天士力复方丹参滴丸出海美国再受挫

Core Viewpoint - Tianshili has terminated its collaboration with Arbor Pharmaceuticals, impacting the U.S. market expansion plan for its compound Danshen dripping pill (T89), which was a key project for the internationalization of traditional Chinese medicine [1][4]. Group 1: Collaboration Termination - The termination of the partnership with Arbor was due to Arbor's acquisition by Azurity and subsequent business adjustments, leading to the end of the U.S. market cooperation plan for T89 [1][4]. - Tianshili will receive a payment of $7.5 million as part of the termination agreement and will regain exclusive sales rights for T89 in the U.S. [1][4]. - The company stated that this termination will not significantly impact its project advancement, production operations, or financial status [1][4]. Group 2: Historical Context of T89 - The internationalization of T89 began in 1998 when it was officially approved for clinical research by the U.S. FDA [3]. - T89 received FDA approval for indications related to chronic stable angina and acute altitude sickness in 2006 and 2018, respectively [4]. - Tianshili and Arbor signed a licensing agreement in September 2018, with Arbor committing up to $23 million for research and obtaining exclusive sales rights for T89 in the U.S. [4]. Group 3: Clinical Trials and Regulatory Challenges - Tianshili has accumulated significant overseas clinical trial experience prior to the collaboration with Arbor, having completed a large-scale Phase III clinical trial [4][5]. - The success of T89's U.S. market entry hinges on obtaining regulatory approval based on clinical data, with the product still awaiting approval [5][6]. - Tianshili is currently conducting two Phase III clinical trials for T89, with the results of the second trial being crucial for U.S. approval [6][9]. Group 4: Company Performance and Market Position - Tianshili is a leading company in the modern Chinese medicine sector, listed on the Shanghai Stock Exchange since 2002 [7]. - T89 is Tianshili's most recognized product, achieving sales of over 3.3 billion yuan in 2015 and maintaining its position as the top-selling traditional Chinese medicine product for 13 consecutive years [8]. - The company has faced declining revenues since 2020, with total revenue of 8.236 billion yuan in 2025, a decrease of 3.08% year-on-year, and a net profit decline of 24.06% [11].