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The line of shareholders at HLB’s annual meeting in Daejeon stretched past the registration table and out the door. Some had flown in. Others had held their shares for nearly a decade. They came with questions—many of them pointed, some desperate—but all circling the same issue: Why had the company’s long-awaited liver cancer drug been rejected twice by the FDA? And why should they still believe?
Chairman Jin Yang-gon took the floor for nearly two hours on Monday. His tone veered between technical and emotional, as he tried to steady the crowd with a mix of clinical detail, personal conviction, and blunt honesty. “It’s not over until it’s over,” he said, quoting the late baseball legend Yogi Berra. Then, after a beat: “I’m dying to know myself.”
The drug in question, a liver cancer combo known as CAM-RIVO—a combination of HLB’s VEGFR inhibitor rivoceranib and its subsidiary Elevar Therapeutics’ PD-1 inhibitor camrelizumab—was rejected for the second time this March.
The first complete response letter (CRL) flagged sterility concerns at Jiangsu Hengrui Pharmaceuticals’ multipurpose manufacturing plant. The second, Jin explained, came with softer language but a similar undertone: potential cross-contamination risks. "A different flavor of the same issue," he said.
That ambiguity has left the company—and its shareholders—adrift. “We don’t know what the problem is yet,” Jin admitted. “And that’s what’s driving us crazy.”
HLB Chairman Jin Yang-gon speaks at the company’s 40th annual shareholders meeting on Monday at Daejeon Convention Center, where roughly 200 shareholders gathered to press for answers following the FDA’s second rejection of the company’s liver cancer drug. (Credit: HLB)
HLB Chairman Jin Yang-gon speaks at the company’s 40th annual shareholders meeting on Monday at Daejeon Convention Center, where roughly 200 shareholders gathered to press for answers following the FDA’s second rejection of the company’s liver cancer drug. (Credit: HLB)
Still, Jin returned to one theme throughout: that this isn’t over. Not just the regulatory process, but the company’s broader vision. “Every roadmap was built around a March approval,” he said, referencing a cascade of upcoming indications: stomach cancer by June, liver cancer in July, bile duct cancer by December. “It’s painful to see that schedule slip.”
According to Jin, HLB has already completed a series of cleanroom simulations to address FDA’s manufacturing concerns. “Hengrui ran three separate processes to prove no residual contamination,” he said. “We thought we were done.” That optimism, echoed in last year’s shareholder meeting, made the second rejection all more jarring.
Korea Biomedical Review tallied 11 apologies, 12 mentions of “speculation,” seven of “trust” during the meeting. One word, though, edged out the rest: success—13 times, always in the future tense.
That tone didn't land evenly across the room.
One shareholder, a CMC expert working at a biotech firm, challenged Jin directly: “Even if you’ve done the validation runs, how can you be sure the FDA will accept it? From what I’ve seen, you can’t clean your way to compliance.”
Jin didn’t flinch. “That’s a valid concern,” he replied. “But the people at Hengrui know what they’re doing. They’ve been manufacturing rivoceranib for a decade. It’s still running today, and not because anyone’s cutting corners.”
Another shareholder pushed harder, questioning whether HLB should have filed for FDA approval before securing other country-specific green lights. Jin conceded the point. “That’s my biggest regret,” he said. “Had we filed in Taiwan or Korea first, we might’ve been on the market by now. But we put everything into the FDA.”
He paused. “And now we wait.” Then added, almost under his breath: “That waiting period is like hell for me.”
That wait may not be long. Jin expects a post-action letter from the FDA—a formal follow-up detailing what must be fixed—to arrive within the next week. If the issues are minor, HLB could resubmit its application by the end of May, with an approval possible as early as July.
“Look, if we had made a mistake in the data or had a safety issue, that would be different,” Jin said. “But we didn’t. This isn’t about science. It’s about the process.”
That process includes a growing list of near-term targets. Topline phase 3 data from HLB Therapeutics is due this quarter. Verismo, HLB’s U.S. CAR-T subsidiary, will report mid-phase 1 results by December. And by year-end, HLB company plans to submit a new drug application (NDA) for bile duct cancer drug lirafugratinib, already granted breakthrough therapy designation by the FDA.
In the meantime, Jin pushed back against the idea that the company was spinning distractions, including recent announcements about new indications and new manufacturing plans. “We’re not pivoting,” he said. “We’re expanding. That’s what a real pharma company does.”
Still, the crowd wasn’t buying everything.
One shareholder pressed Jin on whether the missing FDA inspection summary hinted at deeper trouble. Jin pushed back: “That’s a common misconception. You don’t need it before approval—it often comes after.”
Another wanted to know why Jin had bought shares in affiliates, not in HLB itself. “It’s because I couldn’t afford the optics,” he said. “Buying HLB stock before approval would’ve raised too many questions. But I wanted to show commitment.”
By the end of the meeting, one thing was clear: Jin isn’t going anywhere. “Until this drug is approved, I won’t sell a single share,” he said.
Meanwhile, the formal shareholder meeting itself was brief, lasting under 20 minutes. Four resolutions were passed unanimously, including 2024 financial statements, board appointments, and renewing a 5 billion won ($3.4 million) director compensation ceiling. The company paid just over 1.1 billion won last year.
One proposal—to revise executive severance policy—was withdrawn. Jin cited ongoing FDA uncertainty: “This isn’t the right time.” The plan would have awarded up to three months’ salary per year of service to top execs, including special payouts for injury, death, or exceptional contributions.
Newly appointed board members include Han Yong-hae, a former R&D lead at Daewoong Pharmaceutical and Enzychem Lifesciences, and Yang Chung-mo, a law professor and former regional commissioner.
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Kim Ji-hye jkim404@docdocdoc.co.kr
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