With an FDA decision just weeks away, HLB has scored a major win in Europe. The Kosdaq-listed anticancer drug developer’s liver cancer drug, a combination of rivoceranib and camrelizumab (branded as “CAM-RIVO”), has been added to the European Society for Medical Oncology’s (ESMO) latest guidelines as a first-line treatment for hepatocellular carcinoma (HCC). 

The endorsement, issued last Thursday, comes just ahead of the FDA’s March 20 deadline for a final decision on the drug’s approval. HLB, which has already seen CAM-RIVO approved in China, is now riding the momentum of this European endorsement. “ESMO guidelines rarely back treatments that haven’t secured regulatory clearance,” said an HLB official, noting the rarity of such a recommendation. 

The revised ESMO guidelines, the first update since 2022, places CAM-RIVO among the top first-line treatments for liver cancer, backing it with a “very strong” clinical evidence rating (Level I). According to an HLB official, CAM-RIVO, with a median overall survival (mOS) of 23.8 months, has delivered the "longest survival data of any liver cancer therapy to date." The combination therapy pairs rivoceranib, an anti-angiogenic VEGFR-TKI, with camrelizumab, a PD-1 checkpoint inhibitor.

In 2023, HLB submitted a new drug application for CAM-RIVO as a first-line treatment for liver cancer, partnering with China’s Jiangsu Hengrui Pharmaceuticals. Despite high hopes that it could become the first domestically developed cancer drug to gain FDA approval, the agency issued a complete response letter, demanding more data and stalling the approval process. Now under priority review, the FDA’s March decision will be critical for CAM-RIVO’s U.S. prospects.

While other front-line therapies—like the bevacizumab + atezolizumab and durvalumab + tremelimumab combo—are also recommended for liver cancer, they come with added requirements, such as pre-screening for gastrointestinal bleeding risks. CAM-RIVO offers an alternative: it avoids the GI bleeding screening, positioning it as an attractive option for physicians wary of the more burdensome treatments.

As liver cancer remains the sixth most common cancer worldwide, with over 900,000 new cases annually, this development could shift treatment paradigms. HCC, accounting for 80 percent of liver cancer cases, is on the rise in Europe and North America, creating a pressing need for new, safer first-line therapies. HLB is betting that CAM-RIVO’s strong clinical data and European backing will push the drug to the forefront of treatment options, provided the FDA gives it the green light.

“This strong recommendation from ESMO signals that CAM-RIVO is already being recognized as an international standard for liver cancer treatment,” said Han Yong-hae, CEO of HLB Life Science and chief technology officer (CTO) of HLB Group. “It’s an encouraging sign for upcoming regulatory decisions in both the U.S. and Europe.”

HLB’s stock jumped nearly 10 percent following the announcement of the ESMO endorsement this morning,  closing at 92,500 won, up 9.34 percent. The company briefly hit an intraday high of 97,600 won, a 15.37 percent surge. Other HLB-affiliated companies also saw notable gains: HLB Pharmaceutical soared 17.29 percent to 31,550 won, while HLB Global, HLB BioStep, HLB Science, HLB Life Science, HLB Innovation, HLB Therapeutics, and HLB Panagene all posted solid increases.