Genscript Unit Wins China’s First Approval for Human Trials of Blood Cancer Therapy

Genscript Unit Wins China’s First Approval for Human Trials of Blood Cancer Therapy

Dou Shicong

Date: Tue, 03/13/2018 - 17:31 / source:Yicai
Genscript Nanjing Becomes First Firm in China to Get Greenlight to Advance Its CAR-T Cell Therapy
Genscript Nanjing Becomes First Firm in China to Get Greenlight to Advance Its CAR-T Cell Therapy

(Yicai Global) March 13 -- A subsidiary of Genscript Biotech Corp. has become the first company to secure the green light from China’s food and drug regulator to start clinical trials of an innovative blood cancer therapy that involves modifications to a patient’s own immune cells.

Genscript Nanjing Ltd. was the first to apply for human trials in China for its CAR-T therapy last December and completed technical reviews of pharmacology, toxicology, pharmacy and clinical trials in January, the China Food and Drug Administrator said on its website today.

So far, nearly 15 other Chinese pharmaceutical companies have applied to conduct clinical trials of CAR-T therapies. They include Anhui Anke Biotechnology Group Co., Jiangsu Hengrui Medicine Co., and Chongqing Zhifei Biological Products Co. They have yet to complete the technical review stage.

CAR-T therapy, or Chimeric Antigen Receptor T-Cell Immunotherapy, is claimed to have significant curative effects on leukemia and lymphoma and is regarded as one of the most promising ways of treating malignant tumors.

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Keywords: Genscript, CAR-T, CFDA, Tumor, Cancer Treatment