HLB Jumps on FDA Review Hopes...Seers Rznomics Rally[K-Bio Pulse]

[Song Young Doo, Edaily Reporter] On June 16, South Korea’s pharmaceutical and biotechnology stocks traded largely on company-specific catalysts, including regulatory expectations, business momentum, and shareholder-friendly initiatives.

HLB Group shares advanced on speculation that the FDA review of its liver cancer therapy could proceed without an on-site manufacturing inspection. SEERS climbed after its AI-powered inpatient monitoring platform surpassed 200 hospital installations, while Rznomics gained sharply following the announcement of a 100% bonus issue.

HLB Pharm Stock Trend.(Source=KG Zeroin MP Doctor)

Possibility Raised That Rivoceranib-Camrelizumab Review Could Proceed Without On-Site FDA Inspection

According to KG Zeroin’s MP Doctor(formerly Market Point), HLB Group affiliates posted solid gains. HLB rose 6.26%(won 2,850), HLB Pharm gained 9.85%(won 1,080), HLB Life Science climbed 7.31%(won 225), HLB Global advanced 6.00%(won 90), and HLB Therapeutics increased 5.25%(won 130).

The rally appears to have been driven by expectations that the FDA’s review of the rivoceranib-camrelizumab combination therapy may be completed through documentation rather than an on-site inspection.

The rivoceranib-camrelizumab combination is being jointly developed by HLB’s U.S. subsidiary Elevar Therapeutics and Hengrui Pharmaceuticals as a first-line treatment for hepatocellular carcinoma.

In January, the companies resubmitted the New Drug Application(NDA) for rivoceranib and the Biologics License Application(BLA) for camrelizumab. The FDA accepted the applications for substantive review and set a Prescription Drug User Fee Act(PDUFA) target date of July 23.

The market has viewed Chemistry, Manufacturing and Controls(CMC) verification of camrelizumab’s manufacturing facility as the key issue in this review cycle. The combination therapy previously received Complete Response Letters(CRLs) in May 2024 and March 2025, both related to camrelizumab manufacturing and quality-control issues.

According to HLB, Hengrui has already submitted all manufacturing-related documents requested by the FDA and has not received any additional requests for information or notifications regarding inspections. The company maintains that the absence of an on-site inspection does not necessarily imply delays in the approval process.

An HLB official told local media that Hengrui has completed all requested submissions and has not received any separate communication regarding inspections.

The official also noted that the FDA operates a Reports in Lieu of Inspection(RLI) system under which submitted documents and manufacturing records can be used in place of physical inspections in certain cases adding that several recent precedents exist. However the company emphasized that multiple outcomes remain possible until the FDA reaches its final decision.

In other words industry observers believe that the FDA’s document-based review framework could potentially be applied to Hengrui’s manufacturing assessment which has been the central issue in the approval process for the rivoceranib-camrelizumab combination.

However, the industry generally believes it remains unlikely that the FDA will ultimately replace an on-site CMC inspection with document review alone.



SEERS Jumps 12% as thynC Surpasses 200 Hospital Installations

Wearable medical AI company SEERS posted strong gains after announcing that more than 200 medical institutions have adopted its AI inpatient monitoring platform thynC™ alongside the recruitment of a key industry executive. Investors focused less on the number of installations itself and more on the potential for hospital bed expansion and accumulation of operational data.

According to the Korea Exchange, SEERS shares rose 12.15%(won 3,500) to close at won 32,300.

The stock’s momentum was driven by continued expansion of the thynC business and efforts to strengthen customer management capabilities. The company announced that thynC installations have exceeded 200 healthcare institutions and that it has recruited Jung Hoon, formerly of Daiichi Sankyo Korea, to enhance customer experience and operational excellence.

Jung has nearly 19 years of experience in pharmaceutical sales, marketing, and medical affairs. He previously led marketing activities for the anticoagulant Lixiana and built extensive relationships with physicians at major university hospitals and tertiary medical centers. SEERS expects his expertise to contribute to improving customer experience and operational management for thynC.

Investors appear to be paying greater attention to the rapid accumulation of operational references than to the milestone of 200 installations itself. AI-based inpatient monitoring platforms become more competitive as they gather real-world hospital operational data, improving algorithms and increasing physician confidence.

A SEERS official said, “thynC is not simply about increasing the number of installed hospitals but about building barriers to entry through accumulated operational references. As deployments surpass 200 institutions, operational know-how and AI-generated data continue to grow, becoming the key reason hospitals remain long-term users of the platform.”

The platform is currently expanding into integrated nursing-care wards, internal medicine, cardiology, neurosurgery, VIP wards, and intensive care units. In tertiary hospitals in particular, initial deployments are often followed by expansion into additional departments, allowing both bed capacity and operational data to grow simultaneously.

The market believes this structure could translate into stronger future earnings, as expanding bed coverage increases recurring revenue while making it more difficult for competitors to replicate accumulated experience and data. Combined with the recruitment of a hospital-network specialist, investors also expect customer management and new deployments to accelerate.

The company added that expansion of hospital beds and operational data is creating a virtuous cycle and that it remains optimistic about growth prospects beyond the second quarter.



Rznomics Gains on 100% Bonus Issue Announcement

Rznomics surged after announcing a 100% bonus issue. On June 16, its shares rose 15.22%(won 13,500), driven by investor enthusiasm following the board’s decision to issue one new common share for every existing share held.

The company will issue 14,027,718 new shares, doubling the total number of outstanding shares from 14,027,718 to 28,055,436. Shareholders of record as of June 30 will receive one additional share for each existing share owned, with listing of the new shares scheduled for July 21. The bonus issue will be financed using additional paid-in capital of won 7.01 billion.

A bonus issue transfers retained capital into share capital and distributes additional shares to existing shareholders. Although shareholders receive more shares, their ownership percentages remain unchanged and the company’s theoretical value does not increase. Nevertheless, investors often view bonus issues positively for three reasons.

First, an increase in the number of tradable shares improves market liquidity, making high-priced stocks more accessible to retail investors. Second, bonus issues are generally interpreted as a signal of strong financial resources, since they require sufficient retained earnings or additional paid-in capital. Third, the market often views bonus issues as a shareholder-friendly gesture because they return value to shareholders without requiring an actual cash outflow.

However, experts caution that bonus issues do not increase a company’s intrinsic value. Because share prices are adjusted through ex-rights pricing after listing of the new shares, investors should focus on business fundamentals rather than short-term trading opportunities.

Rznomics is a KOSDAQ-listed biotechnology company developing gene therapies based on RNA trans-splicing ribozyme technology. Last year, it signed a platform licensing agreement with Eli Lilly worth up to approximately won 1.9 trillion, securing a major global pharmaceutical partnership. Its lead candidate, RZ-001, targeting liver cancer and glioblastoma, has received FDA Orphan Drug and Fast Track designations and is currently undergoing global clinical development.