Hutchison China MediTech (Chi-Med) announced that surufatinib has been granted approval for drug registration by the National Medical Products Administration of China (NMPA) for the treatment of non-pancreatic neuroendocrine tumors (NETs). Surufatinib will be marketed in China under the brand name Sulanda. Surufatinib is Chi-Med’s first self-discovered oncology drug to be approved in China without the support of a development partner, and follows the approval of Chi-Med’s first oncology drug, Elunate (fruquintinib capsules), in 2018.
Christian Hogg, chief executive officer of Chi-Med commented, “We are very pleased to have achieved this major milestone for Chi-Med. The approval of surufatinib, our first un-partnered oncology drug, is a strong testament to our in-house research and development capability.”
“Today’s approval also marks an important development for NET patients, for whom there are currently limited treatment options. Compared with other NET therapies available in the market, surufatinib has a unique mode of action by both inhibiting angiogenesis and promoting the body’s immune response against tumor cells. If our second new drug application (NDA) in pancreatic NET is successful, this therapy would be approved in China to address all NET patients regardless of the tumor origin.”
“We look forward to making this unique therapy available to patients as quickly and broadly as possible through our own expanded oncology commercial team.”
Chi-Med has established an oncology commercial team that today covers more than 2,000 hospitals across China. The team is led by a leadership team highly experienced in oncology products commercialization in China with deep knowhow in the field of NETs.
The NMPA approval of Sulanda was based on results from the SANET-ep1 study, a phase III trial in patients with advanced non-pancreatic NETs conducted in China. The study met the pre-defined primary endpoint of progression-free survival (PFS) at a preplanned interim analysis. The positive results of this trial were highlighted in an oral presentation at the 2019 ESMO Congress) and published in The Lancet Oncology in September 2020. Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment-related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).
In China, there were an estimated 67,600 newly diagnosed NET patients in 2018. Considering the current incidence to prevalence ratio, there may be as many as 300,000 patients living with the disease.
NETs form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NETs are typically classified as pancreatic NET (pNET) or non-pancreatic NET (epNET). Approved targeted therapies include Sutent (for pNET only) and Afinitor for pNET and well-differentiated, non-functional gastrointestinal or lung NET.
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.