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Good news for pharmaceutical companies in BDA

Updated: 2021-08-26

The first subject of the Phase I clinical study of the fourth-generation EGFR inhibitor BPI-361175 project of Betta Pharmaceuticals was enrolled

Recently, the first subject of the Phase I clinical study of the BPI-361175 project of Betta Pharmaceuticals was successfully enrolled, and the first administration was successfully completed. 

The full name of the study is "a dose-escalation, open phase I/II study to evaluate the safety, tolerability, pharmacokinetics, and effectiveness of BPI-361175 tablets in patients with advanced solid tumors." 

The main investigator is Professor Zhou Caicun of the Shanghai Pulmonary Hospital. 

The phase I study includes two parts: dose escalation and enrollment expansion. 

Its main target is to evaluate the safety and tolerability of BPI-361175 for patients with advanced non-small-cell lung cancer, and to explore the maximum tolerated dose (MTD) and dose-limiting toxicity (DLTs), to determine the recommended dose for later clinical studies, and evaluate the preliminary efficacy.

ChosenMed passed the 2021 National Tumor Somatic Mutation High-throughput Sequencing and Bioinformatics Analysis Laboratory Quality Evaluation

Recently, the National Center for Clinical Laboratories (NCCL) announced the quality evaluation results of the bioinformatics analysis for the national high-throughput sequencing detection of tumor somatic mutations in 2021. 

Hangzhou ChosenMed, a subsidiary of Qiuzhen Medical, passed this external quality assessment with a perfect score. This is a reaffirmation of the ability of ChosenMed Laboratory to detect somatic mutations in bioinformatics analysis.

The Phase I clinical center jointly built by JOINN Laboratories and Taicang Hospital Affiliated to Soochow University is put into use

The Phase I clinical center of Taicang First People's Hospital, co-built by JOINN Laboratories and Taicang Hospital Affiliated to Soochow University, has been completed and put into use.

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The Phase I clinical center of Taicang First People's Hospital [Photo/kfqgw.beijing.gov.cn]

The center has 71 research beds, an informed consent room, a screening room, a drug store, a subject activity room, a catering room, a biological sample disposal/preservation room, a CRA office, a file room, and a rescue unit, and is fully equipped to ensure the safety of subjects.