Europe EditionHUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination ...
- HUTCHMED and Innovent jointly announced on June 5, 2025, that the China NMPA accepted the NDA for fruquintinib combined with sintilimab to treat advanced renal cell carcinoma in patients who failed prior tyrosine kinase inhibitor therapy.
- The approval follows encouraging outcomes from the FRUSICA-2 trial, a randomized, open-label study that assessed the efficacy and safety of combining fruquintinib with sintilimab compared to treatment with either axitinib or everolimus alone in patients receiving second-line therapy for advanced renal cell carcinoma.
- FRUSICA-2 achieved its primary goal of improving progression-free survival, evaluated through an independent, blinded review following RECIST 1.1 criteria, and also demonstrated enhanced objective response rate and duration of response, with a manageable safety profile and no unexpected adverse effects.
- At the October 9, 2024 data cutoff, a proof-of-concept study reported a 60% confirmed objective response rate, 85% disease control rate, median progression-free survival of 15.9 months, and a 36-month overall survival rate of 58.3%, supporting the NDA submission.
- The acceptance of the NDA marks an important milestone in addressing the lack of effective second-line treatment options for patients with advanced kidney cancer in China, with company executives highlighting the achievement and their commitment to improving patient access.
38 Articles
38 Articles
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Innovent and HUTCHMED Jointly Announce NDA Acceptance in China for Sintilimab Combination with Fruquintinib for the Treatment of Advanced Renal Cell Carcinoma
SAN FRANCISCO and SUZHOU, China, June 4, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other…
Hastings Tribune
Post RegisterHUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination ...
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 05, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) and Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801) today jointly announce that the New Drug Application (“NDA”) for the…
Globe Newswire
The Manila TimesHUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Renal Cell Carcinoma
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 05, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) and...
HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Renal Cell Carcinoma - HUTCHMED (China) (NASDAQ:HCM)
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 05, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) and Innovent Biologics, Inc. ("Innovent") (HKEX: 01801) today jointly announce that the New Drug Application ("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 tyrosi…
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