药品集采规则“升级”，如何影响医药行业？

Core Viewpoint - The 11th batch of national centralized drug procurement emphasizes clinical stability, quality assurance, prevention of collusion, and reduction of internal competition, with 55 drug varieties included in the procurement scope, set to open bids on October 21 in Shanghai [1] Group 1: Innovations in Procurement - The procurement process allows medical institutions to report quantities based on specific brands rather than just generic names, aligning supply with clinical needs [2] - New requirements for bidding qualifications include a minimum of two years of production experience for the drug's license holder or contract manufacturer, and compliance with GMP standards [3] Group 2: Changes in Selection Rules - The selection rules have been significantly adjusted to avoid solely relying on the lowest bid, introducing a benchmark price that requires bids to be at least 50% of the average comparable price [4] - Two conditions for obtaining selection qualifications are established, including a maximum price threshold based on the benchmark price [5] Group 3: Revival Mechanisms - A revival mechanism allows previously disqualified bidders to gain selection if they accept the highest proposed price determined by the rules [6] - A new revival rule for non-selected enterprises is introduced, allowing them to qualify under specific conditions related to demand and pricing [7][8][9] Group 4: Anti-Collusion Measures - An anti-collusion mechanism is introduced, offering leniency to the first entity that provides evidence of collusion or admits to participation in collusion [10] Group 5: Industry Impact - The 11th batch of procurement marks a shift from broad price reductions to refined management, focusing on quality and supply assurance while avoiding excessive price competition [11] - The new rules delineate a clear boundary for innovative drugs, allowing generic drugs to face price competition while protecting patented innovative drugs [11] - The emphasis on innovation and internationalization is expected to enhance the competitiveness of innovative drugs in both domestic and international markets [11] - Companies with strong R&D capabilities and diversified product lines are recommended for attention, alongside those benefiting from the procurement process [12]