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歌禮製藥-B：自願性公告 - 歌禮宣佈有關FXR激動劑ASC42的戰略決定

ASCLETIS-B: VOLUNTARY ANNOUNCEMENT - ASCLETIS ANNOUNCES STRATEGIC DECISIONS ON FXR AGONIST ASC42

香港交易所 ·  Apr 3 05:00
Summary by Moomoo AI
歌禮製藥有限公司（「歌禮」）宣佈，經過對法尼醇X受體(FXR)激動劑ASC42進行的II期臨床試驗數據全面分析後，決定不再繼續開展該藥物治療原發性膽汁性膽管炎（PBC）的臨床試驗。此決策基於12周II期研究的療效和安全性數據，該數據顯示ASC42與其他處於開發階段的PBC候選藥物相比未顯示出競爭優勢。同時，歌禮亦決定不再進行ASC42聯用治療非酒精性脂肪性肝炎（NASH）的臨床研究，以及ASC42治療乙肝的臨床研究。公司表示，這些決策是為了優化研發管線，提高效率和保存現金。節省下來的資金將用於加速推進ASC41和ASC40的NASH適應症臨床研究及研發。ASC41和ASC40在臨床試驗中均顯示出積極結果，ASC41有望成為同類最佳的甲狀腺激素受體β(THRβ)激動劑，而ASC40在NASH緩解和纖維化改善方面取得了統計學顯著性結果。截至2023年12月31日，歌禮的現金及現金等價物以及定期存款約為23億人民幣。
歌禮製藥有限公司（「歌禮」）宣佈，經過對法尼醇X受體(FXR)激動劑ASC42進行的II期臨床試驗數據全面分析後，決定不再繼續開展該藥物治療原發性膽汁性膽管炎（PBC）的臨床試驗。此決策基於12周II期研究的療效和安全性數據，該數據顯示ASC42與其他處於開發階段的PBC候選藥物相比未顯示出競爭優勢。同時，歌禮亦決定不再進行ASC42聯用治療非酒精性脂肪性肝炎（NASH）的臨床研究，以及ASC42治療乙肝的臨床研究。公司表示，這些決策是為了優化研發管線，提高效率和保存現金。節省下來的資金將用於加速推進ASC41和ASC40的NASH適應症臨床研究及研發。ASC41和ASC40在臨床試驗中均顯示出積極結果，ASC41有望成為同類最佳的甲狀腺激素受體β(THRβ)激動劑，而ASC40在NASH緩解和纖維化改善方面取得了統計學顯著性結果。截至2023年12月31日，歌禮的現金及現金等價物以及定期存款約為23億人民幣。
Song Pharmaceutical Co., Ltd. (“Song”) announced that it has decided to no longer pursue clinical trials of the drug for the treatment of primary biliary cholecystitis (PBC) after a comprehensive analysis of Phase II clinical trial data for the treatment of the drug, ASC42. This decision is based on efficacy and safety data from a 12-week Phase II study, which showed that ASC42 showed no competitive advantage over other PBC candidate drugs in development. At the same time, Song also decided to no longer conduct clinical trials for ASC42 for the treatment of non-alcoholic fatty hepatitis (NASH) and ASC42 for the treatment of hepatitis B. The company said the decisions were to optimize R&D pipelines, improve efficiency and conserve cash. The funds...Show More
Song Pharmaceutical Co., Ltd. (“Song”) announced that it has decided to no longer pursue clinical trials of the drug for the treatment of primary biliary cholecystitis (PBC) after a comprehensive analysis of Phase II clinical trial data for the treatment of the drug, ASC42. This decision is based on efficacy and safety data from a 12-week Phase II study, which showed that ASC42 showed no competitive advantage over other PBC candidate drugs in development. At the same time, Song also decided to no longer conduct clinical trials for ASC42 for the treatment of non-alcoholic fatty hepatitis (NASH) and ASC42 for the treatment of hepatitis B. The company said the decisions were to optimize R&D pipelines, improve efficiency and conserve cash. The funds saved will be used to accelerate the advancement of clinical research and development of NASH indications for ASC41 and ASC40. ASC41 and ASC40 both showed positive results in clinical trials, with ASC41 expected to be the best-in-class thyroid hormone receptor β (THRβ) activator, and ASC40 achieved statistically significant results in NASH mitigation and fibrosis improvement. As of December 31, 2023, the cash and cash equivalents of the song, as well as fixed deposits, are approximately RMB 23 billion.

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