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HUTCHMED and Innovent Announce NDA Acceptance for Fruquintinib and Sintilimab Combination in Renal Cell Carcinoma

Why we think this is good

The RNS announcement indicates that the NDA for the combination of fruquintinib and sintilimab for the treatment of advanced renal cell carcinoma has been accepted for review by the China NMPA. This is a positive regulatory development that brings the potential new treatment option one step closer to patients. However, the RNS does not provide any information about profit upgrades or trading significantly ahead of expectations, so the sentiment score is capped at 'Good' in line with the Very Good rating constraint.

Key Points

  • NDA for fruquintinib and sintilimab combination accepted for review by China NMPA
  • NDA supported by positive data from FRUSICA-2 study, meeting primary endpoint of progression-free survival
  • Combination showed improvements in secondary endpoints including objective response rate and duration of response
  • Represents an important step in addressing unmet need for new treatment options for advanced renal cell carcinoma in China

Summary

The biopharmaceutical company has announced that its NDA for a combination therapy to treat advanced renal cell carcinoma has been accepted for review, marking a key milestone in bringing this potential new treatment option to patients.

HUTCHMED and Innovent have announced that the NDA for the combination of fruquintinib and sintilimab for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment with one tyrosine kinase inhibitor has been accepted for review by the China National Medical Products Administration (NMPA). The NDA is supported by data from the FRUSICA-2 study, which met its primary endpoint of progression-free survival. The combination also demonstrated improvements in secondary endpoints including objective response rate and duration of response, with a tolerable safety profile. This represents an important step in addressing the unmet need for new treatment options for patients with advanced renal cell carcinoma in China.

Key Dates

June 5, 2025
NDA acceptance announcement
GENERAL UPDATE