Notice of Clinical Trial Approval for Recombinant Human Adenovirus 5 Injection of Shanghai Pharmaceuticals Group Co., Ltd. Restructuring

Recombinant human adenovirus type 5 injection (trade name: Ankrui) is an oncolytic adenovirus anti-tumor drug that contains recombinant adenoviruses that can specifically replicate in tumor cells, cause tumor cell damage, lysis, and further activate immune responses to exert anti-tumor effects. Ankeri was approved for marketing in China in 2005, with an approved indication for advanced nasopharyngeal carcinoma

Recombinant human adenovirus type 5 injection (trade name: Ankrui) is an oncolytic adenovirus anti-tumor drug that contains recombinant adenoviruses that can specifically replicate in tumor cells, cause tumor cell damage, lysis, and further activate immune responses to exert anti-tumor effects. Ankeri was approved for marketing in China in 2005, with an approved indication for advanced nasopharyngeal carcinoma. The clinical trial application for the indication of malignant ascites by Ankeri was officially accepted by the National Drug Administration on April 18, 2023. Recently, the project was approved by the National Drug Administration to issue a "Drug Clinical Trial Approval Notice", agreeing to carry out clinical trials for the treatment of malignant ascites.

As of the disclosure date of this announcement, the project has invested a total of approximately RMB 10.0057 million in research and development expenses.

According to the laws and regulations related to drug registration in China, after obtaining a clinical trial notice, this project still needs to conduct clinical trials and be reviewed and approved by the National Drug Administration before applying for the listing of new indications.

Xiaoxiang Morning News Comprehensive

Disclosure and rights protection channels: Download the "Morning Video" client from the application market, search for "Help" and directly reach the "Chenyi Help" platform with one click; Or call the hotline 0731-85571188. Government Enterprise Content Service Special Chair 19176699651.

Disclaimer: The content of this article is sourced from the internet. The copyright of the text, images, and other materials belongs to the original author. The platform reprints the materials for the purpose of conveying more information. The content of the article is for reference and learning only, and should not be used for commercial purposes. If it infringes on your legitimate rights and interests, please contact us promptly and we will handle it as soon as possible! We respect copyright and are committed to protecting it. Thank you for sharing.(Email:[email protected])