At noon on July 10, Hengrui Pharmaceutical issued an announcement stating that the company received a full response letter from the US Food and Drug Administration regarding the licensing application of the drug Rivoceranib for first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma with carrilizumab and its partner Elevar Therapeutics. This means that once again, the FDA has delayed approval for marketing of this combination therapy. In response, Hengrui Pharmaceutical said that the FDA approval feedback is mainly related to CGMP inspection observations at the production site related to apatinib. The site was subject to FDA CGMP supervision and inspection in April 2026. The company has made a detailed evaluation of the feedback submitted by the regulatory authorities and has begun formulating corresponding improvement measures. The relevant venue covered by this declaration passed the EU inspection in 2025. Hengrui Pharmaceutical also stated that the current CRL did not address issues with regard to clinical research data, safety and efficacy of the product. The company will actively communicate closely with the FDA and partner Elevar Therapeutics to clarify subsequent filing plans. Steady promotion of internationalization is the company's long-term development strategy, and the company's overseas research and development process for many innovative drugs continues to advance according to the plan.

At noon on July 10, Hengrui Pharmaceutical issued an announcement stating that the company received a full response letter from the US Food and Drug Administration regarding the licensing application of the drug Rivoceranib for first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma with carrilizumab and its partner Elevar Therapeutics. This means that once again, the FDA has delayed approval for marketing of this combination therapy. In response, Hengrui Pharmaceutical said that the FDA approval feedback is mainly related to CGMP inspection observations at the production site related to apatinib. The site was subject to FDA CGMP supervision and inspection in April 2026. The company has made a detailed evaluation of the feedback submitted by the regulatory authorities and has begun formulating corresponding improvement measures. The relevant venue covered by this declaration passed the EU inspection in 2025. Hengrui Pharmaceutical also stated that the current CRL did not address issues with regard to clinical research data, safety and efficacy of the product. The company will actively communicate closely with the FDA and partner Elevar Therapeutics to clarify subsequent filing plans. Steady promotion of internationalization is the company's long-term development strategy, and the company's overseas research and development process for many innovative drugs continues to advance according to the plan.