从数量爆发到价值筛选：中国创新药竞争格局演进

Core Insights - The future of China's innovative pharmaceuticals must shift from "scale narrative" to "value narrative" to address the challenges of market competition and ensure sustainable development [2][33] Group 1: Industry Growth and Challenges - The past decade has been a golden era for China's innovative pharmaceutical industry, transitioning from "catching up" to "explosion" due to policy benefits, talent return, and capital support [2] - The number of innovative drugs approved in China increased from 13 in 2015 to a projected 45 in 2024 and 74 in 2025, marking a historical record [3] - Clinical trials surged from 472 in 2015 to 2,316 in 2025, with biological products showing significant growth, increasing from 96 trials to 1,041, capturing 44.95% of the total by 2025 [5] Group 2: Structural Issues and Market Dynamics - Despite the growth, there is a mismatch between research enthusiasm and disease burden, with oncology trials making up 34% of total trials while accounting for only 18.7% of the disease burden [10] - The concentration of clinical trials in specific targets has led to homogenized competition, resulting in "involution-style price reductions," with average price drops of 59.4% in the first round of negotiations for 281 innovative drugs from 2015 to 2025 [12][20] - The price of PD-1 drugs has significantly decreased over time, with the initial price of 19,800 yuan for a 200mg dose dropping to 570 yuan for newer products, highlighting the impact of competitive pricing on profit margins [21][23] Group 3: Value Assessment and Market Access - The strategic purchasing nature of the national medical insurance fund is becoming more pronounced, with about half of innovative drugs not included in the insurance catalog from 2015 to 2024 [24] - The focus is shifting from merely having drugs to the quality of drugs, with a significant preference for those with robust clinical evidence in negotiations [28] - By 2027, a nationwide unified value assessment system based on real-world research will be established, emphasizing support for true innovation and differentiated products [32] Group 4: Future Directions - The industry must transition to a value narrative, encouraging differentiated research and avoiding overcrowded competitive targets to meet unmet clinical needs [33] - Companies should enhance their global perspective for industrial upgrades, aligning with mature markets' research paradigms and regulatory standards to achieve competitive advantages [33]