China: A Healthcare (PRC Firms) Overview

Continuing to Improve Foreign Investment Opening-Up Policies

The Chinese government continues to deepen its strategy of opening up, consistently introducing favourable policies aimed at optimising the foreign investment business environment. Key emphasis has been placed on developing and launching new opening-up measures, particularly in sectors such as healthcare.

In line with this, relevant regulatory authorities have rolled out concrete initiatives to facilitate the orderly opening-up of the healthcare sector.

• In the foreign investment area, China has rolled out proposals such as supporting eligible foreign-invested enterprises in participating in pilot programmes for the segmented production of biological products, optimising the market approval processes for innovative drugs and the volume-based procurement (VBP) mechanism, and encouraging foreign-invested enterprises to engage in China’s new industrialisation drive.

• Regarding market access, the negative list has been further relaxed, with restrictions on foreign-invested enterprises engaging in internet information services for pharmaceuticals and medical devices being progressively lifted. This significantly lowers the institutional barriers for foreign-invested enterprises seeking to enter the Chinese market.

The localising manufacturing strategy of imported products continues to deepen, with the pathways for converting imported medical devices to domestic production being further clarified and optimised. This not only accelerates the market access and supply of advanced medical products, but also fosters the integration of China’s high-end manufacturing capabilities with global industrial chains.

Advancing Full-Chain Support for Pharmaceutical Innovation

China’s policy framework for innovative drugs and medical devices is undergoing further profound development, progressively perfecting a full-chain support system that spans research and development (R&D), regulatory review, payment and industrialisation.

Efforts include optimising VBP policies for drugs and medical consumables, enhancing the drug pricing mechanism and establishing a dedicated catalogue for innovative drugs.

While the Medical Devices Administration Law is still under legislative review, China has proactively introduced multiple initiatives to intensify support for R&D innovation and optimise full life-cycle regulation to foster the innovative development of high-end medical devices. During the R&D and approval stages, regulatory authorities have strengthened guidance for innovative medical devices throughout the R&D process, channelling more regulatory review and approval resources towards clinically urgent and key innovative medical devices.

To meet the distinct characteristics of biomedical technologies – including their rapid pace of iteration, highly personalised nature, significant innovative potential, complex R&D challenges and manifold associated risks – relevant regulations governing the clinical research and translational applications have been promulgated to regulate the application of biomedical technologies.

To continuously encourage R&D innovation, regulatory authorities are dedicated to improving the intellectual property protection mechanisms. This includes, for instance, refining the rules for the protection of pharmaceutical test data, thereby providing more robust legal safeguards for innovative achievements.

Regarding market access and payment, China made its first attempt to introduce the first commercial health insurance catalogue for innovative drugs. This represents a significant step in bridging basic medical insurance with commercial health insurance, aiming to establish a multi-tiered medical security system. This catalogue is designed to provide diversified payment coverage for innovative drugs that have high clinical value but are not yet covered by the basic medical insurance catalogue, thereby enhancing drug accessibility.

Meanwhile, the capital market has enhanced institutional inclusiveness, offering greater financing opportunities for high-quality but unprofitable innovative enterprises, particularly those engaged in innovative drug R&D.

Deepening Fair Competition and Market Integrity Through Enhanced Compliance

China’s compliance regulatory framework for the pharmaceutical sector has been significantly strengthened. The State Administration for Market Regulation issued the first national industry-specific guideline on anti-commercial bribery within the healthcare sector. Concurrently, the newly amended Anti-Unfair Competition Law has further clarified the legal liabilities of business operators and associated individuals involved in commercial bribery as the bribe-offering party, while also imposing heavier penalties for violations such as commercial bribery and false advertising.

Meanwhile, the credit evaluation system for pharmaceutical pricing and procurement has been further refined, with more stringent evaluation criteria and greater accountability for both manufacturers and Marketing Authorisation Holders (MAHs). Moreover, the issuance of antitrust compliance guidelines for the pharmaceutical sector has further clarified market competition rules. While delineating regulatory “red lines”, the guidelines emphasise the need for companies to proactively establish effective internal compliance systems rather than merely reacting to enforcement. This approach fosters a fairer market competition environment and promotes the healthy and orderly development of the industry.

