[Edaily Reporter KIM SAE-MI ] HLB INC.(028300)has resubmitted its application to the U.S. Food and Drug Administration (FDA) for approval of the combination therapy of the new liver cancer drug riboceranib and camrelizumab. This comes approximately three months after receiving its third Complete Response Letter (CRL) last July.

HLB INC. announced on the 12th that its U.S. subsidiary, Eleva Therapeutics, and its Chinese partner, Hangzhou Pharmaceutical, submitted a New Drug Application (NDA) and Biologics License Application (BLA) to the FDA on the 9th (local time) for the combination therapy of riboceranib and camrelizumab as a first-line treatment for liver cancer.

This resubmission is a follow-up to the CRL received from the FDA on July 9. Previously, HLB INC. had received CRLs from the FDA in May 2024 and March of last year. Although the company resubmitted its application for approval in January of this year, its entry into the U.S. market was delayed again after receiving a third CRL in July.

The FDA’s recent inspection of the riboceranib manufacturing facilities has also been completed. Following the inspection of the drug substance (DS) manufacturing facility, the inspection of the drug product (DP) manufacturing facility was also concluded with a “Voluntary Action Recommendation” (VAI). A VAI is a classification assigned when certain issues are identified but no formal regulatory action is taken, and the company is required to voluntarily correct them.

After receiving the resubmitted application, the FDA will determine the review period based on the nature of the supplemental data. A review period of two months applies if the application is classified as Class 1, and six months if classified as Class 2.

Kim Dong-geon, CEO of Eleva Therapeutics, stated, “Now that the manufacturing facility inspection process has been completed, we will work closely with the FDA to ensure that this approval review is successfully concluded based on the clinical value demonstrated in CARES-310.”