Hutchmed Stock Hits Over One-Month High After China Accepts Kidney Cancer NDA Filed With Partner Innovent Biologics

Shares of Hutchmed (China) hit their highest levels in over a month after the company announced along with Innovent Biologics that their NDA for a kidney cancer treatment had been accepted by China's drug regulator.

At the close on Wednesday, Hutchmed shares rose 4.1% to $15.3, with an additional 0.5% gain to $15.38 in after-hours trading.

The China National Medical Products Administration (NMPA) accepted for review the NDA for fruquintinib combined with sintilimab as a treatment for patients with advanced renal cell carcinoma who did not respond to tyrosine kinase inhibitor therapy, according to a joint company statement.

Results of the FRUSICA-2 trial showed the drug met its primary progression-free survival goal and also improved secondary measures such as objective response rate and duration of response.

“Submitting this NDA...marks an important step in our efforts to address this unmet need,” said Michael Shi, head of R&D and chief medical officer at Hutchmed.

Hui Zhou, senior vice president at Innovent, said the filing represents the tenth indication for sintilimab, calling it a milestone in lifecycle management.

The combination therapy received conditional approval from the NMPA in December 2024 for patients with advanced mismatch repair proficient endometrial cancer.

Fruquintinib is approved in China under the brand Elunate and is marketed globally as Fruzaqla by Takeda. 

Sintilimab, co-developed by Innovent and Eli Lilly, is approved for multiple indications and included in China’s national reimbursement list.

On Stocktwits, retail sentiment was ‘neutral’ amid ‘high’ message volume.

The stock has risen 1.5% so far in 2025.

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