FDA sets 9 April 2027 decision date for HLB liver cancer drug under Class 2 review

A Class 1 classification would have allowed a decision around 9 December, two months after the 9 October resubmission. Class 2 sets the target about four months later, extending regulatory risk for investors and pushing back any US launch of the liver cancer combination.

A six-month clock instead of two

Elevar Therapeutics and its Chinese partner Hengrui Pharma refiled on 9 October 2026. The FDA classified the resubmission as Class 2, a category that carries a six-month review. HLB shares fell 19.90%, or 8,100 won, to 32,600 won in early trading on 4 November.

Selling spread across the group. HLB BioStep fell 21.46%, HLB Pharmaceutical 19.94% and HLB Life Science 16.27%.

Volume reached more than 176% of the prior day's full-day total as sell orders piled in after the open. Some in the industry had expected a Class 1 tag after the manufacturing fixes, Chosunbiz reported.

What the company had expected

A Class 1 resubmission covers relatively limited amendments and takes about two months. Vice Chairman Kim Tae-han told an investor day in Yeouido, Seoul, on 15 October that he believed the likelihood of Class 1 was very high and that approval could come as early as this year. Chairman Jin Yang-gon used the same event to call the attempt "truly the last challenge".

The FDA approved Lyrfigtu, HLB's bile duct cancer drug, on 23 September 2026, the group's first US approval.

Three rejections, one manufacturing thread

The combination was first filed in May 2023 and has drawn three complete response letters, in May 2024, March 2025 and on 9 July 2026. The first two centred on pre-approval inspection issues at Hengrui Pharma's camrelizumab production site in China. The third came after problems surfaced at a separate Hengrui facility making the rivoceranib drug substance, a plant that already exports generics to the United States.

The rivoceranib active ingredient plant drew a Voluntary Action Indicated classification in July, and the finished-drug plant the same in early October. VAI means inspectors found deficiencies but judged the company able to correct them without formal regulatory action.

HLB told investors in October that the chemistry, manufacturing and controls problems behind the three rejections had been resolved, leaving clinical data to be judged on its merits. From the first filing in May 2023 to the April 2027 target date is about three years and 11 months.

The clinical file the FDA will weigh

The application rests on CARES-310, a global Phase 3 trial in unresectable or metastatic hepatocellular carcinoma. Median overall survival was 23.8 months for the rivoceranib plus camrelizumab arm against 15.2 months for sorafenib, a gap of 8.6 months and a 36% reduction in the risk of death. The company reported a hazard ratio of 0.64, with a 95% confidence interval of 0.52 to 0.79 and a P value below 0.0001.

Final results were published in The Lancet Oncology in December 2025. HLB said the combination also appeared in 2025 Barcelona Clinic Liver Cancer and European Society for Medical Oncology guidance as a first-line option, before any regulator had approved it. The company says the reviews so far have produced no separate requests for more data on the combination's efficacy or safety.

Kim Dong-gun, chief executive of Elevar Therapeutics, said unresectable liver cancer remains an area of high unmet need and the company had worked to give patients and clinicians a new option. With the manufacturing facility inspections concluded, he said Elevar would work closely with the FDA to ensure the review concludes successfully, based on the clinical value confirmed in the global Phase 3 trial.

What happens next

The FDA will review the drug application and Hengrui Pharma's biologics license application for camrelizumab together. A Class 2 classification does not by itself mean new deficiencies were found or that approval will fail. It remains unclear how far the FDA will examine the resubmission materials.

Lyrfigtu is being prepared for a US launch in the fourth quarter of 2026, with Europe and other markets to follow. Cholangiocarcinoma and liver cancer treatments are prescribed mainly by the same gastrointestinal cancer specialists, and Financial News reported that the US sales network built for the Lyrfigtu launch is expected to be used for the liver cancer drug if it is approved.