盐酸氨溴索原研药沐舒坦将重返中国市场

Core Viewpoint - The return of the original brand Mucosolvan (Ambroxol Hydrochloride) to the Chinese market is anticipated in December 2025, following its exit due to registration expiration and increased competition from generic drugs [1][2]. Group 1: Company Background - Mucosolvan was originally developed by Boehringer Ingelheim and launched in Germany in 1978, entering the Chinese market in 1991 [2]. - The product achieved peak sales exceeding 8 billion yuan in China, making it a highly competitive product in the market [2]. - The original manufacturer, Boehringer Ingelheim, ceased the product's registration in China in 2020, leading to its market exit [3]. Group 2: Market Competition - The return of Mucosolvan will face competition from 367 similar drug approvals in China, including significant price competition from generics [6]. - In the 2021 centralized procurement, Boehringer Ingelheim's bid was only a 0.3% price reduction, while competitors like Yunnan Longhai offered a 93.3% reduction [4]. - The market for expectorants is crowded, with other active ingredients available, such as bromhexine and acetylcysteine, which may affect Mucosolvan's market share [6]. Group 3: Future Outlook - The product's return is now under the management of Opella, a company that became independent from Sanofi in May 2025, which retains a 48.2% stake in Opella [4]. - The ability of Mucosolvan to regain consumer trust and willingness to pay a premium in a low-price environment remains uncertain [6]. - The performance of Mucosolvan post-return will be closely monitored, especially regarding its positioning in the OTC market [6].