Regulatory rules in advertising and personal information protection have also evolved to better align with practical needs. Regulatory authorities have issued a series of guidelines clarifying the boundaries between commercial advertising, medical education and public information dissemination, while also refining criteria for identifying unfair competition behaviours like false advertising and establishing stringent qualification requirements and behavioural norms for medical popular science content disseminated via self-media platforms.

In addition, the introduction of a personal information protection compliance audit mechanism has raised the level of lawful data processing, while inter-agency enforcement actions are specifically targeting illegal activities related to the infringement of personal information, such as in sensitive sectors like healthcare, thereby contributing to the establishment of a standardised protective framework.

Further Optimising the Medical Security System

Over the past year, China’s healthcare security system has undergone continuous optimisation, aimed at:

• establishing a multi-tiered system that is sustainable;
• providing all-citizens’ coverage;
• co-ordinating urban and rural areas;
• featuring clearly defined rights and responsibilities; and
• offering an appropriate level of benefits.

Key initiatives include the systematic advancement of a drug traceability system, the enhancement of supply chain security and safety for medical products, and the launch of pilot programmes for comprehensive value assessment of real-world medical insurance data. These efforts are designed to establish a more scientific, efficient and well‑governed medical insurance system that ensures the long‑term safety and sustainability of insurance funds.

Specifically, the drug traceability code system has seen a phased rollout since July 2025, covering the vast majority of medical institutions and retail pharmacies. This system leverages big data-driven regulatory models to combat illicit activities such as fraudulent substitution of reimbursable drugs and illegal resale. Concurrently, pilot programmes for comprehensive value assessment of real-world medical insurance data have been progressively launched, marking a new phase for the medical insurance governance system as it pivots towards a comprehensive value assessment framework centred on real-world evidence. These initiatives, coupled with the draft Medical Security Law collecting public comments, underscore the government’s commitment to further refining the medical security system.

Sustaining the Strong Momentum of Innovative Products Expanding Globally

China’s innovative pharmaceutical products continue to show strong momentum in global expansion. Since 2015, the biopharmaceutical industry has emerged as one of the most dynamic sectors in capital markets. Licence-out transactions have become a critical source of capital and a key pathway to internationalisation for innovative drug companies. Amid the resurgence of the Hong Kong stock market and recovering global investor confidence, companies are actively exploring diversified co-operation models, including Hub-and-Spoke and Real-World Asset (RWA) frameworks, to establish a more effective global footprint.

On the policy front, national and local governments have intensively rolled out a suite of comprehensive, end-to-end supportive policies covering the entire lifecycle of innovative drugs, from R&D to reimbursement. These measures are continuously optimising the development ecosystem for novel therapies, laying a solid foundation for Chinese pharmaceutical companies to expand overseas and elevate China’s position in the global value chain.

持续完善外资开放政策

中国政府持续深化对外开放，不断发布优化外资营商环境的利好政策，进一步强调尤其要在医疗等领域研究推出一批新的开放举措。

相关监管部门相应出台了具体方案推动医药领域的有序放开，具体地：

• 在稳外资方面，提出支持符合条件的外资企业参与生物制品分段生产试点、优化创新药上市流程和药品带量采购机制、鼓励外资企业参与我国新型工业化进程等。
• 在市场准入方面，进一步放开负面清单，从事药品和医疗器械互联网信息服务领域的限制逐步解除，显著降低了外资企业进入中国市场的制度性门槛。

“地产化”战略继续深化，进口医疗器械转为境内生产的路径得到进一步明晰和优化。不仅加速了先进医疗产品的市场准入和供应，也促进了国内高端制造能力与全球产业链的融合。

全链条支持创新医药的纵深推进

中国创新药与创新医疗器械领域的政策体系进一步纵深推进，逐步完善覆盖研发、审评、支付与产业化等环节的全链条支持体系。

优化药品和耗材集采政策、健全药品价格形成体系并制定创新药目录。

尽管《医疗器械管理法》仍在制订中，但国家亦积极部署多项举措，加大对医疗器械研发创新支持力度、优化全生命周期监管支持高端医疗器械创新发展。在研发和审批环节，监管机构加强对创新医疗器械研发的全程指导服务，将审评审批资源更多向临床急需的重点创新医疗器械倾斜。

