HLB’s liver cancer drug combination therapy has been rejected by the U.S. Food and Drug Administration for the second time, dealing a blow to the South Korean company’s ambitions to bring its treatment to the American market.
The FDA issued a complete response letter citing unresolved chemistry, manufacturing, and controls issues with Camrelizumab, a drug developed by China’s Jiangsu Hengrui Pharmaceuticals that is used in combination with HLB’s Rivoceranib, the company announced Thursday.
The setback follows a previous rejection last year that raised concerns about both manufacturing and clinical site inspections. HLB had hoped to become only the second South Korean company to secure FDA approval for a domestically developed cancer drug, following Yuhan Corp.’s lung cancer treatment Lecraza, which was approved in August.
HLB Chairman Jin Yang-gon expressed disappointment but remained determined, noting that the company would work with Hengrui to identify and address the specific deficiencies. The Chinese pharmaceutical partner will engage with the FDA to clarify the exact issues requiring resolution.
Once HLB resubmits its application, the FDA will set a new review date. The timeline for potential approval remains uncertain, as the agency may require another on-site inspection or simply conduct a document-based evaluation depending on the nature of the corrections.
