创新药，大消息！

Core Viewpoint - The new round of the "National Major Science and Technology Project for Innovative Drug Development" has officially launched, aiming for leapfrog development in China's pharmaceutical industry by 2025 [1][2]. Summary by Sections Background and Achievements - From 2008 to 2020, the "Major New Drug Creation" project achieved significant results, transitioning China's drug development from imitation to innovation and enhancing the pharmaceutical industry from large-scale to strong [1]. Current Challenges - The Chinese biopharmaceutical industry faces challenges, including weak original innovation capabilities, with the number of First-in-Class (FIC) drugs in China's top 20 companies being only one-third of that in the global top 20 [2]. - There is a lack of core technologies driving new drug development, and the discovery of new targets and treatment strategies lags behind developed countries [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]. Innovations in Project Management - The new project introduces a "two generals and 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 teams across institutions and disciplines to address fragmentation issues [3]. - There is a focus on strengthening collaboration with national-level scientific plans and enhancing the regulatory science system to improve the review capabilities for innovative drugs [3]. Future Goals and Directions - The project aims for four transformations by 2035: from focusing on variety development to building new drug creation capabilities; from emphasizing downstream industrial chains to focusing on upstream innovation chains; from supporting generic drugs to prioritizing original drug development; and from targeting 10 major diseases to addressing diseases based on China's disease spectrum and market failures [3][4]. - The guidelines for 2025 and 2026 will focus on new targets, technologies, and theories, including AI-driven original target discovery and new paradigms for traditional Chinese medicine [3][4]. Expected Outcomes - By 2035, the goal is to establish a self-controlled, efficient national drug innovation system, breakthrough key technologies in various drug categories, and create high-level innovative drugs with clinical value tailored to China's disease spectrum [4]. - The aim is to cultivate leading international enterprises with strong innovation capabilities and to position China as a global center for new drug creation and biopharmaceutical industry [4].