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Summary
- The FDA's final decision date (PDUFA Date) for the combination therapy of rivoceranib and camrelizumab is just about a month away, scheduled for July 23, 2026.
- This review marks the third attempt after receiving two Complete Response Letters (CRLs). Classified under "Class 2," the review is highly focused on specific supplemental items.
- On the stock price front, market debates regarding the method of Hengrui Medicine's inspection (on-site vs. paper-based) and the progress of the global clinical trials for follow-up cholangiocarcinoma pipelines are drawing close attention.
Current Situation Overview
As the review result for HLB's first-line treatment for liver cancer—widely considered one of the largest events in the domestic biotech industry—approaches, market attention is intensifying.
Under the Prescription Drug User Fee Act (PDUFA), the FDA is required to make a final approval decision on the rivoceranib combination therapy by July 23.
[Image: /stdaily/uploads/202606/gen_6a3a3d8fd863c4.38136870.png]
At the same time, the final NDA review result for "lirafugratinib," a cholangiocarcinoma treatment candidate pushed by its subsidiary Elevar Therapeutics, is scheduled to be decided by September 27, queuing up major events for the second half of the year.
Recently, on June 19, the first patient dosing was officially initiated in a global Phase 2 clinical trial of lirafugratinib aimed at tumor-agnostic indication expansion.
However, on June 23, 2026, the domestic stock market experienced a sharp decline due to heavy profit-taking.
The KOSPI plunged 9.99% to close at 8,203.84, while the KOSDAQ fell 7.94% to 891.52. HLB's stock price also closed at 47,700 won, down 6.10% from the previous day amid heightened market volatility.
| Pipeline | Indication & Specific Target | Milestone Stage | Expected Date & Recent Status |
|---|---|---|---|
| Rivoceranib + Camrelizumab | Unresectable hepatocellular carcinoma (1st-line) | FDA NDA/BLA Resubmission (PDUFA) | July 23, 2026 (Target date) |
| Lirafugratinib | FGFR2 fusion/rearrangement cholangiocarcinoma (2nd-line) | FDA NDA Review Result | September 27, 2026 (Target date) |
| Lirafugratinib | FGFR2 gene-mutated solid tumors (Tumor-agnostic) | Global Phase 2 Clinical Trial (ReFocus202) | First patient dosing initiated on June 19, 2026 |
Financial Analysis
HLB’s recent financial statements show high volatility due to non-operating valuation losses despite top-line growth.
Consolidated revenue for 2025 reached 83.9 billion won, up 23.17% year-on-year, and the operating loss narrowed by approximately 9.73% to 106.9 billion won.
Thanks to steady growth in the healthcare and composite materials divisions, core business profitability showed signs of improvement.
However, in terms of net loss, the deficit expanded significantly as around 140 billion won of equity method valuation losses on associates and derivative valuation losses from convertible bond (CB) put options were recognized.
As a result, the consolidated net loss for 2025 ballooned to 241.5 billion won, a 123.61% increase year-on-year.
The debt-to-equity ratio also climbed from 36.1% in the previous year to 90.1% at the end of 2025, adding to the financial burden.
| Key Financial Indicators | 2024 (Consolidated) | 2025 (Consolidated) | YoY Change |
|---|---|---|---|
| Revenue | 68.1 billion KRW | 83.9 billion KRW | +23.17% |
| Operating Loss | -118.5 billion KRW | -106.9 billion KRW | Loss decreased by 9.73% |
| Net Loss | -108.0 billion KRW | -241.5 billion KRW | Loss increased by 123.61% |
| Debt-to-Equity Ratio | 36.1% | 90.1% | +54.0%p |
Valuation
Reflecting the day's decline, HLB's market capitalization stands around 6.35 trillion won (ranking 9th on the KOSDAQ).
Due to the nature of biotech growth stocks, applying traditional performance-based multiples such as price-to-earnings (PER) or EV/EBITDA is difficult.
Instead, given that the US first-line liver cancer treatment market is worth approximately 9.3 trillion won, the Price-to-Sales Ratio (PSR) perspective, which factors in expected post-approval value, is widely adopted.
HLB has already secured the clinical results necessary to compete with current market leaders like Roche's Tecentriq + Avastin and AstraZeneca's Imfinzi + Imjudo.
The median overall survival (mOS) of 23.8 months demonstrated in its global Phase 3 clinical trial was published in the world-renowned journal The Lancet, validating its efficacy over existing approved treatments.
However, because the current market cap reflects future value based on successful drug approval scenarios, an actual regulatory approval is prerequisite to easing valuation pressures.
