HENGRUI PHARMA (01276.HK): Receives CRL from FDA for Camrelizumab Liver Cancer Indication, Related to cGMP Inspection Findings at Apatinib Manufacturing Site

NewTimeSpace · 2026/07/10 16:43 · By Jiayi Sun

NewTimeSpace News: HENGRUI PHARMA (01276.HK) announced on 10 July that it has received a Complete Response Letter (CRL) from the US FDA regarding the BLA for camrelizumab for injection combined with apatinib as first-line treatment of unresectable or metastatic hepatocellular carcinoma. The feedback mainly concerns cGMP inspection observations at the apatinib manufacturing site and does not involve clinical data, safety or efficacy issues. Final analysis of the CARES-310 trial demonstrated median overall survival of 23.8 months, the longest median OS reported for first-line liver cancer treatment to date. The Group will communicate actively with the FDA and partner Elevar Therapeutics to clarify next submission plans, while noting there is uncertainty over approval.

NewTimeSpace News: On 10 July 2026, HENGRUI PHARMA (01276.HK) issued an announcement. The Company received a Complete Response Letter (CRL) from the US FDA for the Biologics License Application (BLA) of camrelizumab for injection in combination with apatinib for first-line treatment of unresectable or metastatic hepatocellular carcinoma.

The feedback primarily relates to observations identified during the FDA cGMP inspection at the apatinib manufacturing site, which underwent FDA inspection in April 2026. The Company has assessed the findings and started formulating corrective actions. The same manufacturing facility passed an EU inspection back in 2025.

The CRL contains no questions regarding clinical study data, product safety or efficacy. Final analysis of the CARES-310 study showed the combination regimen achieved a median overall survival of 23.8 months, representing the longest median OS observed for any first-line hepatocellular carcinoma therapy so far. The Company stated it will engage constructively with the FDA and partner Elevar Therapeutics to define follow-up submission strategies. There can be no assurance that the application will ultimately receive approval.

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