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HONG KONG - HUTCHMED (China) Limited (NASDAQ/AIM:HCM; HKEX:13) and Innovent Biologics, Inc. (HKEX:01801) have announced the acceptance of a New Drug Application (NDA) by the China National Medical (TASE:BLWV) Products Administration (NMPA) for a combination therapy of fruquintinib and sintilimab. This therapy is aimed at treating advanced renal cell carcinoma in patients who have not responded to prior tyrosine kinase inhibitor therapy.
The NDA submission is based on results from the FRUSICA-2 study, which met its primary endpoint of progression-free survival. The study also reported improvements in secondary endpoints, including objective response rate and duration of response, without new safety concerns. These findings will be presented at an upcoming scientific conference, and further details are available on clinicaltrials.gov under the identifier NCT05522231.
Dr. Michael Shi, HUTCHMED’s Head of R&D and Chief Medical Officer, emphasized the importance of this development for kidney cancer patients in China, where treatment options are limited for those who fail first-line therapies. Dr. Hui Zhou, Senior Vice President of Innovent, highlighted the significance of the NDA acceptance, noting the potential of the combination therapy to become a more effective second-line treatment option.
Fruquintinib, an oral inhibitor of vascular endothelial growth factor receptors, is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company (NYSE:LLY). It has previously been approved for metastatic colorectal cancer and is included in the China National Reimbursement Drug List. Sintilimab, a PD-1 immunoglobulin G4 monoclonal antibody, has been approved for multiple indications in China and is co-developed and co-commercialized by Innovent and Eli Lilly.
The combination of fruquintinib and sintilimab has already received conditional approval in China for advanced mismatch repair proficient endometrial cancer based on the FRUSICA-1 study.
The press release statement also provided context on the prevalence of kidney cancer, with an estimated 435,000 new cases worldwide in 2022 and 74,000 in China. The information is based on a press release statement and reflects the companies’ current expectations regarding the potential therapeutic benefits of the combination therapy for advanced renal cell carcinoma.
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