Overview
- The FDA sent a Complete Response Letter that blocks approval of rivoceranib because a routine cGMP inspection of the Jiangsu Hengrui manufacturing site produced a Form 483 with inspectional observations.
- Elevar and HLB say the CRL does not challenge the safety or efficacy data for the rivoceranib plus camrelizumab regimen and does not ask for additional clinical trials.
- Elevar has formally asked Hengrui for the Form 483, Hengrui’s responses to the FDA, and a timeline for corrective actions and HLB is reviewing those materials to shape a resubmission plan.
- HLB’s stock fell sharply to the KOSDAQ daily limit following the CRL, and the company said this marks another regulatory setback in its long-running push for U.S. approval.
- Regulators must be shown that cGMP problems are fixed before approval can move forward, which could trigger a preapproval inspection and create uncertainty over timing and patient access to the treatment.