Hengrui Pharma (“the Company”) recently received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application for camrelizumab, an anti-PD-1 antibody, in combination with rivoceranib, an oral VEGF-TKI, for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma.

The FDA's decision was related to deficiencies identified during a CGMP surveillance inspection of a manufacturing site associated with rivoceranib, which underwent an FDA CGMP surveillance inspection in April 2026. The Company has conducted a thorough assessment of the feedback provided by the FDA and has begun formulating corresponding corrective measures.

This CRL does not involve any issues relating to the product's clinical study data, safety or efficacy. The Company will maintain close communication with the FDA and its partner, Elevar Therapeutics, to ascertain the subsequent filing plan.