[Edaily Reporter Minji Son ] HLB Group celebrated the U.S. Food and Drug Administration (FDA) approval of “Ripictu” (generic name: lirapugratinib), a new drug for cholangiocarcinoma, and pledged to use this as a springboard for a new leap forward as a global pharmaceutical and biotech company.

HLB INC. announced that it held a ceremony on the 29th at its Hak-dong headquarters in Gangnam-gu, Seoul, to celebrate the FDA approval of Ripictu and share this achievement with employees who participated in the new drug’s development and approval process. The event was attended by HLB INC. Chairman Jin Yang-gon, key executives, and employees.

Ripicto is a treatment for cholangiocarcinoma developed by Eleva, HLB INC.’s U.S. subsidiary. HLB INC. explained that this approval marks the first instance in which a South Korean company has directly led the FDA approval process for a new anticancer drug and secured approval.

Eleva will begin commercializing Ripictu starting with its launch in the U.S. It also plans to pursue the European approval process. The company is also exploring ways to expand the patient population eligible for treatment through clinical trials across all cancer types and the development of combination therapies with other drugs.

Kim Dong-geon, CEO of Eleva, said in a video message, “This FDA approval not only provides new treatment opportunities for patients with cholangiocarcinoma but also serves as a milestone in our leap toward becoming a global pharmaceutical and biotech company.” He added, “As we move beyond new drug development and approval to directly commercialize the product in the U.S. market, we will accelerate our entry into the global market.”

HLB INC. has declared a “second founding” in light of this approval. The plan is to apply the capabilities accumulated during the development and approval process of Repicto to the group’s subsequent pipeline to generate sustained commercial success.

On this day, Jin Yang-gon, Chairman of HLB INC., presented “Connection, Challenge, Innovation, Attitude, and Responsibility” as the company’s five core values. “What we have achieved is not limited to a single new drug for cholangiocarcinoma; it is the fact that we have established the foundation and capabilities to continue delivering new drug successes in the future,” he said. “Starting with Ripicto, we will accelerate the development of our subsequent pipeline, including treatments for liver cancer, keratitis, and CAR-T therapies.”