重庆华森制药股份有限公司关于公司药品生产许可证变更的公告

Core Viewpoint - Chongqing Huason Pharmaceutical Co., Ltd. has received a change in its drug production license, extending the contract manufacturing period for Montelukast Sodium Granules until March 2, 2026, which is expected to enhance the company's production capacity utilization [1][3]. Group 1: License Change Details - The change involves the extension of the contract manufacturing period for Montelukast Sodium Granules, a product commissioned by Youhua Pharmaceutical Technology Co., Ltd. [1]. - The new drug production license number is 渝20150018, issued by the Chongqing Drug Administration [1]. Group 2: Product Information - Montelukast Sodium Granules are indicated for the prevention and long-term treatment of asthma in children over one year old, as well as for alleviating symptoms of allergic rhinitis in children aged 2 to 5 [2]. - The product is classified as a national medical insurance category B product and is recommended in several authoritative clinical guidelines, highlighting its significant market presence and advantages in pediatric formulations [2]. Group 3: Market Performance - The overall market for Montelukast Sodium has reached maturity, but the granule formulation for children continues to show strong growth potential [2]. - In the past five years (2020-2024), the cumulative sales of Montelukast Sodium formulations in domestic hospital terminals have reached 5.545 billion yuan [2]. Group 4: Impact on the Company - The change in the drug production license is expected to improve the company's production capacity utilization, although it will not have a significant short-term impact on the company's performance [3].