HLB announced through a regulatory filing that it has submitted a new drug application resubmission to the U.S. Food and Drug Administration (FDA) for its first-line liver cancer treatment, the 'rivoceranib and camrelizumab combination therapy.'

According to HLB, its U.S.-based subsidiary Elevar Therapeutics, Inc. submitted the resubmission for the new drug application of the combination therapy to the FDA on the 9th, local time.

Resubmission in Response to Complete Response Letter Received on July 9 This resubmission was made in response to the Complete Response Letter (CRL) HLB received from the FDA on July 9.

Review Period Ranges from Minimum 2 Months to Maximum 6 Months Depending on Class After receiving the resubmission, the FDA will determine the review period according to its review criteria and decide whether to approve the new drug application. Based on the FDA's classification standards, the review period is 2 months for Class 1 and 6 months for Class 2. The specific review period will be determined by the FDA after the submission is received.

Meanwhile, HLB disclosed the decision and confirmation date related to this resubmission as October 10, 2026.