Hengrui and Elevar's Liver Cancer Combo Suffers Third FDA Rejection Over Manufacturing Deficiencies
On July 10, 2026, the FDA issued a third Complete Response Letter (CRL) declining to approve Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics' combination of camrelizumab (anti-PD-1) and rivoceranib (a VEGFR2 inhibitor, also known as apatinib) as a first-line treatment for unresectable hepatocellular carcinoma (liver cancer).
The latest rejection is a major setback for the partners, who first submitted the combination for FDA approval over two years ago.
Manufacturing Issues Shift to Rivoceranib Facility
While the first two FDA rejections (in May 2024 and March 2025) centered on manufacturing deficiencies at Hengrui's camrelizumab production plant, this third CRL stems from compliance issues at the facility producing rivoceranib.1 The deficiencies were identified during an FDA inspection in April 2026.
Hengrui and Elevar emphasized that the CRL did not raise any concerns regarding the clinical efficacy or safety data of the combination. The resubmission was supported by updated final analysis from the Phase 3 CARES-310 trial, showing a 36% reduction in the risk of death compared to sorafenib (Nexavar).
Both companies have stated they are actively working to address the deficiencies and plan to coordinate with the FDA for a subsequent resubmission, which may require an agency re-inspection.
Context of Chinese PD-1 Hurdles in the U.S.
The ongoing struggles of the camrelizumab-rivoceranib combo reflect a broader pattern of regulatory and operational hurdles faced by Chinese biotes and pharmaceutical companies attempting to bring PD-1 checkpoint inhibitors to the highly lucrative U.S. market. This has historically included FDA pushback on China-only clinical trial data, as well as persistent manufacturing compliance issues.
"The company has thoroughly evaluated the regulator’s feedback and is taking steps to implement appropriate corrective measures... The company will actively communicate with the FDA and our partner, Elevar Therapeutics, to establish the next resubmission plan." — Jiangsu Hengrui Pharmaceuticals, Shanghai Securities Filing
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An instance of Flawless clinical profiles cannot salvage a drug from manufacturing facility failures. — A highly effective liver cancer therapy remains blocked in the U.S. due to persistent compliance and facility deficiencies at its manufacturing sites. ↩︎