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中成药出清将主要影响两类药品
21世纪经济报道· 2026-01-29 08:01
Core Viewpoint - The Chinese traditional medicine (CTM) industry is undergoing significant regulatory and market changes, leading to a phase of "low-quality" product elimination and industry upgrade as the deadline for new registration regulations approaches [1][2][4]. Regulatory Changes - The new regulations, effective from July 1, 2026, will require clear safety information on CTM product labels, with products marked as "unclear" facing delisting [1][4]. - A significant number of CTM approvals, approximately 40,000, currently lack essential safety information, which will impact products with unclear clinical value and high safety risks [4]. Industry Dynamics - The dual pressure of funding and technology is intensifying the differentiation among industry players, with leading companies able to enhance their core products and acquire quality approvals, while smaller firms struggle with funding and research capabilities [5]. - The industry landscape is expected to fundamentally change post-regulation, with a reduction in ineffective approvals and a concentration of market share among high-quality enterprises [5][6]. Market Trends - The market for CTM is anticipated to shift towards high-quality development, focusing on classic formulations and innovative products, while the concentration of market share will increase as low-market-share products exit [8][9]. - Recent performance reports indicate a recovery in the CTM sector, with leading companies like Jiangzhong Pharmaceutical and Yiling Pharmaceutical showing significant profit growth due to cost improvements and marketing reforms [9][10]. Pricing and Competition - The upcoming centralized procurement process is expected to enhance market competition, leading to potential cost reductions for high-quality products as low-quality options are phased out [8][11]. - The new procurement regulations will include a comprehensive quality evaluation system to ensure that different manufacturers' products meet consistent efficacy and quality standards [12].