国泰海通｜医药：国内创新药景气度强复苏，看好内需CRO业绩持续改善

Group 1 - The core viewpoint of the article highlights the recovery of clinical CRO demand due to the rebound in innovative drug financing and R&D activities, regulatory emphasis on efficiency, and the transition to data-driven and intelligent clinical execution models [1] Group 2 - Innovative drug financing and BD (business development) activities have shown a synchronized recovery, with the primary market financing amount in the healthcare sector reaching approximately 79.5 billion yuan from Q1 to Q3 of 2025, representing a year-on-year increase of 22%. This shift indicates a move from "early and small investments" to "clinical and certainty-based investments" [1] - The scale of Chinese innovative drug BD activities abroad reached a historical high, with a total transaction amount of approximately 135.7 billion USD and upfront payments of about 7 billion USD for the year [1] Group 3 - The number of IND (Investigational New Drug) applications has continued to rise, with the CDE (Center for Drug Evaluation) accepting 1,878 INDs in 2025, a year-on-year increase of 13.3%. The proportion of Class 1 innovative drugs has increased to 1,517 varieties, indicating a concentration of R&D resources on high clinical value innovative projects [2] - Approval rates for Class 1 innovative drug INDs are approximately 96.5%, while NDA (New Drug Application) approval rates are around 86.9%, reflecting improved review efficiency and approval rates [2] Group 4 - The global regulatory focus has shifted from "risk avoidance" to "efficiency first," which is expected to accelerate clinical trial timelines. The FDA has prioritized enhancing R&D and review efficiency, including streamlining clinical initiation processes and allowing more dynamic data usage [2] Group 5 - Clinical trials are evolving towards data-driven and continuous processes, with a shift from "phase-based advancement" to "process management and data-driven" approaches. This evolution requires CROs to extend their capabilities beyond mere execution to include data collection, quality control, statistical analysis, and IT system capabilities [3] - The implementation of continuous trial designs, real-time data monitoring, and phase-based submissions is becoming more common, enhancing the efficiency of clinical execution [3] - Leading CROs with digital platforms, compliance systems, and scale advantages are better positioned to translate technological capabilities into execution efficiency, thereby reflecting higher certainty during the recovery phase [3]