Hengrui Pharmaceuticals responds to the delay in approval of PD-1 combination therapy in the United States: No clinical research data issues involved.

On July 10th at noon, Hengrui Pharmaceuticals announced that the company had received a complete response letter from the US Food and Drug Administration regarding the biologics license application for Rivoceranib, a drug co-developed with partner Elevar Therapeutics, for the first-line treatment of unresectable or metastatic hepatocellular carcinoma patients. This means that the joint therapy has once again been delayed in receiving FDA approval for market launch. In response to this, Hengrui Pharmaceuticals stated that the FDA feedback mainly pertains to observations related to the CGMP inspection of the production site for apatinib, which underwent an FDA CGMP supervision inspection in April 2026. The company has conducted a detailed evaluation of the feedback provided by regulatory authorities and has begun to formulate appropriate improvement measures. The relevant site involved in this application passed an inspection by the European Union in 2025. Hengrui Pharmaceuticals also stated that the CRL this time did not involve issues regarding the product's clinical trial data, safety, and effectiveness. The company will actively communicate closely with the FDA and partner Elevar Therapeutics to clarify the future application plan. Continuously advancing internationalization is a long-term development strategy for the company, and the overseas research and development processes for several innovative drugs are progressing as planned.