[E-Daily Reporter NA EUN-KYUNG ] HLB INC.(028300)announced on the 10th that its U.S. partner, Elevar Therapeutics, had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the U.S. marketing approval for the combination therapy of riboceranib and camrelizumab, a first-line treatment for liver cancer. This marks the third CRL.

According to the company, Elevar received the CRL from the FDA on the 9th (local time). The FDA communicated deficiencies identified during a Good Manufacturing Practice (GMP) inspection and explained that an additional inspection may be conducted if the manufacturing facility is deemed to meet GMP standards. The FDA also stated that the deficiencies identified during the inspection may not be limited to this specific marketing authorization application.

HLB INC. acquired the U.S. biotech company Eleva in 2021, and Eleva is responsible for the development and approval process of Riboceranib in the United States. HLB INC. announced that it plans to work with Eleva to promptly address the issues raised by the FDA and then resubmit the marketing authorization application.

The riboceranib and camrelizumab combination therapy has now received three requests for additional information from the FDA, following the first Complete Response Letter (CRL) in May 2024 and the second CRL in 2025.