CRO 业绩持续改善:国内创新药景气度强复苏,看好内需
GUOTAI HAITONG SECURITIES·2026-02-06 03:23

Investment Rating - The report assigns an "Overweight" rating to the industry, indicating a positive outlook compared to the market benchmark [3][37]. Core Insights - The recovery in innovative drug financing and business development (BD) is signaling the industry's entry into a repair cycle, with clinical Contract Research Organization (CRO) demand supported by improved funding conditions [3][6]. - The number of Investigational New Drug (IND) applications has increased, reflecting a substantial recovery in research and development activities, with a notable rise in the approval rates for innovative drugs [3][22][26]. - The global regulatory focus has shifted from risk aversion to efficiency, which is expected to accelerate clinical trial processes and enhance the demand for CRO services [3][29]. Summary by Sections 1. Recovery in Innovative Drug Financing and BD - The primary market financing amount has rebounded, with a total of approximately 79.53 billion RMB raised in the first three quarters of 2025, marking a 22.4% year-on-year increase [6][9]. - The financing structure has improved, with a shift from early-stage investments to later-stage clinical projects, indicating a more substantial commitment to projects with clear clinical pathways [9][10]. - China has become a significant source of projects for multinational corporations (MNCs), with the total amount of transactions involving Chinese assets reaching 39.4 billion USD, accounting for about 37.4% of global transaction amounts [16][18]. 2. Dual Recovery in Applications and Reviews - The number of IND applications has shown a significant increase, with 1,878 applications in 2025, reflecting a 13.34% year-on-year growth [22][23]. - The approval rates for INDs and New Drug Applications (NDAs) have improved, with a 96.53% approval rate for INDs and an 86.87% rate for NDAs, indicating a more efficient review process [26][28]. 3. Intensified Global Competition and AI-Driven Changes - The FDA is promoting continuous trials and the application of AI in clinical execution, which is expected to enhance efficiency in clinical trials [29][30]. - Leading CROs are leveraging AI to transform their delivery models, moving from project-based human delivery to platform-based digital delivery, thereby improving operational efficiency and client retention [30].