China Targets 25% of Global First-in-Class Drugs in New 2030 Biopharma Plan

On September 18, 2026, China’s Ministry of Industry and Information Technology (MIIT), together with nine other government authorities, released the pharmaceutical industry’s five-year plan for 2026–2030. The plan aims to keep China’s biomedical research, development, and application at the global forefront by 2030 while strengthening the international competitiveness and influence of its pharmaceutical industry.

The plan sets out 25 priority tasks across eight areas, including strengthening original innovation capabilities and accelerating the development of frontier technologies and products.

Key 2030 Targets

• At least 25% of global first-in-class drugs to be developed in China.
• The number of innovative drugs approved in China to rank among the world leaders.
• At least 20% average annual growth for the innovative drug sector.
• Combined revenue of pharmaceutical enterprises above the designated scale threshold (defined as annual main business revenue of RMB 20 million) to reach at least RMB 3.5 trillion by 2030.
• The number of pharmaceutical companies with annual revenue above RMB 10 billion to reach 50.
• At least five Chinese drugs to achieve global annual sales exceeding US$1 billion.

These benchmarks signal a structural shift: China is transitioning from a high-volume manufacturing base and consumption market into a top-tier originator of global novel therapies. For international biopharma companies, this evolution reshapes competition, clinical strategy, licensing, and regulatory planning in the region.

Macro Drivers: Policy, Pipeline, and Tech Integration

According to MIIT officials, rapid population aging and rising demand for full-lifecycle healthcare are placing unprecedented demands on the healthcare system, leading domestic manufacturers to prioritize original discovery over volume manufacturing. Near-term data validates this shift: value-added output from major pharmaceutical firms grew 6.4% year-over-year in H1 2026.

Three metrics highlight the speed of this evolution:

• Domestic Breakthroughs: In H1 2026, China approved 38 innovative drugs, with over 80% (31 assets) developed domestically.
• Global Innovative Drug Pipeline: By the end of 2025, China had 4,751 innovative drugs in development, accounting for approximately one-third of the global pipeline and ranking first worldwide. Record Cross-Border Deals: As of September 2026, the reported total value for overseas licensing deals of Chinese-developed drugs had surpassed US$120 billion, up 36% year-over-year.

Recognizing this momentum, Beijing designated biomedicine as one of six national "emerging pillar industries," alongside integrated circuits, aerospace, the low-altitude economy, new energy storage, and intelligent robotics. Combined output across these six strategic sectors is projected to grow from nearly RMB 6 trillion in 2025 to over RMB 10 trillion by 2030.

To maintain this trajectory, the plan prioritizes AI-driven drug discovery and smart manufacturing. While specific NMPA regulatory frameworks for AI remain under development, the strategic imperative is clear: advanced digital tools are now central to China’s biopharma roadmap.

Strategic Implications for International Biopharma

China’s expanding domestic pipeline is fundamentally altering the global competitive landscape for foreign pharmaceutical and biotechnology firms.

Multinational corporations (MNCs) now face an environment where local Chinese biotechs boast well-funded pipelines, aggressive international commercial goals, and strong state support. However, China remains both a critical market for global drugs and a primary hunting ground for early-stage and clinical-stage asset licensing. 

Navigating this dual reality requires aligning clinical development, regulatory affairs, and market access into a unified strategy.

1. Shift China Strategy Earlier in the R&D Lifecycle

Multinational developers should consider China-specific regulatory and clinical development requirements early in their development strategy, including the planning of clinical trials and potential participation in multiregional clinical trials (MRCTs).

Key considerations include:

• Trial sequencing and multi-regional clinical trial (MRCT) inclusions
• Competitive profiling against fast-moving domestic candidates
• Aligning commercialization goals with local healthcare reimbursement dynamics

2. Align Regulatory Strategy with Innovation Priorities

While the plan does not introduce new drug registration requirements, its emphasis on innovative medicines and advanced technologies reinforces the importance of early regulatory planning. Companies should assess applicable China-specific technical requirements , including data integrity, dossier preparation, CMC requirements, and regulatory authority interactions.

3. Leverage High-Value Cross-Border Partnerships

China’s expanding biotech ecosystem provides opportunities for cross-border collaboration. Strategic partnership models increasingly include:

• In-Licensing & Out-Licensing: Acquiring or granting global or regional rights to innovative drug assets developed in China.
• Co-Development Programs: Sharing early-stage translational research costs and clinical risk.
• Joint R&D & Commercialization: Partnering with established domestic firms to accelerate local clinical execution and hospital market coverage.

As Chinese-developed assets gain greater international reach, these relationships may become an increasingly important component of global pharmaceutical strategy.

Final Thoughts: Navigating China’s Evolving Biopharmaceutical Landscape

The 15th Five-Year Plan sets a distinct trajectory for China's biopharmaceutical sector: higher technological intensity, larger corporate champions, and accelerated global commercialization. 

To remain competitive as these dynamics unfold, global biopharma executives should monitor four critical operational indicators:

• Pipeline Maturity: The rate at which local candidates transition into pivotal Phase III trials and gain global regulatory clearance.
• Outbound Licensing Volume: The velocity at which foreign pharma absorbs Chinese-originated assets into global pipelines.
• Regulatory Evolution: Relevant NMPA regulatory and technical guidance affection innovative medicines, including cell andgene therapies and complex biologics.
• Global Harmonization: Broader adoption of international research standards and cross-border regulatory alignment. 

Succeeding in this evolving ecosystem demands localized regulatory intelligence, proactive dossier preparation, and tight alignment between regulatory strategy and commercial execution. Cisema provides foreign pharmaceutical and biotechnology companies with end-to-end guidance across Asia, from initial regulatory strategy and dossier submissions to local representation and direct health authority engagement across the product lifecycle.

To evaluate your regulatory strategy under the new Five-Year Plan and build a compliance roadmap aligned with China’s biopharmaceutical future, contact Cisema today.

Further Information

Explore Cisema’s services for pharmaceutical consulting in Asia Pacific.

Read Cisema’s coverage of the China’s 15th Five-Year Plan: Implications for Drugs, Medical Devices, & Market Access China’s 15th Five-Year Plan: Implications for Drugs, Medical Devices, & Reimbursement

Reference

China aims to cement its place at forefront of biomedical innovation with new 5-year plan