广东众生药业股份有限公司关于获得盐酸氨溴索口服溶液《药品注册证书》的公告

Core Viewpoint - The company has received the drug registration certificate for Ambroxol Hydrochloride Oral Solution, which is expected to enhance its market competitiveness and positively impact future performance [1][4]. Group 1: Drug Registration Information - The drug name is Ambroxol Hydrochloride Oral Solution, available in two specifications: 10ml: 30mg and 100ml: 0.3g [1]. - It is classified as a Class 4 chemical drug and has been approved for domestic production [1]. - The approval numbers are 2025S03794 and 2025S03795, with the drug approval document numbers being 国药准字H20256278 and 国药准字H20256279 [1]. Group 2: Product Overview - Ambroxol Hydrochloride is a mucolytic agent that helps reduce mucus viscosity and facilitates expectoration, making it suitable for treating acute and chronic bronchitis [2]. - The product is classified as a Category B drug under medical insurance and has shown sales growth in public hospitals and urban pharmacies in China, with total sales of RMB 71.084 million in 2022, RMB 81.766 million in 2023, and RMB 84.953 million projected for 2024 [2]. - This approval marks another product that has passed the consistency evaluation for generic drugs, complementing the company's existing respiratory medications [2]. Group 3: Impact on the Company - The approval of Ambroxol Hydrochloride Oral Solution is expected to enhance the company's market position and contribute positively to future performance [4]. - However, the sales performance may be influenced by national policies and market conditions, indicating a level of uncertainty [4].