创新药 大消息！

Core Insights - The new round of the "National Major Science and Technology Project for Innovative Drug Development" has officially launched, aiming for leapfrog development by 2025 [1] - The previous project from 2008 to 2020 achieved significant results, transitioning China's drug development from imitation to innovation [1] Industry Challenges - China's biopharmaceutical industry faces challenges, particularly in original innovation capabilities, with First-in-Class (FIC) drugs being significantly fewer compared to developed countries [2] - As of August 2025, the top 20 Chinese companies have only one-third of the FIC pipeline compared to the top 20 global pharmaceutical companies [2] - International clinical research participation is low, with only 2.6% of clinical studies conducted by Chinese companies being international multi-center studies, compared to 24.9% for foreign companies [2] Project Management Innovations - The new project introduces a "two total, two offices" management structure to enhance professional management and collaborative efficiency [3] - The project organization model shifts from universities and research institutions to innovative R&D enterprises, forming large interdisciplinary teams to address previous fragmentation [3] - There is a focus on strengthening collaboration with national-level technology plans and enhancing the regulatory science system to improve the review capabilities for innovative drugs [3] Future Goals and Focus Areas - The project aims to achieve four transformations by 2035, including a shift from variety-focused R&D to building new drug creation capabilities [3] - Emphasis will be placed on upstream innovation chains and supporting original drug development rather than just generic drugs [3] - The guidelines for 2025 and 2026 will focus on new targets, technologies, and theories, including AI-driven drug discovery and new mechanisms for pain management [4] - By 2035, the goal is to establish a robust national drug innovation system, breakthrough key technologies, and create high-level innovative drugs tailored to China's disease spectrum [4]