South Korean pharmaceutical company HLB Group has announced plans to resubmit its targeted anticancer drug riboceranib for U.S. Food and Drug Administration (FDA) approval following a second rejection. The company's shares, which initially plummeted after the announcement of the FDA's decision, have since rebounded significantly as investors respond to the firm's commitment to pursue approval.
On May 20th, HLB disclosed that the FDA had requested supplementary documentation for riboceranib, a targeted anticancer drug developed by its U.S. subsidiary Eleva Therapeutics. This marks the second time the company has faced such a request, following a similar outcome in May 2023.
Manufacturing Issues Cited in FDA Decision
The FDA's concerns reportedly center on deficiencies in the manufacturing process of Hangseo Pharmaceutical, HLB's Chinese partner that produces camrelizumab, an immuno-oncology drug administered in combination with riboceranib. The combination therapy is the focus of HLB's approval application.
Chairman Jin Yang-gon addressed the situation in an online meeting on May 21st, stating, "The application for riboceranib + camrelizumab reauthorization will be made in May even if it is delayed for the longest time." He expressed optimism that "the FDA's decision to approve the product could be made as early as July."
Regulatory Classification and Market Impact
HLB maintains that the FDA's concerns fall under "Class 1" review items, which typically include labeling issues, safety updates, and minor data reanalysis. However, the company's previous submission was categorized as requiring "Class 2" review, which involves more substantial concerns including manufacturing facility evaluation.
If approved, riboceranib would become only the second South Korean-developed anticancer drug to receive FDA authorization, following Yuhan Corporation's lung cancer drug Leclaza, which gained approval in August 2023.
Market Response and Future Plans
Following the FDA's decision, HLB Group's stock prices initially plunged. However, by 10:30 a.m. on May 24th, HLB shares had rebounded to 51,800 won, representing an 11.40% increase from the previous day. Other group companies also saw significant recoveries, with HLB Pharmaceutical and HLB Life Sciences rising 18.71% and 17.70% respectively.
The market rebound reflects investor confidence in HLB's commitment to pursue FDA approval. Chairman Jin reinforced this commitment, stating, "We will re-challenge FDA approval as soon as possible and proceed with an application for approval from the European Medicines Agency (EMA) in July. Please be a little more patient and wait for the outcome."
Strategic Importance of FDA Approval
FDA approval represents a significant milestone for pharmaceutical companies seeking global market access. The United States accounts for approximately 40% of the world's drug trade, and FDA-approved medications typically enjoy competitive advantages not only in the U.S. market but also in Europe and Southeast Asia.
When asked about potential impacts from U.S.-China tensions on the approval process, given the Chinese origin of the partner drug camrelizumab, HLB expressed confidence that this would not be a factor, noting that other Chinese immuno-oncology drugs have successfully received FDA approval.
As HLB prepares its resubmission, the company has urged investors to remain patient while it navigates the regulatory process for what it hopes will become a significant addition to the global oncology treatment landscape.
