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CStone Approved to Start China Clinical Trials of PD-1 Candidate

publication date: Jul 12, 2018

Suzhou CStone Pharma reported the China National Drug Administration (CNDA) has approved the first clinical trial application in China for CStone's PD-1 mAb, CS1003. CStone said the CNDA reviewed its filing under new rules, issuing a decision in just four months, dramatic proof of the agency's modernization of clinical trial approvals. CStone plans to start a multi-center China Phase I trial in patients with advanced cancers. CStone positioned CS1003 as a key part of the company's plan to develop combination immuno-therapy regimes for cancer. It is also developing a PD-L1 candidate. More details....

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