HLB Group Chair Jin Yang-gon said he expects the U.S. Food and Drug Administration (FDA) to grant marketing approval this year for new drugs for liver cancer and cholangiocarcinoma.
At the HLB Forum held on the 12th at the Sofitel Ambassador Seoul Hotel in Songpa-gu, Seoul, Jin said, "If we obtain approval for the new drug, it will be the first success case in 20 years since we began developing anticancer drugs."
HLB's lead pipelines now seeking FDA approval are the liver cancer treatment "Rivoceranib" and the cholangiocarcinoma treatment "lirafugratinib."
Rivoceranib is a targeted anticancer drug under development by HLB's U.S. subsidiary Elevar Therapeutics, and it is under FDA review in combination with Camrelizumab, an immune checkpoint inhibitor from China's Hengrui Pharma. After two complete response letters in 2023 and 2024, the company resubmitted its application in January this year reflecting the FDA's requests for additional information. A decision is expected by July.
The candidate cholangiocarcinoma treatment lirafugratinib was granted FDA priority review in March. Accelerated approval review is underway based on phase 2 results, with a decision expected in September.
As a next-generation core pipeline, Jin also mentioned SynKIR-110, a chimeric antigen receptor T cell (CAR-T) therapy from Verismo Therapeutics, a U.S. subsidiary of HLB Innovation. The therapy is in a phase 1 trial for solid and hematologic cancers.
Jin said, "Verismo's CAR-T Therapy targeting solid tumors is showing encouraging interim clinical results," adding, "The global phase 3 trial of the keratitis treatment that HLB Therapeutics has been developing for 11 years is also in its final stage."
HLB Therapeutics is set to announce next month the global phase 3 results of RGN-259, a treatment for neurotrophic keratopathy (NK) in the ophthalmology field.
He added, "The current progress is not just advancement of individual pipelines but a flow leading to commercialization, indication expansion, and next-generation platforms," emphasizing, "This will be the starting point for HLB to leap into a global pharmaceutical company."