TASLY(SH:600535) Xin Lang Cai Jing·2026-02-13 07:14Core Viewpoint - Recently, the company Tian Shi Li announced the termination of its cooperation agreement with the US company Arbor, halting the joint plan for the compound Danshen dripping pill (T89) in the US market. Although the company stated it would recover related rights and receive $7.5 million, and that this would not have a significant impact on its production and operations, the event reflects the multifaceted risks and challenges faced by Tian Shi Li in the internationalization of traditional Chinese medicine, research and development progress, and corporate operations [1][4]. Group 1: Internationalization Strategy Challenges - The compound Danshen dripping pill has been under FDA clinical application in the US since 1998, making it a landmark project for the internationalization of traditional Chinese medicine. However, the termination of the partnership with Arbor signifies a setback in the strategy of leveraging local partners for market entry [5][6]. - Despite the company emphasizing its accumulated international clinical experience and that the application process is not entirely dependent on Arbor, the exit of the partner undoubtedly increases the uncertainty of its independent advancement. Currently, the two indications for the drug—chronic stable angina and acute altitude sickness—are still in phase III clinical trials, with no clear timeline for final approval [6]. Group 2: Research and Development Progress and Regulatory Risks - The approval process for the compound Danshen dripping pill in the US has been fraught with difficulties. In 2017, the FDA required the company to complete a second confirmatory clinical trial in addition to an already completed phase III trial, with both trials needing to achieve statistical significance (p<0.05). The first trial took about four years, and the second trial, which started in 2018, has exceeded four years without results [2][6]. - This prolonged and high-investment clinical process not only brings financial pressure but also reflects the stringent challenges faced by traditional Chinese medicine formulations under Western regulatory systems. If the results of the second clinical trial do not meet the standards, years of effort may be wasted. The company's "lone battle" in the internationalization of traditional Chinese medicine—where only a few traditional Chinese medicine products have attempted to navigate the FDA—also makes it difficult to learn from peers, leading to high trial-and-error costs [2][6]. Group 3: Operational Difficulties and Transformation Challenges - The journey of the compound Danshen dripping pill abroad mirrors the development trajectory of Tian Shi Li in recent years. The company's revenue approached 19 billion yuan between 2016 and 2019, but has since been under pressure due to the sale of its marketing subsidiary and the impact of medical insurance cost control and centralized procurement policies. In 2025, the company's revenue was 8.236 billion yuan, a year-on-year decline of 3.08%, while the net profit excluding non-recurring items was 786 million yuan, down 24.06% year-on-year, indicating a continued lack of growth momentum [2][7]. - Additionally, the company officially integrated into the China Resources Sanjiu system in 2025, which may provide resource support but also means that its original development strategy will face adjustments. In the context of weak growth in its main business and slow internationalization progress, how Tian Shi Li repositions its core competitive path will be a key question for its future development [7]. Conclusion - The "American dream" of the compound Danshen dripping pill remains unfulfilled, while Tian Shi Li has entered a new development cycle. From self-research challenges to setbacks in cooperation, and from peak performance to integration and transformation, the case of this leading traditional Chinese medicine enterprise illustrates that the internationalization of traditional Chinese medicine involves not only technical compliance and clinical data but also a multifaceted test of corporate strategic determination, financial endurance, and market adaptability. The company still needs to find a feasible path to bridge traditional Chinese medicine and modern pharmaceutical systems [3][8].