HUTCHMED’s ATLED (fanregratinib) receives conditional NMPA approval in China for previously treated advanced ICC with FGFR2 fusions or rearrangements.
Written By: Siddhi Bhadekar, M. Pharm (QA)
Reviewed By: Pharmacally Editorial Team
China’s National Medical Products Administration (NMPA) has granted conditional approval to fanregratinib, marketed in China as ATLED®, for adults with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) harboring fibroblast growth factor receptor 2 (FGFR2) fusions or rearrangements who have previously received systemic therapy.
HUTCHMED (China) Limited announced the approval on August 28, 2026. Fanregratinib (HMPL-453) is a novel, highly selective, and potent oral inhibitor targeting FGFR1, FGFR2, and FGFR3, providing a new biomarker-defined targeted treatment option for this patient population.
NMPA Approval and Approved Patient Population
The conditional approval applies specifically to adults with advanced, metastatic, or unresectable ICC whose tumors harbor an FGFR2 fusion or rearrangement and who have experienced disease progression following at least one prior systemic therapy.
ICC is an aggressive malignancy arising from the intrahepatic biliary epithelium. It accounts for approximately 8.2% to 15.0% of primary liver cancers and represents the second most common form of liver cancer after hepatocellular carcinoma. The five-year overall survival rate for ICC is approximately 9%. Globally, FGFR2 fusions or rearrangements are detected in approximately 10% to 15% of ICC patients, defining a molecularly distinct subgroup requiring targeted therapeutic strategies.
Mechanism of Action: Selective FGFR1/2/3 Inhibition
Fanregratinib is an oral, highly selective, and potent small-molecule inhibitor targeting FGFR1, FGFR2, and FGFR3. Aberrant FGFR signaling serves as a key oncogenic driver of tumor proliferation, blood vessel formation (angiogenesis), and resistance to standard anticancer therapies. By selectively blocking FGFR1/2/3 signaling cascades, fanregratinib disrupts tumor cell growth and survival driven by these genetic alterations.
Clinical Evidence from the Pivotal Phase II Registration Cohort
The NMPA approval is supported by data from the Phase II registration cohort of a single-arm, multicenter, open-label pivotal Phase II/IIIb clinical trial conducted in China (NCT04353375). Primary results from the study were presented at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2026.
The trial met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%) in pretreated patients with advanced FGFR2-altered ICC.
Key clinical endpoints evaluated in the study include:
- Median Time to Response (TTR): 1.4 months (demonstrating rapid onset of action)
- Disease Control Rate (DCR): 83.9% (95% CI: 74.5%–90.9%)
- Median Duration of Response (DoR): 6.9 months (95% CI: 5.6–8.5)
- Median Progression-Free Survival (PFS): 6.9 months (95% CI: 4.1–8.2)
- Median Overall Survival (OS): 16.6 months (95% CI: 12.4–16.6)
Confirmatory Phase IIIb Trial
To fulfill the requirements of the NMPA’s conditional approval pathway, the Phase IIIb portion of the trial serves as the confirmatory study to further evaluate and validate the long-term clinical benefit and safety profile of ATLED® in this clinical setting. Patient enrollment for the confirmatory Phase IIIb cohort was initiated in January 2026 and remains ongoing.
Leadership Perspective & Commercialization
Mr. Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, emphasized that ICC represents a major subtype of primary liver cancer with a substantial disease burden and historically limited targeted therapeutic options. He noted that the NMPA approval of ATLED® addresses a critical therapeutic gap in China by offering a precision treatment alternative for pretreated advanced ICC patients.
HUTCHMED confirmed that it maintains full worldwide commercial rights to fanregratinib (HMPL-453) and is preparing to utilize its established oncology commercial infrastructure in China to deliver the precision therapy to eligible patients.
Reference
About the Writer
Siddhi Rajendra Bhadekar (Linkedin) is an M.Pharm professional with expertise in medical and scientific writing, literature review, publication writing, and evidence synthesis, supported by four peer-reviewed publications.
She brings working knowledge of ICH-GCP, MedDRA, pharmacovigilance, ADR/AE reporting, clinical data management, and regulatory documentation.
With experience across pharmaceutical R&D, Quality Control, and Quality Assurance, she combines scientific research skills with strong attention to accuracy and detail.
Her background in manuscript development, publication planning, and scientific communication enables her to translate complex healthcare information into clear, reliable content.