Regulatory & Policy

China targets 25% of global first-in-class drugs by 2030 in new pharma five-year-plan

China targets 25% of global first-in-class drugs by 2030 in new pharma five-year-plan

China has set a target for domestically originated first-in-class (FIC) drugs to account for at least 25% of the global total by 2030, alongside annual growth of more than 20% in its innovative-drug industry and at least five Chinese-origin medicines reaching global annual sales above USD 1 billion, under a new five-year pharmaceutical industry plan issued by ten government ministries.

The 医药工业发展“十五五”规划 (15th Five-Year Plan for Pharmaceutical Industry Development), published on September 18, sets out China's pharmaceutical industrial policy for 2026–2030. Led by the Ministry of Industry and Information Technology (MIIT), the issuing group also includes the National Development and Reform Commission, National Health Commission, National Healthcare Security Administration, National Medical Products Administration, Ministry of Commerce, and other central government bodies.

The targets are described as expected or indicative goals rather than legally binding requirements. By 2030, China aims for revenue at large-scale pharmaceutical industrial enterprises to exceed RMB 3.5 trillion, while listed pharmaceutical companies maintain average annual R&D intensity of at least 10%. The plan also calls for China to rank among the global leaders in both new-drug programs entering first-in-human trials and innovative-drug approvals, alongside the FIC and blockbuster-sales targets. More than 200 innovative medical devices are targeted for approval, while at least 50 pharmaceutical companies are expected to exceed RMB 10 billion in annual revenue and 20 pharmaceutical industry parks to reach RMB 100 billion scale.

The innovation targets build on a rapid expansion of China's drug-development sector during the preceding five-year period, when the country moved toward the front ranks globally in clinical-stage pipeline volume. The new plan places greater emphasis on original innovation and global commercialization rather than simply expanding the number of domestic development programs.

Among the technologies prioritized are drugs against new and traditionally difficult-to-drug targets, cell and gene therapies, radiopharmaceuticals, precision diagnostics, gene editing, advanced drug-delivery technologies, organoids, organ-on-chip systems, and AI-enabled drug discovery. The plan calls for wider use of artificial intelligence across molecular design, virtual screening, candidate assessment, clinical trial operations, manufacturing, quality control, and regulatory review.

For cell and gene therapy and other advanced modalities, the plan places particular emphasis on manufacturing scale-up. It calls for proof-of-concept and pilot-scale production platforms, shared mid-scale manufacturing infrastructure, and closer cooperation between drug developers and suppliers of critical equipment and raw materials. The aim is to reduce the gap between laboratory development and commercial-scale production, an area Beijing increasingly treats as part of pharmaceutical competitiveness and supply-chain security.

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Clinical development and regulation are also targeted. The plan calls for shorter clinical trial startup timelines, stronger research-hospital trial infrastructure, greater use of real-world data in lifecycle evaluation, and further alignment of Chinese regulatory standards with international norms. It also supports development of pediatric formulations, rare disease treatments, blood products, and strategic manufacturing reserves for products considered important to public health and emergency preparedness.

Internationalization is another central theme. The government wants more Chinese-developed drugs to enter multi-regional clinical trials, obtain overseas approvals, and progress from licensing-based globalization toward broader joint development and international commercialization. The plan also supports expansion of China-based CRO and CDMO services for global clients, stronger intellectual property protection, and further investment by multinational pharmaceutical companies across research, clinical development, and manufacturing in China.

The geographic strategy remains centered on large biopharmaceutical clusters in the Beijing-Tianjin-Hebei region, Yangtze River Delta, and Greater Bay Area, alongside emerging hubs in Chengdu-Chongqing and central China. Separately, the plan calls for at least 20 pharmaceutical industry parks to reach annual output or revenue of RMB 100 billion by 2030.

The plan does not itself determine how individual innovation targets will be implemented. Key follow-on signals will include NMPA regulatory guidance, NHSA reimbursement and market-access measures, provincial implementation programs, and policies governing international clinical development and commercialization. Those measures will determine how far the 2030 targets translate into higher-value domestic innovation and globally commercialized Chinese drugs.


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