熊去氧胆小檗碱(HTD1801)

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君圣泰医药刘利平:深耕创新药领域 破局代谢共病化
Shang Hai Zheng Quan Bao· 2025-07-30 18:03
Core Viewpoint - Junshengtai Pharmaceutical is innovating in the treatment of chronic metabolic diseases by developing a multi-target drug, HTD1801, derived from natural products, combining berberine and ursodeoxycholic acid to provide comprehensive benefits for patients [2][3][4]. Group 1: Company Background and Development - Liu Liping, the founder and CEO of Junshengtai Pharmaceutical, has over a decade of experience in drug development, including leading new drug applications and clinical trials abroad [3]. - The company was established in 2011, focusing on developing innovative drugs that address chronic metabolic diseases through a multi-target approach rather than single-target drugs [3][4]. - The decision to return to China and start the company was influenced by the government's emphasis on developing the biopharmaceutical industry as a strategic emerging industry [3]. Group 2: Drug Development Process - The active ingredients selected for HTD1801 are berberine, known for its anti-inflammatory and blood sugar regulation properties, and ursodeoxycholic acid, which has a long history of clinical application [4][6]. - Initial attempts to combine these two compounds faced challenges, including a failed collaboration with a Boston laboratory, but perseverance led to the successful development of a new molecular entity [6][7]. - The combination of berberine and ursodeoxycholic acid has shown synergistic effects, enhancing efficacy while reducing toxicity, which is a significant advancement in drug development [7]. Group 3: Clinical and Market Potential - HTD1801 is being developed for multiple indications, including type 2 diabetes, metabolic-associated fatty liver disease, chronic kidney disease, and obesity, aiming to address the clinical need for multi-disease treatment [8]. - The drug has gained recognition in the international academic community, with research results presented at major conferences and published in high-impact journals, affirming its scientific value [8]. - In 2018, HTD1801 received fast track designation from the FDA for non-alcoholic steatohepatitis, marking it as the first Chinese innovative drug to achieve this status in the field [8]. Group 4: Company Growth and Future Plans - Junshengtai Pharmaceutical has established a product pipeline with global intellectual property rights, including seven potential leading drugs covering nine indications [9]. - The company plans to submit a new drug application for HTD1801 to the National Medical Products Administration in China within the year, marking its entry into the commercialization phase [9]. - The company went public on the Hong Kong Stock Exchange in 2023, with significant oversubscription during the public offering, indicating strong market interest and confidence in its growth potential [8][9].