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贵州百灵(002424.SZ):替芬泰片与恩替卡韦片相互作用临床研究获伦理审查批件

Guizhou Bailing (002424.SZ): Clinical study on the interaction between tifentai tablets and entecavir tablets obtained ethical review approval

Zhitong Finance ·  Dec 27, 2023 05:40

Guizhou Bailing (002424.SZ) issued an announcement. Recently, the company received Beijing You'an Hospital affiliated to Capital Medical University...

Zhitong Finance App News, Guizhou Bailing (002424.SZ) issued an announcement. Recently, the company received an “Ethical Review Approval” from Beijing You'an Hospital affiliated to Capital Medical University. The name of the trial/research project is clinical study on the interaction between tifentai tablets and entecavir tablets.

Based on the experimental results, after repeated communication with the National Drug Evaluation Center (CDE), the company plans to locate patients with chronic hepatitis B with low surface antigen (HBsAg) levels after long-term NAS treatment through phase II clinical trials. Based on communication opinions, on the basis of ensuring patient benefits, it was decided to use NAs as the base drug for the treatment of hepatitis B “Big Sanyang” and “Xiao Sanyang” and chronic hepatitis B patients with low surface antigens after long-term NAs treatment. On the basis of completing the “13 consecutive weeks of repeated oral administration toxicity test study on SD rats” to ensure safety, this clinical trial of the drug interaction between tifentaib tablets and entecavir tablets was carried out immediately. Explore the clinical functional cure of tefentam tablets to address unmet clinical needs.

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