[Edaily Reporter KIM SUNG-JIN ] Jin Yang-gon, Chairman of HLB Group, said on the afternoon of the 15th at the HLB Group investor relations event “HLB Group IR Day” held in Yeouido, “While we are currently maintaining our direct sales strategy, we may change our strategy if global big pharma companies propose not only sales but also the expansion of Riboceranib’s indications to various types of cancer.”

This is interpreted to mean that the company can flexibly adjust its U.S. market strategy for LYRFIGTU (lirapugratinib)—the first new anticancer drug in Korea to receive approval from the U.S. Food and Drug Administration (FDA)—depending on the situation. In other words, if a proposal from a global pharmaceutical company can create greater value than in-house development and commercialization, HLB is open to changing its collaboration model. HLB aims to launch Lyrfigtu in the U.S. in the fourth quarter of this year.

Pricing is also considered a key variable in LYRFIGTU’s U.S. commercialization strategy. HLB INC. stated that, based on a review of data on competing drugs, it believes LYRFIGTU is competitive and therefore expects to be able to set a higher price than its competitors.

Kim Hong-cheol, CEO of HLB INC., stated, “Based on our excellent data, we expect the price negotiated with insurance companies to be higher than what we previously received,” adding, “The current price of competing drugs is approximately 30,000 dollars per month, and we expect Ripictu to command a 15–20% premium over that.”

On the same day, Riboceranib, a new liver cancer drug considered one of HLB INC.’s next-generation drug candidates, also drew significant attention. HLB INC.’s U.S. subsidiary, Eleva Therapeutics, and China’s Hengrui Pharmaceuticals are resubmitting an application for FDA approval of the Riboceranib and Camrelizumab combination therapy.

Although Riboceranib is a liver cancer treatment that HLB INC. has been developing for 19 years, its approval has been delayed after the company received three Complete Response Letters (CRLs) from the FDA. HLB INC. emphasized that the manufacturing facility issues—which were the cause of the repeated approval failures—have now been resolved.

Kim Tae-han, Executive Chairman of the HLB INC. Bio Division—who moved from SAMSUNG BIOLOGICS to the HLB INC. in January of this year—stated, “Clinical data is the most important aspect of new drug development, and in that regard, it is flawless,” adding, “The issues that had been problematic in the manufacturing sector have also been resolved.”

He continued, “I expect to receive notification of the next review by November 9 at the latest,” adding, “If classified as Class 1, final approval could be granted within two months, and I consider the likelihood of a Class 1 classification to be very high.” Classes 1 and 2 refer to the categories used by the FDA to classify the review periods applied when a new drug application that has received a CRL is resubmitted. A Class 1 review takes one month, while a Class 2 review takes six months.

When asked about a contingency plan in the event the application is rejected by the FDA again, Chairman Jin replied, “While developing this new drug, we’ve prepared not just Plans B, C, and D, but all the way up to Plan Z,” adding, “Even if we receive another request for additional information, we’ll be well-prepared to resubmit the application.”

Chairman Jin remarked, “Although we’ve produced just one small flower in the process of securing approval for a new drug to treat bile duct cancer, what we’ve cultivated in the process is not just a single flower, but a tree capable of producing many flowers,” adding, “Based on the experience we’ve accumulated, I believe we will achieve results in our other pipeline projects as well.”