BlackRock, the world's largest asset manager, has become the No. 2 shareholder of HLB. BlackRock said the move was "for simple investment purposes," but the market is focused on whether the U.S. Food and Drug Administration (FDA) will grant a third approval for the liver cancer drug. Because the company's value could change significantly depending on the decision, some interpret the move as global capital having detected a positive signal from the FDA and moving preemptively to secure equity.
According to the Financial Supervisory Service's electronic disclosure system on the 4th, BlackRock Fund Advisors, an affiliate of BlackRock, disclosed the previous day that it bought 6,664,921 HLB shares (5.01%). Based on the closing price that day, the stake is worth about 304.4 billion won. With this, BlackRock became the second-largest shareholder after Chair Jin Yang-gon (7.23%).
As the world's largest asset manager secured more than 5% equity to become a major shareholder, analysts say the investment leans toward mid- to long-term growth rather than short-term gains.
A memorandum of understanding (MOU) between President Lee Jae-myung and BlackRock Chair Larry Fink is also cited as a key backdrop. In Sep. last year, President Lee attended the "AI Connect Summit" and signed an MOU with Fink for cooperation in AI and renewable energy infrastructure. At the time, Fink said, "We will actively cooperate so that Korea can become the 'AI capital of Asia.'"
Since then, BlackRock Fund Advisors disclosed a 5% equity stake in SK hynix recently and has invested in Samsung Electro-Mechanics, expanding its investments into Korea's semiconductor and advanced industries. This is known to be the first full-fledged equity investment case in the biotech sector.
Market attention is centered on whether HLB's liver cancer drug "Rivoceranib" will win FDA approval. Rivoceranib is a targeted anticancer therapy developed by HLB's U.S. subsidiary Elevar Therapeutics, and the company is seeking FDA approval for its use in combination with the immune checkpoint inhibitor "Camrelizumab" from China's Hengrui Pharma.
The two companies first applied for FDA approval in May 2023 but were turned down. The reason was not issues with Rivoceranib's efficacy or safety, but manufacturing and quality control (CMC) observations related to Camrelizumab's production process and facilities. Through a complete response letter (CRL), the FDA requested improvements in those areas.
Hengrui Pharma subsequently carried out remedial work and passed the FDA's Bioresearch Monitoring (BIMO) inspections of global phase 3 trial sites. However, in the May 2024 reattempt, they again fell short because CMC-related supplements were deemed insufficient. The two companies filed a third new drug application in Jan.
According to the company, the Rivoceranib–Camrelizumab combination recorded a median overall survival (mOS) of 23.8 months in global phase 3 for patients with unresectable hepatocellular carcinoma. It said this is currently the longest survival among first-line therapies for liver cancer. The company added that subgroup analyses also showed consistent efficacy and manageable safety.
Inclusions in international guidelines have followed. The Rivoceranib combination was included last year in the "Barcelona Clinic Liver Cancer (BCLC) guideline" as a first-line therapy for advanced liver cancer, and it was reflected as a first-line option in the European Society for Medical Oncology's 2025 guideline. The industry expects that such listings in international guidelines could serve as a positive signal in the FDA approval process.
In the end, BlackRock's rise to the No. 2 shareholder is seen as more than a simple equity change. The FDA's third review result is expected to be a watershed for HLB's future value among corporations.
An HLB official said, "Our partner Hengrui Pharma successfully out-licensed technology to GSK plc last year, winning recognition for its capabilities, and we believe many of the CMC-related supplemental issues have been largely resolved," adding, "We are looking forward to the result of this third review."