[Madrid, Spain = E-Daily Reporter Kim Jinsoo ] “We plan to finalize the U.S. launch price for Rifictu (Lirapugratinib) by the end of this year. We are consulting with key stakeholders, including insurers and pharmacy benefit managers (PBMs), regarding pricing and insurance coverage, and are working to ensure the drug is included on the list of medications covered by insurance.”

Kim Dong-geon, CEO of Elevate Therapeutics, told PharmDaily on the 26th at the European Society for Medical Oncology (ESMO) conference in Madrid, Spain, “We are targeting the start of product supply in December of this year for the U.S. commercialization of Ripictu, and we expect revenue to begin by the end of this year or early next year.”

HLB INC.(028300) Ripicto, a bile duct cancer treatment developed by subsidiary Eleva Therapeutics, received approval from the U.S. Food and Drug Administration (FDA) on September 23. The approval applies to adult patients with previously treated, unresectable, locally advanced, or metastatic bile duct cancer who have been confirmed to have an FGFR2 gene fusion or rearrangement.

Following Ripictu’s FDA approval, healthcare professionals have been responding positively at the European Society for Medical Oncology (ESMO 2026) conference, which served as the drug’s global debut. CEO Kim said, “Healthcare professionals showed great interest and a positive attitude, recognizing that patients now have a new treatment option.”

Ripictu Aims for ‘Premium’ Status Based on Advantages Over Competitors

With an estimated 600 patients eligible to receive Ripictu in the U.S.

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the most critical factors for commercialization are expected to be “drug pricing,” “insurance coverage,” and “securing a prescription base.”

CEO Kim said, “We have already completed the establishment of a distribution network to ensure rapid supply following the product launch,” adding, “We are making comprehensive preparations to ensure patients have broad and timely access from the moment commercial supply begins.”

Eleva is using the prices of existing FGFR inhibitors, such as femigatinib and futibatinib, as a reference. CEO Kim explained, “Based on the data we have gathered, I do not believe that Ripictu’s price must necessarily be lower than that of competing products,” adding, “Rather, we plan to price it as a premium product.”

In its pivotal clinical trial, Ripictu achieved an objective response rate of 46% and a median duration of response of 11.8 months. While not an exact comparison, based solely on these figures, these results surpass those of existing FGFR-targeted therapies such as Pemazyr (36%, 9.1 months) and Ritgovi (42%, 9.7 months).

Efforts to secure insurance coverage are also underway. Repicto has received a Category 2A recommendation in the National Comprehensive Cancer Network (NCCN) guidelines for biliary tract cancer. CEO Kim believes this recommendation will aid healthcare professionals in prescribing the drug and facilitate discussions regarding insurance reimbursement.

He stated, “Even after listing with prescription drug reimbursement management agencies, ongoing discussions will be necessary regarding drug pricing, reimbursement negotiations, and supply chain establishment,” adding, “We are preparing our sales strategy by retaining key personnel in-house while utilizing external specialized firms, such as Contract Sales Organizations (CSOs).”

Regarding sales and market share, CEO Kim said, “The drug price has not yet been finalized, and we are reevaluating market share with external specialists. I believe we will be able to set concrete sales targets once all of this work is completed.”

Sales of Femigatinib and Futibatinib—competitors to Repicto—are projected to reach approximately $145 million (about 191.8 billion won) in 2025. Eleva plans to secure market share in the existing market and expand the patient population eligible for treatment by expanding molecular diagnostic testing.

In particular, Eleva plans to rapidly capture market share by providing education to healthcare professionals in the U.S. Since cancer treatment in the U.S. takes place not only at large hospitals but also at community healthcare facilities, the company’s strategy is to increase prescriptions by educating primary care physicians on prescribing guidelines and methods for managing adverse reactions.

Approval Expected in Europe Next Year… Estimated Patient Population of About 500

Following its U.S. launch, the company is also accelerating preparations for its entry into the European market. On the 14th of last month, Eleva submitted a Marketing Authorization Application (MAA) for lirapugratinib to the European Medicines Agency (EMA). The company is exploring options to secure a sublicensing partner for local commercialization.

CEO Kim stated, “We expect a decision on approval to be made sometime next year,” adding, “It is difficult to pinpoint an exact timeline because we do not yet know what additional data the EMA may request, and it will take time to prepare that data.”

According to Eleva’s analysis, there are approximately 500 patients in the four major European countries (EU4) and the United Kingdom who are eligible for second-line treatment of FGFR2 fusion or rearrangement-positive cholangiocarcinoma. This suggests that a market of a similar scale to that in the United States could be established. Since the reimbursement environment in each country affects access to molecular diagnostic testing, the number of patients who can actually be treated is a key factor in market expansion.

Finally, he stated, “While actual sales levels will vary depending on the approved regions, the scope of indications, and market entry conditions, I believe we can expect significant sales if we secure approvals in various regions, including Europe, and achieve the initially targeted expansion of indications.”