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# Agency Sends 3rd Complete Response on Hengrui, Elevar NDA
- URL: https://www.fdaweb.com/agency-sends-3rd-complete-response-on-hengrui-elevar-nda/
- Published: 2026-07-10T12:00:00.000Z
- Updated: 2026-09-14T13:42:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161437

Hengrui Pharma and Elevar Therapeutics have received a third FDA complete response letter (CRL) for their combination of camrelizumab and rivoceranib for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC), with the agency again citing manufacturing deficiencies rather than concerns about the therapy's clinical performance.

The CRL, disclosed by Elevar on 7/10, represents the latest setback for a program that has now failed to secure FDA approval after three review cycles spanning more than two years. According to the company, the agency's action was based on GMP observations identified during an April inspection of a Hengrui manufacturing facility in China that produces camrelizumab. The letter did not identify deficiencies related to the efficacy or safety data supporting the application and did not request an additional clinical trial, according to the company.

The latest decision follows two previous CRLs issued 5/2024 and 3/2025\. The initial rejection cited manufacturing deficiencies at the camrelizumab production site, while the second CRL came after the companies resubmitted the application.

The recurring manufacturing issues have made the program one of the most prominent examples of FDA's increasingly stringent scrutiny of manufacturing compliance in oncology reviews.

Elevar said it is seeking additional documentation from Hengrui, including the FDA Form 483 issued following the April inspection, the company's responses to the agency, and its corrective action plan. The companies said they intend to work with FDA and resubmit the application as quickly as possible once the manufacturing issues have been addressed.

The submission is based on data from the Phase 3 CARES-310 trial, which demonstrated statistically significant improvements in overall survival and progression-free survival compared with sorafenib in patients with unresectable HCC, the company says. The combination has been recognized in several international treatment guidelines based on those data, but the manufacturing deficiencies have repeatedly prevented FDA from approving the regimen for the U.S. market.