普华永道徐佳：中国创新药迎分水岭，量质转型呈分化格局

Core Insights - China's contribution to global innovative drug development has significantly increased, with the number of innovative drugs in development now accounting for approximately 30% of the global total, up from 4.1% a decade ago [1] - The Chinese pharmaceutical industry has become the second largest globally, with several Chinese companies now among the top 25 pharmaceutical firms worldwide [1] - The industry is experiencing a "quantity and quality transformation," characterized by a divide between leading companies and smaller biotech firms, with business development (BD) transactions becoming a crucial cash flow source [1][2] Industry Growth and Trends - The scale of China's innovative drug research pipeline now represents about one-quarter of the global total, with approximately 3,000 clinical trials conducted annually, placing China among the top in the world [3] - The total amount of outbound licensing for domestic innovative drugs has surpassed $100 billion, doubling compared to 2024, indicating a significant increase in global recognition of Chinese pharmaceutical assets [3] - Major deals, such as the collaboration between Sangamo Therapeutics and Pfizer, have set new records for upfront payments, highlighting the growing value of Chinese biotech in the global market [4] Business Development Models - Various business development models are emerging as Chinese companies expand internationally, including the NewCo model and the Co-Co model, which allow for more flexible asset operations and shared development costs [6][7] - Early-stage biotech firms tend to prefer traditional models with upfront payments and milestone payments to secure cash flow, while more established companies are moving towards collaborative development models [7] Ecosystem and Policy Support - A complete ecosystem is essential for the sustainable development of China's innovative drugs, requiring collaboration across research, clinical transformation, regulatory upgrades, and payment innovations [8] - Recent policy changes, including the establishment of a commercial insurance directory for innovative drugs, aim to enhance payment mechanisms and support for high-value drugs [9][10] - The dual-directory approach in payment systems is expected to create new commercial opportunities, accelerating the approval process for new drugs and increasing sales for specialized treatments [9][10] Future Directions - The next growth areas for outbound licensing are anticipated to focus on ADC/dual antibody combination therapies, GLP-1 related targets in metabolic diseases, and localized processes for cell and gene therapies [5] - The industry is expected to see a diversification of business development models, with the Co-Co model becoming more prevalent among leading companies while still coexisting with traditional licensing models [6][7]