HLB, “Apply for riboceranib pre-NDA meeting with US FDA”

HLB (HLB) announced on the 13th that its subsidiary Eleva and its partner, Hangseo Pharmaceutical of China, had applied for a pre-NDA meeting with the US Food and Drug Administration (FDA) for approval for ‘Rivoceranib’ as the first-line treatment for liver cancer.

HLB logo.

The Pre-NDA meeting (pre-meeting for new drug approval application) is a procedure to receive pre-consultation from the FDA before the NDA on the direction of the new drug approval application and submitted data. HLB predicted that the Pre-NDA meeting would be held in mid-October at the latest.

HLB announced in May that the statistical significance of the primary efficacy indicator was satisfied as a result of co-administration of riboceranib and ‘camrelizumab’ in a phase 3 clinical trial for primary liver cancer patients. HLB will disclose all data at the European Cancer Society (ESMO) to be held in September.

In addition, HLB announced that its subsidiary Eleva is preparing for the accelerated approval process for adenocarcinoma, which has completed riboceranib’s phase 2 alone.

In-geun Jang, Executive Vice President of HLB’s Bio Strategic Planning Division, said, “The riboceranib combination has proven superior efficacy compared to Nexavar in the field of primary treatment for liver cancer, where many global pharmaceutical companies have failed. We will do our best to proceed with the NDA process as soon as possible by focusing on the preparation of Pre-NDA materials for the rest of the period.”

Meanwhile, HLB announced on the 12th that it had decided to issue a capital increase to prepare for the approval and commercialization of a new drug riboceranib. The bequest amount is 325.6 billion won, and shareholders have the right to subscribe for 0.9 shares for every 10 shares, and the planned issuance price is 34,050 won.

From the 16th to the 21st of October, subscription is prohibited during the short selling trading period.

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