Elevar Gets Third CRL for Rivoceranib in HCC

The FDA issued a third Complete Response Letter to Elevar Therapeutics on July 10, 2026, blocking approval of rivoceranib plus camrelizumab as first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC). The rejection cited deficiencies from a cGMP inspection of a manufacturing site. No concerns were raised about clinical efficacy or safety.

Elevar is a majority-owned subsidiary of HLB Co., Ltd., which trades on the Korean exchange. The combination is not US-listed, so there is no direct stock ticker to track. The drug is already approved in China for first-line HCC under the brand names Aitan (rivoceranib) and AiRuiKa (camrelizumab), both developed by Hengrui Pharma.

What the data showed

The NDA was based on the global Phase 3 CARES-310 trial (NCT03764293), in which the combination achieved a median overall survival of 23.8 months versus 15.2 months for sorafenib. That is the longest overall survival reported to date among first-line HCC regimens. Treatment-related adverse events leading to discontinuation occurred in 17.6% of patients for camrelizumab and 16.9% for rivoceranib, with 4.4% discontinuing both. Grade 3 or higher toxicities were dominated by hypertension and transaminase elevations.

Rivoceranib is an oral tyrosine kinase inhibitor targeting VEGFR, a primary pathway for tumor angiogenesis (the formation of new blood vessels that feed tumors). Camrelizumab is a humanized anti-PD-1 antibody that releases the immune system’s brakes on T-cells, the same checkpoint inhibitor class as Merck’s Keytruda and Bristol Myers Squibb’s Opdivo. The combination attacks the tumor through two mechanisms: cutting its blood supply while simultaneously reactivating immune recognition. Camrelizumab has been studied in over 5,000 patients and is approved for eight indications in China.

The science worked. The factory did not pass inspection. All three CRLs for this combination related to manufacturing and cGMP deficiencies, not clinical data.

Why this matters

Three CRLs for the same drug in the same indication is a stark warning about manufacturing risk in biotech investing. CMC (chemistry, manufacturing, and controls) failures can kill an otherwise approvable drug regardless of how strong the clinical data is. Elevar is reviewing the letter and plans to work with the FDA on a path forward, but repeated manufacturing rejections suggest a deeper quality systems problem rather than a one-off inspection finding.

The competitive window is also closing. Standard of care in first-line HCC includes atezolizumab plus bevacizumab (Genentech/Roche), nivolumab plus ipilimumab (Bristol Myers Squibb), and durvalumab plus tremelimumab (AstraZeneca). Even if Elevar resolves the manufacturing issues on a fourth attempt, the combination would enter a crowded market years behind entrenched checkpoint inhibitor regimens. For more on what a CRL means and why manufacturing failures can kill an approvable drug, see our CRL guide.

What to watch next

Watch for Elevar’s response plan and whether a fourth resubmission is feasible. The longer-term risk is that the manufacturing site never passes inspection, which would effectively end the US approval path regardless of clinical merit. The combination remains approved and marketed in China, where Hengrui Pharma continues to generate revenue.

Elevar press release | OncLive coverage