HUTCHMED (China) Limited announced results from a pivotal Phase II registration study of fanregratinib (HMPL-453) in patients with intrahepatic cholangiocarcinoma (ICC). The data, presented at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress, demonstrated a clinically meaningful objective response rate of 42.5% and a median overall survival of 16.6 months. These findings support fanregratinib as a potential new treatment option for pretreated advanced ICC patients harboring FGFR2-fusions/rearrangements.

Supported by the study data, a New Drug Application (NDA) for fanregratinib was accepted for review and granted priority review by the China National Medical Products Administration (NMPA) in December 2025. The application targets the treatment of adult patients with advanced, metastatic, or unresectable ICC with FGFR2 fusion/rearrangement who have previously received systemic therapy.

Clinical Trial Results

The single-arm, multi-center, open-label Phase II trial was conducted across 53 sites in China. All enrolled patients had received at least one line of systemic therapy, including chemotherapy, and 72% had prior immunotherapy exposure. The study met its primary endpoint, showing an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%).

Key secondary endpoints indicated consistent clinical activity and rapid onset of action. The median time to response was 1.4 months. Additional efficacy metrics are detailed in the table below:

Safety Profile

Fanregratinib exhibited a manageable safety profile consistent with the known mechanism of selective FGFR inhibitors. Drug-related adverse events of Grade 3 or greater were reported in 48.3% of patients. The most common events were elevations in liver enzymes and palmar-plantar erythrodysesthesia syndrome (PPES). Treatment discontinuation due to drug-related adverse events occurred in 2.2% of patients, with no treatment-related deaths recorded.

Professor Jianming Xu of the Chinese PLA General Hospital and leading Principal Investigator of the study emphasized the significance of the results. "The objective response rate and survival metrics achieved by fanregratinib clearly support its therapeutic value as a potent, selective oral treatment option," he stated.

HUTCHMED (China) Limited announced that sovleplenib demonstrated rapid and durable hemoglobin response with a favorable safety profile in the Phase III ESLIM-02 study for warm antibody autoimmune hemolytic anemia (wAIHA). The data, presented at the European Hematology Association Congress in Stockholm on June 11, 2026, highlights the drug's potential to address unmet needs in a treatment landscape lacking approved targeted therapies.

The China National Medical Products Administration (NMPA) accepted a New Drug Application for sovleplenib for review and granted it priority review in April 2026. The NMPA had previously granted Breakthrough Therapy Designation to sovleplenib for wAIHA in March 2026.

ESLIM-02 Study Design and Results

ESLIM-02 is a randomized, double-blind, placebo-controlled Phase II/III study conducted in China. It enrolled adult patients with primary or secondary wAIHA who had relapsed or were refractory to at least one prior line of standard treatment. In the Phase III part, 90 patients were randomized 1:1 to receive either sovleplenib 300 mg (n=44) or placebo (n=46) once daily for 24 weeks.

The study met its primary endpoint, showing a significantly higher durable response rate during weeks 5–24 for the sovleplenib arm compared to placebo.

Sovleplenib achieved a median time to response of 3.1 weeks versus 6.3 weeks for placebo. The median cumulative duration of response among overall responders was 16.1 weeks for sovleplenib compared to 6.1 weeks for placebo. Improvements in hemolytic markers were also observed, indicating alleviation of active hemolysis.

Safety and Subgroup Analysis

Sovleplenib demonstrated a favorable safety profile, with Grade ≥3 treatment-emergent adverse events (TEAE) reported in 43% of patients in the sovleplenib arm versus 59% in the placebo arm. The most common Grade ≥3 TEAEs were warm autoimmune hemolytic anemia (18% vs 43%) and upper respiratory tract infection (2% vs 11%). There were no TEAE-related deaths or treatment discontinuations in the sovleplenib group.

Efficacy findings remained consistent across sensitivity and subgroup analyses. Notably, in patients who had received prior rituximab therapy, the durable response rate was 69% for sovleplenib versus 16% for placebo (p=0.0022).