Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 137

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 137
---
 and provide more consistent target coverage. The tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction, suggests that it may be highly suitable for combinations with other anti-cancer therapies. We have partnered with Eli Lilly on fruiquintinib in China and Takeda outside of China. For more information, see “ - Overview of Our Collaborations - Eli Lilly” and “ - Overview of Our Collaborations - Takeda.”

Fruquintinib Mechanism of Action

During the development of cancer, tumors at an advanced stage can secrete large amounts of VEGF, a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor in order to provide greater blood flow, oxygen, and nutrients to fuel the rapid growth of the tumor. Since essentially all solid tumors require angiogenesis to progress beyond a few millimeters in diameter, VEGFR drugs have demonstrated benefits in a wide variety of tumor types. VEGF and other ligands can bind to three VEGF receptors, VEGFR 1, 2 and 3, each of which has been shown to play a role in angiogenesis. Inhibition of the VEGF/VEGFR signaling pathway can stop the growth of the vasculature around the tumor and starve the tumor of the nutrients and oxygen.

Fruquintinib Regulatory Status and Path

For CRC, supported by data from FRESCO China Phase III study, NMPA accepted our NDA submission for fruquintinib in June 2017. Fruquintinib was awarded priority review status by the NMPA in view of its clinical value in September 2017. In September 2018, fruquintinib was approved by the NMPA for the treatment of metastatic colorectal cancer patients, who have failed at least two prior systemic antineoplastic therapies including fluoropyrimidine, oxaliplatin and irinotecan, with or without prior use of anti-VEGF or anti-EGFR therapies. It was launched in November 2018.

Building on the data collected from the FRESCO study, we initiated FRESCO-2 global Phase III study. Based on the successful results of FRESCO-2 and FRESCO, the FDA accepted NDA submission and granted priority review status in May 2023, with a PDUFA date of Novebmer 30, 202