Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 395

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 395
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 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

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Treatment          Trial Name, Patient Focus       Sites        Phase       Status/Plan                                       NCT #      
Fruquintinib       FRESCO-2: 4L CRC                Global       III         Approved for CRC &amp; launched in the U.S.       NCT04322539
                                                                            Nov 2023; in the E.U. Jun 2024, in                           
                                                                            Argentina, Australia, Canada, Israel,                        
                                                                            Japan, Singapore, Switzerland, UAE &amp;                     
                                                                            U.K. in H2 2024, &amp; South Korea in Mar                    
                                                                            2025                                                         
Fruquintinib       FRESCO: 3L CRC                  China        III         Approved for 3L                                   NCT02314819
                                                                            CRC &amp; launched in                                        
                                                                            2018                                                         
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FRESCO-2: Phase III study of fruquintinib in >3L CRC (NCT04322539)
FRESCO-2 is a global Phase III randomized, double-blind, placebo-controlled registration study of fruquintinib in CRC patients who had progression on, or intolerance to, Lonsurf and/or Stivarga; prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild type, and anti-EGFR