As top domestic pharmaceutical and biotech corporations by market capitalization show volatility, HLB is extending its gains. The rise is seen as reflecting investors' expectations ahead of next month's U.S. Food and Drug Administration (FDA) decision on approval of a new liver cancer drug. However, some say it is too early to conclude on approval odds because a few variables remain, such as whether the FDA will inspect the Chinese partner's manufacturing facility.
On the 25th, according to the Korea Exchange (KRX), HLB closed at 50,300 won, up 5.89% from the previous day. Investor interest is concentrating ahead of the FDA approval decision for the combination therapy of the liver cancer drug "Rivoceranib," slated for next month.
On the 23rd, among the top 10 domestic pharmaceutical and biotech stocks by market cap, nine, including Samsung Biologics, fell, while HLB rose 5.61%, climbing to No. 6 in market cap ranking.
The market sees the scheduled review for approval of the liver cancer drug next month as driving the stock's rise. Under the Prescription Drug User Fee Act (PDUFA), the FDA must decide by Jul. 23 whether to approve HLB's combination therapy of "Rivoceranib" for liver cancer.
Rivoceranib is a targeted anticancer drug developed by Elevar Therapeutics, HLB's U.S. subsidiary. It is seeking approval as a first-line therapy for hepatocellular carcinoma in combination with "Camrelizumab," an immunotherapy from China's Jiangsu Hengrui Pharmaceuticals. This is the third FDA attempt, following May 2023 and May 2024.
In the previous two reviews, the FDA did not raise issues with Rivoceranib's efficacy or safety. However, it issued complete response letters (CRLs) requesting supplementation on matters related to Camrelizumab's production facility and chemistry, manufacturing and controls (CMC).
Accordingly, expectations have grown in the market that the CMC issues could be resolved in this review and approval could be granted. In particular, investor sentiment was boosted by the fact that BlackRock, the world's largest asset manager, increased its stake in HLB in Mar., becoming the No. 2 shareholder after Chair Jin Yang-gon.
Still, it is unclear whether the stock's momentum will continue. With less than a month left until the FDA's approval deadline, an inspection schedule for Hengrui's manufacturing facility has not yet been set. Given that both prior CRLs were related to CMC issues, some analysts say it will be difficult to decide on approval without a facility inspection.
Others, however, note that an on-site inspection is not mandatory. They say the review could proceed by using the RLI (Remote Regulatory Assessment) system introduced by the FDA during the COVID-19 pandemic to evaluate submitted manufacturing data or conduct remote inspections.
An HLB official said, "There is a possibility the review could be conducted based on submitted materials instead of an on-site inspection, or via an unannounced remote inspection," adding, "Hengrui has completed preparations to respond whenever the FDA conducts an inspection." The two prior on-site inspections of Hengrui's manufacturing facilities each reportedly lasted about a week.
Brokerages expect HLB's stock volatility to increase as the approval decision approaches. That is because the progress of the FDA review and any additional disclosures could directly affect investor sentiment.
Clinical results also underpin the high market expectations. The Rivoceranib–Camrelizumab combination therapy recorded a median overall survival (mOS) of 23.8 months in a global phase 3 clinical trial for patients with unresectable hepatocellular carcinoma. This is the longest among current first-line liver cancer therapies.
It has also been added to international treatment guidelines. The combination therapy was listed last year in the Barcelona Clinic Liver Cancer (BCLC) guidelines as a first-line treatment for advanced liver cancer, and was included as a first-line option in the 2025 guidelines of the European Society for Medical Oncology (ESMO).
HLB is also awaiting approval for another anticancer drug. The FDA's target action date for the cholangiocarcinoma treatment "Lirafugratinib" is Sept. 27. The FDA has designated the product for priority review, shortening the timeline by about four months compared with standard review.
An industry official said, "The overall biotech sector has been weak recently, and whether Rivoceranib wins FDA approval could be an event that triggers a rebound in domestic biotech stocks," adding, "Beyond HLB's success or failure, it will be a test bed for evaluating the domestic biotech industry's global new drug development capabilities."