(Alliance News) - Hutchmed China Ltd on Tuesday reported it was granted conditional approval in China for an injection to treat endometrial cancer.
The Hong Kong-based pharmaceutical company jointly announced the news with Innovent Biologics Inc, its China-based drug development partner. The decision marks the first regulatory approval for an injection combining the chemical fruquintinib with the immune checkpoint inhibitor TYVYT.
Hutchmed China's Elunate formula contains fruquintinib, while Innovent developed the Sintilimab injection with TYVYT. The combined formula has been approved for use in patients with advanced endometrial cancer who are not suitable for curative surgery or radiation, and whose tumours have failed prior systemic therapy.
In June, the American Society of Clinical Oncology reviewed studies of the injection's use in patients with aggressive and persistent cancer. It showed "rapid on-set efficacy" and adverse side effects consistent with existing treatments, Hutchmed China said.
One of the researchers affliated with the study, Professor Xiaohua Wu, directs the Department of Gynecologic Oncology at Fudan University Affiliated Cancer Hospital. Wu commented: "This approval of fruquintinib plus sintilimab could represent a paradigm shift".
The chemical combination was designated a "breakthrough therapy" by China's National Medical Products Administration in July 2023, suggesting it was a significant improvement on previous treatment options.
Michael Shi, Hutchmed China's chief medical officer, said the company was eager to make the injection available as soon as possible, though a predicted date for first use has not been specified.
Hutchmed China said it had planned a third-phase confirmatory study of the fruquintinib and sintilimab combination.
Hutchmed China shares were down 2.9% at 272.00 pence each on Tuesday afternoon in London.
By Holly Munks, Alliance News reporter
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