Colum Pharmaceuticals' innovative tumor immunotherapy drug KL-A293 injections receive disservice to the National Drug Administration
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Last Update: 2020-06-08
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Source: Internet
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Author: User
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Today, Colum Pharmaceuticals announced that its holding soncompany(http://Columbotai and AnyuanPharmaceutical(http://to obtain thenotice of the NationalDrug(http://ClinicalTrial(http:// in the innovative tumor immunotherapy
drug(http://KL-A293 injections Drug Name: KL-A293 Injection Dosage Form: Injection Specifications: 200mg (10ml)/Bottle Registration Classification: Therapeutic Biologics 1 Declaration Stage: Clinical Applicants: Sichuan Columbotai Biopharmaceutical Co., Ltd., Anyuan Pharmaceuticals Technology (Shanghai) Co., Ltd Acceptance No.: CXSL1900067 Review Conclusion: In accordance with the Drug Administration Law of the People's Republic of China and the relevant provisions, after reviewing the KL-A293 injections meet the relevant requirements of drug registration, agree to carry out clinical trials of advanced solid tumors in accordance with the proposed program According to the New Drug (http:// Research and Development Monitoring Database (CPM) and Drug Sharing Plus, the clinical application for KL-A293 injections was approved by CDE on July 9, 2019 and the drug was implicitly licensed for CDE clinical trials on September 10 KL-A293 injection is a second-generation tumor immunocheckpoint inhibitor with independent intellectual property rights developed by Columbotai and Anyuan Pharmaceuticals, and its mechanism is clear and intended for treatment of advanced malignant tumors The results show that KL-A293 injection sits anti-tumor activity in tumor animal models, has good pharmacokinetic characteristics, and has good safety and tolerance
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