2025年我国批准创新药76个 创历史新高

Group 1 - The core viewpoint of the articles highlights that by 2025, China has approved 76 innovative drugs, with a total authorized transaction amount exceeding 130 billion USD, marking historical highs in both transaction value and quantity [1] - Among the 76 approved innovative drugs, there are 47 chemical drugs, 23 biological products, and 6 traditional Chinese medicines, with domestic innovative drugs accounting for 80.85% of chemical drugs and 91.30% of biological products [1] - The approval of 11 first-in-class innovative drugs in 2025 includes 4 that are independently developed in China, indicating a significant advancement in the country's biopharmaceutical sector from following to competing and leading in some areas [1] - China's new drug pipeline represents approximately 30% of the global total, ranking second worldwide, reflecting the increasing investment in R&D by domestic companies [1] Group 2 - The next steps involve directing more review resources towards clinically urgent key varieties, particularly innovative drugs with new mechanisms and targets, and enhancing support for these initiatives [2] - There will be further improvements to the drug trial data protection system and the market exclusivity system, aimed at systematically strengthening the protection of innovation [2]