Expert & Institutional Analysis
Securities analysts and research institution experts consistently state that the success of this resubmission depends on meeting Chemistry, Manufacturing, and Controls (CMC) standards rather than clinical efficacy itself.
This is because the two previous CRLs focused primarily on management deficiencies at the manufacturing facilities.
Recently, speculation has arisen regarding the possibility of the FDA using alternative assessment tools (Remote Interactive Evaluations, or RIE) like paper-based reviews instead of conducting an on-site inspection of the camrelizumab facility.
[Image: /stdaily/uploads/202606/gen_6a3a3d9a391929.22140856.png]
According to guidance published by the FDA in September 2025, regulations do allow for remote assessments and document reviews to replace physical inspections under certain conditions.
However, skeptics argue that since the facility was previously rejected due to compliance issues, an on-site verification process will be mandatory.
Meanwhile, in terms of market flow, the news that global asset manager BlackRock increased its stake in HLB from 5.01% to 6.05% is cited as a supporting factor for foreign capital inflows.
Risk Factors
The most dominant risk factor is undoubtedly the uncertainty surrounding CMC compliance.
No matter how excellent the recipe (clinical data) is, if the kitchen (manufacturing plant) cannot prove consistent standards, this third attempt may hit unexpected obstacles.
Because detailed regulatory processes and final results are difficult to fully disclose with total transparency, a mix of expectation and anxiety could continue to fuel high volatility in the stock price.
Financially, an annual cash outflow of over 100 billion won for clinical trials and commercialization prep remains a heavy burden.
If the FDA approval is delayed further or another CRL is issued, the commercialization timeline will be sent back to square one.
The resulting need for additional capital raising poses a constant risk of share dilution for current shareholders.
Investment Outlook
Reflecting the heightened volatility in both markets, the Fear and Greed Index for both KOSPI and NASDAQ indicates a "Fear" state.
- KOSPI Fear & Greed: Current Fear (28.8), 1 week ago Neutral (53.7), 1 month ago Neutral (58.6), 3 months ago Fear (33.5)
- NASDAQ Fear & Greed: Current Fear (34.7), 1 week ago Fear (39.1), 1 month ago Neutral (59), 3 months ago Neutral (56.6)
In an environment where macro liquidity is tightening and market sentiment is dampened, individual clinical events can easily lead to binary outcomes.
Therefore, rather than solely chasing the upside scenario of maximizing global licensing value upon approval, investors should keep downside risks—such as unconfirmed inspection delays or requests for further supplements—fully in mind.
Staying calm ahead of the major decision just a month away and maintaining a diversified risk strategy across portfolios is highly advised.
Investor Checklist Q&A
Q1: What is the review classification for the FDA's final decision (PDUFA) scheduled for July 23?
A1: This resubmission has been classified as "Class 2," which focuses on reviewing previously identified deficiencies. Under this classification, the target action date is set for July 23, within six months of the acceptance date (January 2026).
Q2: What were the actual reasons the two previous drug approvals were deferred?
A2: There were no issues raised regarding the safety or efficacy data of the drug itself. However, the FDA issued CRLs due to facility deficiencies discovered during the CMC process of the immunotherapy "camrelizumab," which is handled by its partner Hengrui Medicine.
Q3: Can we rely on the possibility of a paper-based approval through the "Remote Interactive Evaluation (RIE)" system mentioned recently?
A3: The FDA indeed has alternative assessment tools to complete reviews through document evaluation instead of physical site visits, and there are several recent precedents. However, opinions in the industry remain split between optimists and skeptics on whether a facility that was rejected twice before can be cleared solely via a paper review without an on-site visit.
Q4: Aside from the July liver cancer treatment decision, what other pipelines is HLB advancing?
A4: Through its subsidiary Elevar, HLB is undergoing FDA review for "lirafugratinib," an FGFR2-targeted second-line treatment candidate for cholangiocarcinoma, with a target date of September 27, 2026. Additionally, as of June 19, the company officially initiated global Phase 2 clinical trial dosing for a tumor-agnostic indication expansion targeting all solid tumors with identified genetic mutations.
Q5: How are the financial risks associated with ongoing operating losses and rising debt assessed?
A5: Due to annual operating losses exceeding 100 billion won and equity method losses, the net loss reached 241.5 billion won in 2025, and the debt-to-equity ratio rose sharply to 90.1%. If the approval timeline is pushed back again, concerns over shareholder value dilution through capital increases could rise, making close monitoring of cash management essential.