创新药审批“超高速时代”，如何告别“割青苗式”投资？

Core Insights - The Chinese innovative drug industry has transitioned from imitation to breakthrough innovation over the past decade, marking a significant development phase [1] - By 2025, the approval process for innovative drugs in China is expected to enter a "super-fast era," with approval times nearing those of the FDA, indicating a shift towards becoming a global dual-engine for innovative drug launches [1][2] - The number of license-out transactions by Chinese companies reached a record high in 2024, with 94 deals totaling $51.9 billion, reflecting a growing interest from multinational corporations (MNCs) [2][3] Group 1: Market Dynamics - The Chinese biotech sector saw a 78% increase in the first half of 2025, significantly outperforming global peers, although the overall market capitalization remains only 14%-15% of that of U.S. counterparts [4] - The "DeepSeek moment" in the Chinese biopharmaceutical industry signifies a shift towards achieving high-quality innovation at lower costs, challenging established global players [4] - Despite geopolitical and regulatory risks, interest from overseas MNCs in Chinese innovative drugs remains strong, particularly in the U.S. market [5] Group 2: NewCo Model - The NewCo model has emerged as a mainstream approach for Chinese companies to enter overseas markets, allowing them to retain equity and share future value with investors [6][7] - As of Q1 2025, 13 NewCo transactions have been completed by Chinese pharmaceutical companies, totaling over $10 billion, indicating a robust trend towards this model [6] - The NewCo structure helps mitigate financial pressures and enhances competitiveness in international markets by focusing resources on pipeline development [7] Group 3: Financing Challenges - The Chinese innovative drug sector is facing a financing winter, with a significant decline in IPOs and funding amounts in 2024 compared to previous years [8][9] - The number of financing cases in the healthcare sector decreased by 17% in 2024, although total funding increased by 9%, indicating a shift in investor focus [8] - The average funding amount per project in China has dropped by 71% from its peak in 2020, highlighting the challenges faced by early-stage projects [8] Group 4: Strategic Shifts - The trend of "selling seedlings" reflects a strategic necessity for many Chinese innovative drug companies to quickly recoup funds for ongoing research and development [13][14] - The proportion of preclinical projects in license-out transactions has increased from 28% in 2020 to 61% in 2024, driven by areas like oncology and neuroscience [13] - Companies are urged to build independent innovation systems and avoid over-reliance on licensing, which could lead to a loss of competitive edge in the long term [14][15]