Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HENGRUI PHARMA) has announced that it recently received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for the combination therapy of Camrelizumab for Injection with Apatinib Mesylate Tablets as a first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma.

The regulatory feedback pertains primarily to observations from a Current Good Manufacturing Practice (CGMP) inspection of a production facility associated with Apatinib. This facility underwent an FDA CGMP surveillance inspection in April 2026. The company has conducted a detailed evaluation of the feedback provided by the regulatory agency and has initiated the formulation of corresponding corrective actions.

The relevant facility involved in this application successfully passed an inspection by the European Union in 2025. The CRL does not raise any issues concerning the clinical study data, safety, or efficacy of the product.

Hengrui Pharma will actively engage in close communication with the FDA and its partner, Elevar Therapeutics, to clarify the subsequent submission plan.