为契合生物医学技术迭代快、个性化属性强、创新程度高、研发难度大、风险多等特点，相关临床研究和临床转化应用管理规定出台以规范生物医学新技术的研发应用。

为持续鼓励研发创新，监管机构着力完善知识产权保护体系，例如通过细化药品试验数据的保护规则，为创新成果提供更强有力的法律保障。

在市场准入和支付环节，首次尝试推出商业健康保险创新药品目录。这是基本医疗保险与商业健康保险衔接的重要探索，旨在构建多层次医疗保障体系，为高临床价值但暂时无法纳入基本医保的创新药品提供多元化支付保障，提升药品可及性。

此外，资本市场增强制度包容性，为创新药研发企业等优质未盈利创新企业，提供了更为有力的融资支持机会。

强化合规促进公平竞争与市场廉洁

中国医药行业合规监管体系进一步完善。市场监管总局发布了全国首个行业内的医药反商业贿赂指引，新修订的反不正当竞争法进一步明晰了商业贿赂中行贿方经营者及相关自然人的法律责任，并且加大了对商业贿赂、虚假宣传等违法行为的处罚力度。同时，医药价格和招采信用评价制度进一步完善，评价标准趋严，并强化了对生产企业和上市许可持有人的责任穿透。此外，药品领域的反垄断监管指导原则也已出台，进一步明确市场竞争规则。各项监管举措共同构成了更为清晰的企业合规框架，在划定监管”红线”的同时，强调企业需主动建立有效的内部合规体系，而非被动应对，营造了更加公平的市场竞争环境，促进行业健康有序发展。

广告与个人信息保护领域的监管规则日趋贴合实操需求。监管部门发布系列指南，明确界定商业广告与医疗科普、信息公示的边界，细化虚假宣传等不正当竞争行为的认定标准，并对自媒体医疗科普设置严格的资质要求和行为规范。个人信息保护合规审计机制的引入提升了信息处理活动的合法合规水平；跨部门联合执法行动重点关注医疗等敏感领域的个人信息违法活动，有利于构建规范化保护屏障。

进一步优化医疗保障制度

医疗保障制度在过往一年持续优化，致力于构建覆盖全民、城乡统筹、权责清晰、保障适度、可持续的多层次医疗保障体系，举措包括有序推进药品追溯体系建设，提高医药产品供应和安全保障能力，以及开展真实世界医保综合价值评价试点工作等，旨在构建更加科学高效的医保管理体系，确保医保基金安全可持续运行。

具体而言，药品追溯码制度自7月起逐步实施，覆盖绝大多数医药机构和零售药店，并将通过大数据监管模型打击串换药品、倒卖药品等违法违规行为。同时，真实世界医保综合价值评价试点工作逐步开展，医保治理体系迈向以真实世界证据为核心的综合价值评价新阶段。该等举措，连同正在公开征求意见的医疗保障法草案，共同体现了政府对进一步优化医疗保障制度的决心和努力。

创新产品出海态势持续向好

中国创新医药产品出海态势持续向好，2025年以来生物医药行业成为资本市场最具活力的板块之一。Licence-out交易成为创新药企重要的资金来源与国际化路径。伴随港股市场复苏与全球投资信心回升，企业正积极探索包括Hub-and-Spoke（中心辐射型）与RWA（真实世界资产）在内的多元化合作模式，以实现更高效的国际市场布局。在政策层面，国家及地方密集推出覆盖创新药研发到支付等环节的全链条支持性政策，持续优化创新药全生命周期发展环境，为中国创新药企拓展海外市场、提升中国在全球价值链中的地位提供了坚实基础。