Korean drug developer eyes US approval for rivoceranib despite three setbacks
HLB’s first US approval for a cancer drug has given the Korean company fresh momentum in its effort to bring rivoceranib, a long-delayed liver cancer treatment, to market, as it seeks a green light from the US Food and Drug Administration after three failed attempts.
The FDA approved Lyrfigtu, developed by HLB’s US subsidiary Elevar Therapeutics, for patients with previously treated advanced bile duct cancer harboring FGFR2 fusions or rearrangements on Sept. 23.
The milestone gave Elevar Therapeutics and HLB firsthand experience navigating the FDA approval process, while recent inspections at two manufacturing facilities linked to rivoceranib have eased a major obstacle to another application.
Rivoceranib, an oral targeted therapy, is being developed with Chinese partner Jiangsu Hengrui Pharmaceuticals’ immunotherapy camrelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma, the most common form of liver cancer.
Although the combination achieved median overall survival of 23.8 months in a global phase 3 trial, promising clinical data have not been enough to pass the FDA’s regulatory review as HLB came up short three times in getting the green light for its liver cancer drug.
The latest rejection in July focused on deficiencies identified during an inspection of a manufacturing facility associated with rivoceranib. The FDA had raised manufacturing concerns involving camrelizumab in the earlier reviews, highlighting HLB’s reliance on its Chinese partner to meet US regulatory standards.
The outlook, however, has since improved. The FDA classified Hengrui’s active pharmaceutical ingredient manufacturing facility as Voluntary Action Indicated, or VAI, in July. Earlier this month, the finished-drug manufacturing facility also received the same classification.
The FDA’s VAI classification indicates that inspectors identified issues warranting voluntary corrective action but did not recommend formal regulatory action. The classifications remove a substantial source of uncertainty, although they do not guarantee approval or rule out further FDA questions.
“The VAI classification is the result of Jiangsu Hengrui Pharmaceuticals’ all-in efforts to remove the issues from the on-site inspection,” said an HLB official. “Elevar will soon finish the preparations for resubmitting the liver cancer drug’s (new drug application) in close cooperation with Jiangsu Hengrui Pharmaceuticals and thoroughly deal with the FDA’s review.”
Rivoceranib’s regulatory setbacks have repeatedly battered HLB shares. The stock plunged 30 percent to hit the daily low on the Kosdaq each time after the FDA rejections: first in May 2024, second in March 2025 and again in July this year.
But after Lyrfigtu’s approval became known, HLB shares surged 30 percent to reach the daily high on Sept. 28, reflecting renewed confidence in the company’s US drug-development capabilities.
“Elevar has now taken a cancer drug through the FDA application and review process to approval,” an official at a Korean pharmaceutical firm said.
“That experience could help the company manage regulatory submissions and respond to FDA requests more effectively in future applications… but it does not mean rivoceranib will receive the same treatment, as the two drugs have different targets, indications and regulatory dossiers.”
HLB held a celebratory event for the FDA approval of Lyrfigtu at the company’s office in Seoul last month, and HLB Group Chairman Jin Yang-gon highlighted the achievement as a turning point for the company’s globalization.
“What we accomplished is not just a single milestone with a bile duct cancer drug but the foundation and capability to continuously produce new drug successes in the future,” he said.
“Starting with Lyrfigtu, we will sequentially deliver more achievements, including treatments for liver cancer, keratitis, and CAR-T therapies, to prove the value of HLB Group in the global market.”
hwkan@heraldcorp.com