On September 23, 2026, the South Korean pharmaceutical company HLB reached a long-awaited milestone: its US subsidiary, Elevate Therapeutics, received approval from the US Food and Drug Administration (FDA) for Lyrfigtu (lirafugratinib), an oral drug designed to treat cholangiocarcinoma patients whose tumors have FGFR2 fusion or rearrangement. The announcement, made public on September 24, marks not only a breakthrough for HLB but also a significant first for the Korean pharmaceutical industry. According to Yonhap News, HLB is now the first Korean drugmaker to have directly submitted a New Drug Application (NDA) to the FDA and successfully obtained approval for an anticancer agent.
Cholangiocarcinoma, a rare and aggressive cancer that forms in the bile ducts, affects about 8,000 people in the United States each year. For patients with FGFR2 fusion or rearrangement, treatment options have historically been limited, making the FDA’s green light for Lyrfigtu a beacon of hope. HLB’s US launch of the drug is targeted for the fourth quarter of 2026, with plans to expand into Europe and explore additional uses for the drug in other solid tumors, as confirmed by the company’s official statements.
HLB Chairman Jin Yang-gon didn’t hide his emotions as he addressed the company’s journey. In a video posted to HLB’s official YouTube channel, Jin reflected, “There are three YouTube scripts in my desk drawer announcing the FDA approval of our anticancer drug, but I never got to read any of them. This time, I am very pleased to finally read the fourth script, and my feelings are mixed.” Jin’s words, reported by Edaily, capture the years of anticipation, setbacks, and relentless pursuit that led to this moment.
HLB’s path to this achievement was far from straightforward. The company had previously set its sights on FDA approval for lenvatinib, a liver cancer drug developed in combination with Camrelizumab, but ran into repeated roadblocks. According to Edaily and Yonhap News, the delays stemmed not from the efficacy or safety of lenvatinib itself, but from manufacturing and quality control issues tied to HLB’s Chinese partner, Antengene. Jin clarified, “The approval was delayed due to Antengene’s CMC [chemistry, manufacturing, and controls] problems, but the required improvements are now complete. We are working quickly to finish the process and will reapply as soon as possible.”
While the lenvatinib saga continued, HLB pivoted to a new strategy: securing late-stage drug candidates from external partners to accelerate the path to approval and commercialization. In December 2024, Elevate Therapeutics obtained exclusive global development and commercialization rights for lirafugratinib from Relay Therapeutics, in a deal worth up to $500 million. The agreement included up to $75 million in approval-related milestones and up to $425 million for commercialization milestones. Just one year and nine months later, this bold move bore fruit with the FDA’s nod for Lyrfigtu.
Lyrfigtu stands out among FGFR inhibitors for its selective binding to FGFR2, a feature that could offer improved efficacy and safety for patients. HLB’s clinical trials demonstrated the drug’s safety and effectiveness in patients with FGFR2 fusion or rearrangement cholangiocarcinoma, providing a much-needed new treatment option. The company is now working on expanding Lyrfigtu’s reach, having already submitted an application to the European Medicines Agency (EMA) and launched additional trials for other solid tumors with similar genetic profiles.
Jin Yang-gon underscored the significance of the FDA approval, framing it as more than just a commercial win. “To obtain new drug approval, you must submit clinical data collected over more than ten years, understand regulatory and administrative procedures, and communicate with the FDA,” he noted. “HLB has experienced this process several times. Especially in the CMC area, we gained experience and capabilities at the level of global big pharma. This accumulated experience and capability have become a great asset, no less valuable than the drug approval itself.”
Patent protection for Lyrfigtu extends until 2040, giving HLB a lengthy runway to establish the drug in global markets. Jin emphasized the company’s commitment to independent development and commercialization, stating, “Our goal was to complete new drug development on our own, without technology transfer.” He added, “Rather than exporting technology and leaving our fate in the hands of big pharma, I believe it’s more productive to secure our own anticancer drugs and then propose combination development with other companies’ drugs.”
The company’s ambitions don’t stop at Lyrfigtu. HLB is preparing to resubmit its FDA application for lenvatinib, having addressed the manufacturing and quality control issues that previously held up approval. Jin explained, “For the FDA resubmission, we will provide the latest safety information from clinical trials and additional safety data obtained from overseas trials up until the resubmission date. We are currently working on this, and as soon as we finish, we will resubmit.”
Looking ahead, HLB has a full pipeline. The company plans to unveil Phase 3 clinical trial results for a corneal inflammation drug by the end of the year, and its US subsidiary Berismo is set to announce clinical results for a CAR-T therapy targeting blood cancer. HLB’s leadership sees the approval of Lyrfigtu as just the beginning of a broader expansion, aiming to accelerate follow-up drug approvals and diversify its portfolio.
Jin also took the opportunity to address the financial pressures HLB has faced, particularly from short-selling. He claimed that since 2019, HLB has been the target of concentrated short-selling attacks. “I earnestly ask financial supervisory authorities to thoroughly examine the trading behavior of those executing short-selling orders from now on,” he said, appealing for regulatory scrutiny.
Industry observers note that HLB’s FDA approval is a watershed moment for Korean biotech, demonstrating that homegrown companies can navigate the world’s toughest regulatory environments and bring innovative therapies to market. HLB’s approach—combining persistence, strategic licensing, and an insistence on independent commercialization—may serve as a model for other Asian pharmaceutical firms hoping to break into the global oncology market.
Still, challenges remain. The company’s long-term success will depend on how quickly it can launch Lyrfigtu in the US, secure approvals in other markets, and resolve outstanding regulatory hurdles for its other drug candidates. For now, though, the mood at HLB is one of celebration and cautious optimism, with Jin’s long-held scripts finally seeing the light of day—and new chapters still to be written.