从“数量扩张”向“质量优先”，院士专家回应中成药产业升级

Core Viewpoint - The Chinese traditional medicine industry is undergoing significant regulatory and market changes, leading to a rapid phase of industry reshuffling and upgrading as the deadline for new registration regulations approaches [1][2][4]. Regulatory Changes - The new regulations set to take effect on July 1, 2026, will require clear safety information on drug labels, pushing the industry towards higher quality standards and potentially leading to the delisting of products with ambiguous safety data [2][6]. - Current data indicates that over 40,000 of the 57,000 approved traditional Chinese medicine (TCM) products have unclear safety information, which will impact products with unclear clinical value and high safety risks [3][4]. Industry Dynamics - The dual pressures of funding and technology are intensifying the differentiation among companies, with larger firms able to invest in data compliance and mergers, while smaller firms struggle with funding and may abandon low-value licenses [4][5]. - The market share is expected to concentrate among high-quality enterprises, leading to a significant increase in industry concentration and a shift towards innovative and improved traditional medicines [4][5]. Market Performance - Recent earnings forecasts indicate a recovery in the TCM sector, with leading companies like Jiangzhong Pharmaceutical and Yiling Pharmaceutical showing significant profit growth, with Yiling expected to turn a loss of 7.25 billion yuan in 2024 into a profit of 1.2 to 1.3 billion yuan in 2025, marking a profit increase of up to 279.43% [7]. Quality and Pricing Trends - The upcoming centralized procurement and adjustments to the basic drug catalog are expected to accelerate industry upgrades, with a focus on quality over price, as the market will likely see a reduction in low-quality products [8][9]. - The new procurement process will include a comprehensive quality evaluation system to ensure that different manufacturers produce equivalent therapeutic effects and quality, addressing the challenges posed by the complexity of TCM ingredients [9].