receiving targeted therapies have achieved a median progression-free survival of 8.3 months [17]. In parallel, regions such as Beijing and Fujian have begun incorporating genetic testing into public health insurance schemes, lowering out-of-pocket costs for patients to as little as 8-10% [18,19].

In the same period, China has taken active steps to promote a tiered diagnosis and treatment system for chronic diseases, including cancer, to support more efficient use of healthcare resources [8]. Policy directives issued in 2021 highlighted the importance of optimizing cancer care by aligning treatment strategies with tumor-specific pathological characteristics and selecting appropriate modalities such as surgery, chemotherapy, radiotherapy, and targeted therapies. The goal is to formulate detailed, actionable clinical protocols and care pathways to ensure standardized and multidisciplinary treatment delivery [20]. Currently, approximately 82% of hospitals in China implement bidirectional referral mechanisms for cancer patients. The systematic referral rate in specialized oncology hospitals stands at 85.4%, surpassing that of non-oncology hospitals [21].

Conclusion

China has made notable progress in cancer prevention and control through translational research and supportive policy measures, particularly in the areas of early screening, drug development, and personalized treatment. Nevertheless, several challenges remain, including long timelines for translating basic research into clinical application, limited service capacity at the primary care level, and regional disparities in development.

Moving forward, it will be important to strengthen policy support for translational research, improve collaboration among academia, industry, healthcare, and regulatory sectors, increase investment in primary care resources, and advance the development of telemedicine. These efforts will be essential to building a comprehensive, life-course-oriented cancer control system and contributing to the realization of the “Healthy China 2030” initiative.

References

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11.        National Medical Products Administration (NMPA). (2020). Procedures for the Review and Approval of Breakthrough Therapy Drugs (Trial).

12.        National Medical Products Administration (NMPA). (2020). Working Procedures for the Review and Approval of Marketing Applications for Conditionally Approved Drugs (Trial).

13.        National Medical Products Administration (NMPA). (2025). Notice on Matters Related to the Optimization of Clinical Trial Review and Approval for Innovative Drugs (Draft for Public Comment).

14.        National Medical Products Administration (NMPA). (2023). Technical Guidelines on the Applicability of Single-Arm Clinical Trial Designs to Support Marketing Applications for Oncology Drugs.

15.        National Medical Products Administration (NMPA). (2020). Technical Guidelines for Clinical Trials of Combination Therapy with Oncology Drugs.

16.        National Medical Products Administration (NMPA). (2021). Guiding Principles for Clinical Development of Oncology Drugs Oriented by Clinical Value.

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19.        Healthcare Security Administration of Fujian Province. (2022). Notice on Issues Related to the Optimization of Pricing for DNA Sequencing and Other Medical Items.

20.        National Health Commission of the People’s Republic of China. (2021). Action Plan for Improving the Quality of Cancer Diagnosis and Treatment.

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