Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 138

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 138
---
3. On November 9, 2023, the FDA approved fruquintinib for adults with metastatic CRC who have been previously treated with fluoropyrimidine-, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti-VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. Fruquintinib is the first and only selective inhibitor of all three VEGF receptor kinases approved in the U. S. for previously treated metastatic CRC regardless of biomarker status.

Table of Contents

For EMC, the NMPA granted Breakthrough Therapy Designation to the combination of fruquintinib and Tyvyt In July 2023. Supported by data from FRUSICA-1 China Phase II registrational study in 2L EMC patients with pMMR status, the NMPA accepted NDA submission and granted priority review status in April 2024. Based on the study results, NMPA granted conditional approval in December 2024 for the treatment of patients with advanced EMC with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation.

Fruquintinib Pre-clinical Evidence

Pre-clinical trials have demonstrated that fruquintinib is a highly selective VEGFR 1, 2 and 3 inhibitor with high potency and low cell toxicity at the enzymatic and cellular levels. In a kinase selectivity screening, fruquintinib was found to be approximately 250 times more selective to VEGFR 3 than to the next non-VEGFR kinase.

Fruquintinib Clinical Development

Fruquintinib Monotherapy - Colorectal Cancer

  Treatment         Trial Name, Patient Focus      Sites       Phase      Status/Plan                                   NCT #        
  Fruquintinib      FRESCO-2: 4L CRC               Global      III        Approved for CRC & launched in the U. S.      NCT04322539  
                                                                          Nov 2023; in the E. U. Jun 2024, in                        
                                                                          Argentina, Australia, Canada, Israel,                      
                                                                          Japan, Singapore, Switzerland, UAE &                       
                                                                          U. K. in H2 2024, & South Korea in Mar                     
                                                                          2025                                                       
  Fruquintinib      FRESCO: 3L CRC                 China       III