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Press releaseGlobeNewswire· May 21, 2026

HUTCHMED and Innovent Jointly Announce NMPA Approval for ELUNATE® (Fruquintinib) in Combination with TYVYT® (Sintilimab Injection) for the Treatment of Patients with Locally Advanced or Metastatic Renal Cell Carcinoma

View original at globenewswire.com
HUTCHMED and Innovent Jointly Announce NMPA Approval for ELUNATE® (Fruquintinib) in Combination with TYVYT® (Sintilimab Injection) for the Treatment of Patients with Locally Advanced or Metastatic Renal Cell Carcinoma HONG KONG and SHANGHAI and FLORHAM PARK, N.J., May 21, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limit…
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  • The rapid advancements in targeted therapies, immunotherapies, and their combination regimens have led to a significant evolution in the treatment landscape for advanced renal cell carcinoma. The approval of the fruquintinib and sintilimab combination underscores its potential to address the pressing medical needs of patients.

    60% confidence

  • The approval is a significant milestone for patients with advanced RCC in China, further validates the sintilimab plus fruquintinib combination regimen now approved for two difficult-to-treat cancers, and represents the 10th approved indication for sintilimab (TYVYT®).

    60% confidence

  • This approval reaffirms HUTCHMED's deep commitment to delivering innovative therapies to patients facing advanced renal cell carcinoma in China, where second-line treatment options remain limited. HUTCHMED is pushing the boundaries of research across monotherapies, combination strategies, and new platforms such as ATTC technology.

    60% confidence

  • The FRUSICA-2 trial results provided compelling evidence that the fruquintinib and sintilimab combination could play a meaningful role in shaping second-line treatment strategies for advanced renal cell carcinoma.

    60% confidence

  • Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy.

    60% confidence

  • Approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022, and approximately 74,000 new patients were diagnosed with kidney cancer in China in 2022. Approximately 90% of kidney tumors are renal cell carcinoma.

    60% confidence

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