大量中成药将退出市场，业内人士：被淘汰的绝大部分是“僵尸品种”

Core Viewpoint - The upcoming regulatory changes in traditional Chinese medicine (TCM) are perceived as a necessary industry "slimming down," primarily targeting "zombie approvals" that have little to no market presence, rather than posing a significant threat to the overall market supply [1][3]. Regulatory Changes - The new regulations, effective from July 1, 2026, stipulate that if any safety information such as contraindications or adverse reactions remains "unclear" in the product's instructions after three years, the drug will not be eligible for re-registration [3][10]. - Most of the approvals expected to be eliminated are considered "zombie approvals," which are low-value, highly homogeneous products with negligible or zero market sales [3][4]. Industry Response - Industry insiders express that the costs associated with updating the required safety data are manageable, with estimates ranging from several thousand to tens of thousands of yuan per approval [4][7]. - Companies are likely to abandon these "zombie approvals" voluntarily, as they represent ongoing liabilities without significant market impact [5][9]. Market Dynamics - The real concern for the industry lies in the ongoing centralized procurement of TCM and the upcoming adjustments to the national essential drug list, which will significantly influence the core profits and survival of companies [10][11]. - The centralized procurement process, set to include 90 products with a market scale of over 45 billion yuan, raises questions about the future pricing and competitiveness of TCM products [10][11]. Future Outlook - The regulatory timeline provides a lengthy window for companies to adapt, with many already completing re-registration for key products [6][8]. - The adjustments to the essential drug list are anticipated to be more impactful than the registration regulations, as they will determine which products can access the main hospital channels [10][11].