Core Insights - The Chinese stem cell therapy industry is accelerating towards a "clinical verification" era, but many leading research teams face significant challenges in the IND (Investigational New Drug) application process, often leading to delays and missed opportunities [1][2][3] Group 1: Challenges in IND Application - The unique characteristics of stem cell drugs, such as live cell properties and production process complexity, impose higher regulatory requirements for safety and quality control compared to traditional drugs [2][3] - Over 60% of stem cell IND applications submitted in the past three years have required supplementary information, with some projects being halted due to ineffective responses to review comments [1][2] - Key challenges include difficulties in converting experimental data into compliant documentation, frequent process optimizations leading to quality consistency concerns, and insufficient identification of critical quality attributes (CQA) [3][4] Group 2: Importance of Registration Strategy - There is a disconnect between research and registration functions, with many teams only starting registration preparations late in the development process, which should be integrated throughout [4][8] - Successful projects often involve early engagement of regulatory experienced teams to establish quality systems and registration narratives, significantly reducing compliance risks [4][8] Group 3: Emergence of CQDMO Model - A new service model, Contract Quality & Development and Manufacturing Organization (CQDMO), is emerging, emphasizing registration-driven strategies and regulatory understanding alongside traditional production services [5][6] - Companies like Jiuzhitang Meike have successfully implemented the CQDMO model, supporting multiple stem cell projects through efficient IND application processes [6][7] Group 4: Market Potential and Future Outlook - The global stem cell market is projected to exceed $100 billion by 2030, with China's market expected to surpass 200 billion RMB, indicating a shift from technology followers to independent innovators [10][11] - The ability to navigate the IND application process effectively will become a critical competitive advantage for companies in the stem cell sector, as they seek to translate research breakthroughs into clinical applications [11][12]