FDA CRL - Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Jiangsu Hengrui Pharmaceuticals Co., Ltd. has received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA 761308) for camrelizumab, stating the application cannot be approved in its present form. The main issues stem from unresolved deficiencies identified during a facility re-inspection, which require satisfactory responses to an FDA Form 483. The company must provide these responses and include their dates in the complete resubmission.

Additional concerns include the proposed prescribing information, carton and container labeling, and proprietary name, with further comments reserved until other deficiencies are resolved. Specifically, a mandatory Medication Guide statement must be added to carton and container labeling (per 21 CFR 208.24(d)). A comprehensive safety update is also required (under 21 CFR 314.50(d)(5)(vi)(b)), detailing new nonclinical and clinical safety data, including updated adverse event frequencies, reasons for trial discontinuation, case reports for serious events, updated exposure information, worldwide safety experience, and English translations of foreign labeling.

Jiangsu Hengrui is required to address all identified deficiencies and resubmit the application within one year, clearly marking it as a "RESUBMISSION." The company may also request a meeting with the FDA to discuss the necessary steps. The product cannot be legally marketed until written approval is issued by the FDA.