[비즈한국] The combination therapy of the liver cancer treatment Rivoceranib and Camrelizumab from HLB, which had previously received three Complete Response Letters (CRLs) from the U.S. Food and Drug Administration (FDA), has re-entered the approval process. With the resubmission of the new drug application to the FDA on the 9th, HLB expressed strong confidence in this latest attempt, stating that the Chemistry, Manufacturing, and Controls (CMC) issues that had previously hindered progress have been fully resolved.
Kim Tae-hae, Chairman of the Bio Division at HLB Group, stated at the ‘HLB Group IR Day’ held at Hana Securities in Yeouido, Seoul, on the 15th, “Shareholders have suffered a great deal while we received three CRLs, and I have also had a very difficult time, but I truly believe this is the final hurdle.” He added, “Personally, I see a very high probability of being classified as ‘Class 1,’ and I look forward to sharing the news of the final FDA approval for the Rivoceranib-Camrelizumab combination within this year.”
Since its first application in 2023, HLB has received three CRLs and is now embarking on its fourth attempt at approval as of the 9th.
Chairman Kim explained that the first two CRLs were related to CMC issues with Camrelizumab, while the third was related to the FDA’s on-site inspection of the Rivoceranib manufacturing facility.
He noted, “All flagged issues regarding the Drug Substance (DS) and Drug Product (DP) were fully resolved in July and early October of this year.” When a company resubmits supplementary materials for a CRL, the FDA classifies it as Class 1 or Class 2 based on the content and scope of the review. Minor clarifications or slight data supplementation are classified as Class 1, while cases requiring new manufacturing facilities, additional inspections, or large-scale data reviews are classified as Class 2. The target review periods are 2 months and 6 months from the application date, respectively. HLB expects the review classification to be determined by November 9.
Chairman Jin Yang-gon: “There Were Hurdles, But We Will Ultimately Achieve Approval”
Jin Yang-gon, Chairman of the Board at HLB Group, also expressed confidence in the approval of Rivoceranib.
Chairman Jin stated, “When many people said that technology export was the only answer, we judged it to be a ‘rain-dependent’ business that leaves our fate in the hands of others,” adding, “While there were several hurdles in the process of getting the liver cancer drug approved, I have firm faith that we will ultimately be approved.”
He emphasized, “What we have cultivated is not just a small flower, but the tree itself capable of blooming countless flowers in the future,” adding, “All of our pipelines will run on the highway we have built.”
FDA-Approved Bile Duct Cancer Treatment 'Rivectu' Targets Direct U.S. Sales and Q4 Launch
During the IR event, the commercialization strategy for the bile duct cancer treatment Rivectu, which received FDA approval last month, was also introduced. Elevar Therapeutics, the U.S. subsidiary holding global rights, plans to pursue direct sales in the U.S. market and launch it in the fourth quarter of this year. The strategy is to leverage the sales network built in the U.S. ahead of the Rivoceranib FDA approval.
For global markets, including Europe, the company plans to utilize a partnership model. In Europe, the Marketing Authorization Application (MAA) is currently under formal review by the European Medicines Agency (EMA).
Next Up After Rivectu and Rivoceranib is RGN-259… Topline Results Due in November Phase 3
Among HLB Group’s pipeline, the neurotrophic keratitis treatment RGN-259 from HLB Therapeutics is garnering attention as the successor to Rivectu and Rivoceranib.
The U.S. Phase 3 clinical trial concluded in August, and the topline results are scheduled to be released in mid-November. Ahn Ki-keun, CEO of HLB Therapeutics, said, “This U.S. clinical trial had a severe patient ratio reaching 80% with a low dropout rate,” adding, “We expect significantly superior results compared to the European data.”
If the clinical results are successful, HLB Therapeutics plans to pursue an FDA Type C meeting in the second quarter of next year and seek a marketing rights transfer agreement with a global big pharma company in the third quarter.