FDA CRL - Jiangsu Hengrui Pharmaceuticals Co., Ltd.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Jiangsu Hengrui Pharmaceuticals Co., Ltd. (via its U.S. agent, Hengrui U.S.A., Inc.) regarding their Biologics License Application (BLA) for SHR-1210. The FDA determined that the application cannot be approved in its current form due to several deficiencies.

Key issues include unresolved deficiencies identified during a pre-license inspection of a manufacturing facility. The company is required to provide the facility's response to the FDA Form 483, and a re-inspection may be necessary. Furthermore, due to travel restrictions, all Bioresearch Monitoring (BIMO) clinical inspections were not completed and are deferred until resubmission. Comments on proposed prescribing information, carton, container labeling, and the proprietary name are reserved until these primary issues are resolved.

To address these, Jiangsu Hengrui must submit a comprehensive safety update, as detailed in regulatory guidelines, including new safety data, updated exposure information, and a summary of worldwide safety experience. The company has one year to resubmit a complete response addressing all identified deficiencies, clearly marked as a "RESUBMISSION," or the application may be considered withdrawn. A meeting with the FDA can be requested to discuss the necessary steps for approval.