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China Clinical CROs & IIT Partners · Industry updates

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CSPC Pharmaceutical Group

CSPC initiates first Chinese center for SYS6055-003 in vivo CAR-T trial

CSPC announced initiation of the first Chinese center for SYS6055-003, a Phase 1/2 trial in relapsed or refractory B-cell non-Hodgkin lymphoma. SYS6055 uses lentiviral vectors to generate CD19-targeting CAR-T cells in vivo. The company said recruitment and screening are underway following October clinical-trial authorization. Center initiation does not establish patient dosing, efficacy, or marketing approval.

China National Center for Biotechnology Development

China publishes fifteenth batch of biomedical clinical research filings

The China National Center for Biotechnology Development published its fifteenth batch of biomedical clinical research filings on November 4. Seven projects completed filing between October 27 and November 4. The notice emphasizes institutional responsibility, internal quality management, training, data traceability, and participant protection. Filing concerns the research pathway; it is not evidence of therapeutic efficacy or product marketing authorization.

Clinical Trials

Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study

Historical methods study (2017): 213 sites from 11 academic trials were randomised; audits covered 156 sites and 1,618 patients. Risk-adapted monitoring met the specified non-inferiority criterion for major audit findings while using fewer resources. High-risk trials were excluded. The findings inform monitoring design, not the performance of any Chinese CRO.

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