China Biopharma's Clinical Turn: Early-Stage, Global, and Leaner Teams

This report benchmarks clinical development efficacy in China's biopharma industry, revealing a shift towards early-stage and non-oncology projects, increasing global integration, and evolving organizational structures. It highlights the pursuit of efficiency through optimized staffing models and strategic talent development, emphasizing the need for adaptable and globally competent professionals. The industry aims for greater global influence, digital transformation, and enhanced local collaboration in the coming years.

Evolving Clinical Development Landscape

• Phase Distribution Shift: While Phase III clinical trials remain dominant, their proportion is declining as both multinational corporations (MNCs) and domestic pharmaceutical companies increase early-stage R&D projects.
• Growth & Focus Areas: Overall clinical trial numbers are growing, with MNCs showing faster growth. There's a notable shift from oncology to non-oncology projects, particularly among MNCs.
• Global Integration: The proportion of multinational implementation in early-stage trials is increasing, signaling a more global strategy for clinical development, especially for domestic firms.

Organizational Structures & Staffing Dynamics

• Dominant Models: 70% of surveyed companies (including 64% MNCs and 83% local innovators) favor a unified local management model (M1) for clinical medical and operations, indicating its perceived efficiency for local operations.
• Staffing Reductions: Overall clinical development (CD) staffing slightly decreased in 2024 compared to 2023, driven by financing challenges, project adjustments, and efficiency demands, with local innovative companies showing significant reductions.
• MNC Staffing Trends: MNCs, especially those adopting the M1 model, maintained or slightly increased their staffing, reflecting a recognized efficiency and continued investment in clinical development within this structure.

Efficiency Benchmarking & Outsourcing Strategies

• Efficiency Discrepancies: MNCs generally demonstrate higher clinical development efficiency than local innovative companies, though both improved in 2024. The M1 organizational model consistently outperforms M2 in efficiency metrics.
• Outsourcing Approaches: Local innovative firms primarily build their own clinical teams (less than 20% outsourcing), whereas MNCs employ diverse outsourcing models, with 78% outsourcing over 50% of projects, and 21.4% fully outsourcing.
• Optimal Outsourcing: Companies with 51-80% outsourcing ratios show optimal efficiency, particularly in Project Manager (PM) per capita projects, and Clinical Research Associate (CRA) per capita enrollment has increased across the board.

Talent Trends & Strategic Adaptation

• Talent Flow: Talent movement is cautious, with a trend of talent from smaller biotechs returning to larger foreign pharmaceutical companies and established local pharmaceutical firms.
• Skill Demands: There's high demand for professionals with successful IND (Investigational New Drug) and NDA (New Drug Application) experience, especially in overseas markets, and a growing need for "compound skills" that integrate R&D, medical, and commercial expertise.
• Talent Strategies: Companies are focusing on adapting talent strategies to address global capability gaps, build versatile teams, and leverage precise matching systems and continuous training for long-term talent retention and development.

Future Vision & Strategic Imperatives for China's R&D

• Global Integration Goals: R&D leaders anticipate China's full integration into global Phase III clinical trials and early-stage global development for unmet medical needs, aiming for simultaneous global regulatory submissions.
• Technological Advancement: A key focus is accelerating digital transformation, including the application of AI in clinical trials and the development of integrated digital clinical platforms.
• Strategic Collaborations: Strengthening joint innovation mechanisms with local biotechs and fostering deeper collaboration with CROs and academia are critical for driving original innovation and global project involvement.
• Talent as Core Asset: Talent is viewed as the most crucial competitive barrier, with an emphasis on attracting, incentivizing, and retaining top professionals, and continuously enhancing local talent competency to meet global standards.