HLB's Antibody-Drug Conjugate Therapy Advances to FDA Review
The U.S. Food and Drug Administration (FDA) has officially accepted HLB's (028300) resubmission for review, initiating a six-month evaluation process for its novel hepatocellular carcinoma treatment. With an anticipated approval date of April 9, 2027, this development follows HLB's groundbreaking approval for its biliary tract cancer drug in September, solidifying its presence in the global oncology market.
HLB, having secured its first oncology drug approval in the U.S. last September, has now progressed its liver cancer therapy to the FDA's full review stage. The FDA classified the resubmission for the combination therapy of ribociclib and camrelizumab as a Class 2 review, setting a goal approval date of April 9, 2027. Consequently, the likelihood of approval this year has diminished, and the focus shifts to the outcome of the global Phase 3 trial, which demonstrated an impressive 8.6-month increase in survival duration compared to existing treatments.
HLB's U.S. subsidiary, Eleva Therapeutics, received notification from the FDA regarding the commencement of the full review process for its New Drug Application (NDA) for the combination therapy of ribociclib and camrelizumab as a first-line treatment for hepatocellular carcinoma. This milestone was announced by HLB on December 4th.
FDA Review Process and Timeline
The FDA's resubmission review process is divided into two classes, with Class 1 typically taking two months and Class 2 taking six months, depending on the scope of the required revisions. This resubmission for Eleva's ribociclib has been classified as Class 2, with a review goal date of April 9, 2027, according to the Prescription Drug User Fee Act (PDUFA). This date marks the FDA's target for completing the review, but it does not guarantee approval.
Expanding Oncology Portfolio in the U.S.
HLB secured FDA approval for its drug, Rifiktu (generic name: lirafugratinib), on September 23, 2023. Rifiktu is intended for the treatment of locally advanced or metastatic bile duct cancer in adults who have received prior treatment and have been identified as having FGFR2 gene fusion or rearrangement.
Elleva's Pipeline Expansion and Commercialization Opportunities
Elleva has been preparing for its U.S. launch, holding the global exclusive commercialization license for Lifcthu's novel therapy. With the potential approval of its new liver cancer treatment, the company can offer two innovative cancer therapies targeting different types of cancer in the U.S. market. The experience gained from the FDA approval process and the established local business infrastructure for Lifcthu can be leveraged to support the commercialization of subsequent pipeline assets.
Ribociclib, an oral targeted therapy that inhibits tumor angiogenesis, and Camrelizumab, an immune checkpoint inhibitor targeting PD-1, are the two drugs in Elleva's portfolio. Their combination therapy was approved in China in 2023 as a first-line treatment for unresectable or metastatic hepatocellular carcinoma. Elleva holds the commercialization rights for this combination therapy in regions excluding China and South Korea.
The 23.8-month survival data reported in the key global Phase 3 trial for primary liver cancer treatment is among the longest reported for this indication. This duration is comparable to the 23.7 months achieved by Bristol Myers Squibb's Opdivo and Yervoy combination therapy in the CheckMate-9DW trial. While these results are from different clinical trials, they do not directly indicate a superiority between the treatments.
As Elleva advances its pipeline, investors will closely monitor the potential impact of these late-stage assets on the company's valuation and growth prospects. The successful commercialization of these therapies could drive significant revenue growth and establish Elleva as a key player in the oncology space.
Late-Stage Clinical Trial Results Published, Highlighting Promising Combination Therapy
The final analysis of the CARES-310 study was published in the international medical journal, The Lancet Oncology, in December 2025. The combination therapy of ribociclib and camrelizumab has been included as a primary treatment option for advanced hepatocellular carcinoma in both the Barcelona Liver Cancer Clinical Practice Guidelines (BCLC) and the European Society for Medical Oncology (ESMO) guidelines.
HLB has initiated the reapplication process, addressing the manufacturing and quality control concerns raised during the initial FDA review. This full review will involve an examination of supplemental data and requirements related to manufacturing and quality.
Kim Dong-Gun, CEO of Eleva Therapeutics, stated, "Through the CARES-310 research, we have identified the potential for significant survival benefits with the combination of ribociclib and camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma patients." He further commented, "Now that the full review has commenced, we will work closely with Zai Lab to ensure a thorough examination by the FDA."
The potential commercialization of this combination therapy could provide a significant advancement in the treatment of liver cancer, offering new hope to patients.
