孟鲁司特被要求新增警示语，去年前三季度销售额超13亿元

Core Viewpoint - The National Medical Products Administration (NMPA) of China has mandated the addition of warnings regarding neuropsychiatric adverse reactions in the instructions for Montelukast formulations, including serious reactions such as depression and suicidal tendencies, with a deadline for compliance set for March 12, 2026 [1][4]. Group 1: Regulatory Changes - The NMPA requires all Montelukast product license holders in China to revise their product instructions to include warnings about neuropsychiatric adverse reactions [1]. - The revisions must be submitted to the NMPA or provincial drug regulatory departments by March 12, 2026, and all existing product labels must be updated within nine months after the submission [1]. Group 2: Market Context - Montelukast sodium, originally developed by Merck (brand name: Singulair), is a potent selective leukotriene receptor antagonist used for asthma prevention and treatment in children aged 2 to 14 [3]. - Following the expiration of Merck's patent, domestic companies have begun to produce generic versions, with 62 approvals found on the NMPA website from various manufacturers [3]. Group 3: Adverse Reactions and Clinical Implications - The revision of Montelukast's instructions is based on adverse reaction assessments, with the FDA in the U.S. having previously issued a black box warning for similar neuropsychiatric adverse reactions [4][5]. - Reports of adverse reactions, including depression and suicidal behavior, have been documented, with a study indicating that 86.12% of Montelukast prescriptions in a certain hospital were for off-label uses [5][8]. Group 4: Sales and Competitive Landscape - Montelukast ranked third in sales among asthma medications in China for the first three quarters of 2024, with total sales reaching 1.33 billion yuan [9]. - The competitive landscape includes 24 companies with 42 formulations of Montelukast available, with significant market shares held by companies like Eurofarma and Shanghai Anbisen [9]. Group 5: Emerging Treatments - The emergence of biologic therapies is changing the treatment landscape for pediatric asthma, with several new biologics approved for use in children [10]. - The NMPA's revisions to Montelukast's labeling serve as a reminder for the need for safe and effective prescribing practices as new treatment options become available [10].