[Edaily Reporter KIM SAE-MI ] “In my desk drawer, there are three YouTube scripts piled up announcing that new anticancer drugs developed by HLB INC. have received official approval from the FDA. Of course, I never got to read any of them. I am extremely pleased that I am now able to read the fourth script I prepared, and at the same time, I am filled with mixed emotions.”

Jin Yang-gon, Chairman of the Board of HLB INC., shared these reflections on the 24th via the company’s official YouTube channel regarding the U.S. Food and Drug Administration’s (FDA) approval of the new drug. HLB INC.(028300), which had faced three setbacks with its liver cancer drug, has finally achieved its first FDA approval with “Lirapugratinib,” a new treatment for cholangiocarcinoma.

On the 23rd (local time), HLB INC.’s U.S. subsidiary, Eleva Therapeutics, received FDA approval for “Lyfictu” (LYRFIGTU, generic name: lirapugratinib) as a second-line treatment for patients with cholangiocarcinoma harboring FGFR2 fusions or other rearrangements. This marks the fruition of the “global anti-cancer drug” strategy that Jin Yang-gon, Chairman of the HLB INC. Board of Directors, has been pursuing for a long time, culminating in the company’s “first FDA approval.”

HLB INC. had been striving to obtain FDA approval for a combination therapy of Riboceranib and Kamrelizumab—an immunotherapy developed by China’s Henan Pharmaceutical—as a first-line treatment for liver cancer. However, the approval process was halted three times. HLB INC. maintains that the delays were not due to issues with the efficacy or safety of Riboceranib itself, but rather to manufacturing and quality control (CMC) issues at its partner, Hengrui Pharmaceuticals.

HLB’s quest for FDA approval of Riboceranib continues. Chairman Jin stated, “Approval was delayed due to Hengrui’s CMC issues, but the required corrections have already been completed,” adding, “We are currently moving forward with this work at a rapid pace and will resubmit the application as soon as it is finalized.”

While Riboceranib’s approval process has been prolonged, HLB INC. secured another asset: Lirapugratinib. Unlike the extensive time and effort invested in the global development of Riboceranib, the company adopted a strategy this time to rapidly advance a late-stage drug candidate—whose clinical development had already progressed significantly—acquired from an external source, toward approval and commercialization.

In December 2024, Eleva secured exclusive global development and commercialization rights for Lirapugratinib from Relay Therapeutics in the U.S. The deal is valued at up to $500 million (approximately 684 billion won). The deal consists of an upfront payment and regulatory milestones totaling up to $75 million (103 billion won), as well as commercialization milestones totaling up to $425 million (581 billion won). Since signing the agreement, Eleva has been solely responsible for further development and global commercialization.

This led to FDA approval approximately one year and nine months after securing the rights. With Ripictu clearing the FDA hurdle, HLB INC. has achieved its first tangible success in its strategy to expand its anticancer drug business—which had previously been concentrated on Riboceranib—into a multi-product pipeline.

Chairman Jin did not view the significance of this approval as merely securing a single new drug. He pointed out, “Obtaining approval for a new drug requires submitting clinical data spanning over 10 years, understanding regulatory and administrative procedures, and communicating with the FDA,” adding, “HLB INC. has gone through this process multiple times.” He continued, “In particular, through the process of addressing requests for additional data in the CMC (Chemistry, Manufacturing, and Controls) sector, we have accumulated experience and capabilities on par with those of global big pharma companies,” adding, “This accumulated experience and capability have become assets just as valuable as the drug approval itself.”

The next goals are commercialization and the expansion of indications. HLB is accelerating the launch of Ripictu in the U.S. market while simultaneously pursuing entry into the European market. Eleva submitted a marketing authorization application for lirapugratinib to the European Medicines Agency (EMA) on the 15th. HLB is also conducting global clinical trials to broaden Ripictu’s scope of use as an anticancer drug effective against all types of cancer.

Chairman Jin remarked, “We have the manuals and organizational structure in place that we prepared in anticipation of the approval of this new liver cancer drug, so a rapid launch will be possible,” adding, “We will accelerate the expansion of Ripictu’s indications and use this new drug as a springboard to begin collaborations with big pharma.”

In particular, Chairman Jin reiterated the company’s existing strategy of completing new drug development and commercialization in-house rather than relying on technology exports. He emphasized, “I believe it is more progressive to secure an anticancer drug on our own and propose, ‘Shall we develop our anticancer drug in combination with yours?’ rather than entrusting the company’s fate to a big pharma’s actions after exporting technology and asking them to ‘please develop our new drug well.’”

Meanwhile, Chairman Jin also made a pointed statement regarding short selling that day. He claimed that HLB INC. had been under intense attack from short sellers for seven years since 2019, and appealed, “I earnestly ask financial regulatory authorities to thoroughly investigate the trading behavior of those executing short sell orders, at least from this point forward.”

HLB INC.’s nearly 20-year journey to develop a new anticancer drug has reached a milestone with the approval of Repicto. However, the “unread manuscript” still sitting in Chairman Jin’s desk drawer has not disappeared. This is because the task of securing FDA approval for Riboceranib remains.

Chairman Jin stated, “The approval of the new drug for cholangiocarcinoma is not the end, but the beginning.” All eyes are now on whether HLB INC., which first opened the door to the FDA with Ripictu, will achieve a series of successes, including commercialization in the U.S., approval in Europe, and a renewed attempt for Riboceranib.

◇ Profile of Jin Yang-gon, Chairman of the Board of HLB INC.
△Born in Busan Metropolitan City in 1966
△Graduated from Wonkwang University with a degree in Law in 1990
△ 1993: Master’s degree in Economics, Yonsei University Graduate School
△ Worked at Busan Bank from 1991 to 1994
△Worked at Pyeonghwa Bank from 1994 to 1998
△2004: CEO of Golden Light
△2006: Chairman of Hyundai Life Boat
△2008: Acquired HiCell and became Chairman
△2013: Acquired HLB INC.
△2017–2025: CEO of HLB INC.
△2025–Present: Chairman of the Board of Directors, HLB INC.