HLB’s liver cancer drug prospects improve after FDA approval

Korean drug developer HLB is advancing its efforts to launch a liver cancer treatment, following its inaugural US Food and Drug Administration approval for a cancer drug.

On September 23, the FDA approved Lyrfigtu, developed by HLB’s US subsidiary Elevar Therapeutics, for patients with previously treated advanced bile duct cancer.

First approval boosts confidence

This achievement has provided Elevar and HLB with valuable insights into the FDA approval process, enhancing confidence in their US drug-development capabilities.

Following the approval, HLB shares surged 30%, reaching a daily high on September 28. A representative from a Korean pharmaceutical company noted that this experience could improve Elevar’s management of future regulatory submissions.

Rivoceranib’s regulatory setbacks

HLB is now concentrating on rivoceranib, an oral targeted therapy for liver cancer, developed in collaboration with Chinese partner Jiangsu Hengrui Pharmaceuticals. Despite promising clinical data, rivoceranib has faced three FDA rejections.

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The most recent rejection in July was attributed to deficiencies found during an inspection of a manufacturing facility. However, recent inspections at two facilities associated with rivoceranib have alleviated concerns, with the FDA classifying them as Voluntary Action Indicated (VAI).

The VAI classification signifies that inspectors identified issues but did not recommend formal regulatory action, removing a significant barrier to HLB’s resubmission of its new drug application for rivoceranib.

Future prospects

HLB’s chairman, Jin Yang-gon, emphasized the Lyrfigtu approval as a significant milestone in the company’s globalization efforts. He stated that HLB will continue to deliver advancements, including treatments for liver cancer, keratitis, and CAR-T therapies.

HLB’s experience with the FDA approval process and its collaboration with Jiangsu Hengrui are expected to contribute to its future efforts to advance rivoceranib and other therapies.