HLB Jumps on FDA Review Hopes...Seers Rznomics Rally

This article was released as Pharm Edaily Premium Content on June 17, 2026, at 8:00 AM.[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 InspectionAccording 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 InstallationsWearable 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 manageme