China-based, globally focused healthcare group, Hutchison China MediTech (HCM) , or ‘Chi-Med’ announced on Monday that its New Drug Application for its drug, surufatinib, had been accepted for review by the China National Medical Products Administration.
Surufatinib, a novel angio-immuno kinase inhibitor, is used for treatment of patients with advanced non-pancreatic neuroendocrine tumors.
With Chi-Med currently retaining all worldwide rights to drug, surufatinib is Chi-Med’s second novel oncology drug to reach NDA submission in China — the first was fruquintinib, launched last year to address colorectal cancer under the brand name Elunate®.
"This NDA filing puts us on track for the potential approval and launch of surufatinib in China, an important development for NET patients with limited treatment options,” commented Chief Executive Officer of Chi-Med, Christian Hogg.
A recent successful study of surufatinib, the SANET-ep trial, procured data to support the NDA — this phase III study monitored patients with advanced neuroendocrine tumors, for whom there is no effective therapy.
The results were described as positive and highlighted in an oral presentation at the 2019 European Society for Medical Oncology Congress on September 29, 2019.
Mr Hogg acknowledged the company’s efforts to maximize patient access to surufatinib, an effort stregnthened by its regulatory approval. He commented:
“We are now building our own dedicated commercial oncology organization and expect to be ready to cover all relevant hospitals and clinics in China at the time of launch.”
Surufatinib is currently under investigation in multiple solid tumors in China, the U.S. and Europe, both as a monotherapy and in combination with immunotherapies.
"We believe surufatinib has robust efficacy, tolerability and combinability with a dual angio-immuno kinase inhibition profile, which may make it an attractive treatment in China," added Mr Hogg.
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