HLB and Hengrui's liver cancer combo gets a fourth FDA review, with a decision due April 9, 2027

The FDA has accepted the resubmitted applications for rivoceranib plus camrelizumab in first-line liver cancer. The clinical case was never the problem; the real test is whether a China-made PD-1 can clear US manufacturing inspections.

2026-11-04

The FDA has accepted the resubmitted applications for rivoceranib plus camrelizumab (CAM-RIVO) as first-line treatment for unresectable hepatocellular carcinoma, with an April 9, 2027 target date. Efficacy has never been the sticking point. This review is really a test of whether a Chinese-manufactured PD-1 antibody can pass US inspections, and the answer matters for every China-sourced biologic now sitting in a US licensing deal.

What happened

Korean biotech HLB (KOSDAQ: 028300) said on November 4 that the FDA has accepted the resubmitted new drug application (NDA) for rivoceranib and the biologics license application (BLA) for camrelizumab. The two will be reviewed together. The FDA classed the resubmission as Class 2, which comes with a six-month review clock and a goal date of April 9, 2027.

The applicants are Elevar Therapeutics, HLB's US subsidiary, which holds rivoceranib (an oral VEGFR-2 tyrosine kinase inhibitor), and Jiangsu Hengrui Pharmaceuticals (SSE: 600276; HKEX: 1276), which makes camrelizumab, its anti-PD-1 antibody. Both companies resubmitted on October 9, after the FDA issued a complete response letter (CRL) in July on the application filed in January 2026. HLB says manufacturing site inspections have since been completed. According to the company, a chemistry, manufacturing and controls (CMC) inspection is now the only step left.

Four filings, one trial

All four filings rest on the same dataset. In the global phase 3 CARES-310 trial, CAM-RIVO reached a median overall survival of 23.8 months, compared with 15.2 months on sorafenib (HR 0.64; 95% CI 0.52–0.79). The final analysis appeared in The Lancet Oncology in December 2025. The regimen is already listed as a first-line option in the 2025 BCLC strategy and in ESMO guidelines, even though no US approval exists yet.

The regulatory history looks like this:

May 2024: First CRL. It cited good manufacturing practice deficiencies at Hengrui's camrelizumab plant and incomplete clinical-site inspections. The FDA did not question efficacy or safety.
2025: Second CRL after resubmission. The reasons were not fully disclosed.
January 2026: Third submission. A CRL followed in July.
October 2026: Fourth submission, now accepted.

Our read is that this is no longer a question about liver cancer data. The repeated letters all point to the same weak spot: the US regulator is not yet satisfied with the camrelizumab supply chain. Every CRL has cost HLB about a year, and the commercial window has narrowed with each one. Roche's atezolizumab plus bevacizumab, AstraZeneca's durvalumab plus tremelimumab, and nivolumab plus ipilimumab are all established first-line choices in the US. A fourth entrant in 2027 will have to compete on its oral TKI convenience and its survival curve. It will not get a first-mover premium.

Why this matters beyond HLB

For Asian biotech, CAM-RIVO has become a test case for something bigger than one drug. Western pharma has been paying record sums to license Chinese assets, and almost all of them are still in the clinic. Few of those deals have yet had to show that a Chinese commercial biologics plant can survive a pre-license inspection by the FDA. If camrelizumab gets through, it gives buyers a reference point that Chinese CMC can clear the bar for a first-line US label. If it fails a fourth time, expect licensees to push even harder for US or EU manufacturing transfers, along with tech-transfer milestones, in new China deals.

For Hengrui, which reported steady nine-month growth this year and has become one of China's most active out-licensors, a US approval of its own PD-1 antibody would put a Hengrui-made biologic on the US market under its own name. That would strengthen its position in future partnering talks.

For HLB's shareholders, the stock has swung sharply on every FDA milestone since 2024. A Class 2 acceptance with a firm date is the cleanest setup the company has had. Still, the risk sits in a factory inspection, not in a statistic.

For more on Asian oncology small molecules, see our oncology small-molecule track and the Asia tracks overview.

What to watch

When the FDA schedules the camrelizumab CMC inspection, and whether HLB or Hengrui discloses Form 483 observations.
Any update on the April 9, 2027 date. A major amendment would extend the clock by three months.
Whether Hengrui and HLB disclose the start of label negotiations ahead of the goal date.
How new US–China licensing deals word their manufacturing-transfer clauses while this review is pending.

Sources

This article is industry and company analysis, not investment or medical advice.