HLB is undergoing simultaneous U.S. Food and Drug Administration (FDA) product approval reviews for both the rivoceranib + camrelizumab combination therapy, which previously faced two setbacks, and lirafugratinib. Elevar Therapeutics, HLB's U.S. subsidiary, and its partner, Hengrui Pharma, submitted an application for product approval of rivoceranib + camrelizumab, a new drug candidate for liver cancer, to the FDA on January 23. Subsequently, just four days later on January 27, Elevar submitted an additional application for product approval of lirafugratinib, a targeted therapy for FGFR2 fusion/rearrangement cholangiocarcinoma. The company's previous attempts to secure FDA approval for the rivoceranib combination therapy in 2024 and 2025 were unsuccessful. At that time, the FDA issued a Complete Response Letter (CRL), citing Chemistry, Manufacturing, and Controls (CMC) issues at Hengrui Pharma's camrelizumab production facility. However, the FDA did not raise concerns regarding the safety or efficacy of the rivoceranib combination therapy, instead requesting the submission of 3-6 months of stability data related to the drug product quality. HLB states that this resubmission for product approval fully addresses the supplementary requirements outlined during the previous review process. A company official explained that discussions regarding improvement directions and plans for camrelizumab's CMC issues were completed through a Type A meeting with the FDA. The application will now undergo approximately two months of acceptance review. If classified as Class 1, the review results will be communicated within three months; if classified as Class 2, within six months. It is anticipated that the product approval review results could be confirmed as early as March, or by July at the latest. The initial product approval application for the new cholangiocarcinoma drug, lirafugratinib, is also proceeding concurrently. The key research data utilized for this application includes the Phase 2 clinical trial results for lirafugratinib, which were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2026) on January 9. At that time, lirafugratinib demonstrated an objective response rate (ORR) of 46.5%, a disease control rate (DCR) of 96.5%, and a median duration of response (mDoR) of 11.8 months. The incidence of hyperphosphatemia and diarrhea was also lower compared to existing approved drugs. If designated for priority review, approval results could be known as early as September.