国家药监局优化临床急需境外已上市药品审评审批 创新药高景气度延续（附概念股）

Core Viewpoint - The National Medical Products Administration (NMPA) is optimizing the review and approval process for urgently needed foreign drugs already on the market to meet the pressing clinical needs of patients in China [1][2]. Group 1: Regulatory Changes - The NMPA will enhance the review mechanism and accelerate the review speed while improving the inspection system to reflect the characteristics of various drug types [2]. - The NMPA encourages applicants to conduct global synchronous research and simultaneous application for market approval in China for urgently needed foreign drugs [1]. Group 2: Market Performance - In 2025, China approved a record 76 innovative drugs, significantly surpassing the 48 approved in 2024 [2]. - The total amount of authorized transactions for innovative drugs in 2025 exceeded $130 billion, with over 150 transactions, marking another historical high [2]. Group 3: Drug Composition - The 76 innovative drugs approved in 2025 include 47 chemical drugs, 23 biological products, and 6 traditional Chinese medicines [2]. - Among the 47 chemical drugs, 38 are domestic innovations, and 9 are imported, with domestic innovations accounting for 80.85% [2]. - For the 23 biological products, 21 are domestic innovations, and 2 are imported, with domestic innovations making up 91.30% [2]. Group 4: Industry Outlook - The release of the first version of the "Commercial Health Insurance Innovative Drug Directory" in December 2025 establishes a multi-layered payment system, creating new market pathways for high-value innovative drugs [2]. - Industry insiders are optimistic about 2026, anticipating a surge in innovative drug business development (BD) due to supportive industrial policies for true and high-level innovations [2]. - The dual push from commercial insurance implementation and procurement optimization is expected to sustain high prosperity in the innovative drug industry, with high-value innovative drugs likely to experience a second growth curve [2]. Group 5: Key Companies - Notable companies in the Hong Kong innovative drug sector include: Heng Rui Medicine, Kelun-Botai Biological, and others [3]. - Leading companies in the CXO sector include: Kailai Ying, Kanglong Chemical, and others [4].