And Huang China Pharmaceutical Technology Co., Ltd. ("and Huang Medicine" or "Chi-Med") recently announced that Sovantini (Chinese trade name: Sutaida ®) has been officially approved by China's State Drug Administration (NMPA) for the treatment of non-pancreatic neuroendocrine tumors (NET).
will be sold in the Chinese market under the ® Sulanda, a ® brand.
It is worth mentioning that Sofantini is the first independent research and development of innovative oncology drug approved by Huang Pharmaceuticals in China, following the approval of the first innovative oncology drug in 2018, Ayutthini capsules®, and the second cancer drug approved by Huang Pharmaceuticals in China.
, there are an estimated 67,600 new diagnoses of neuroendocrine tumors in 2018.
estimated that there may be up to 300,000 cases of neuroendocrine tumors in China, based on the ratio of incidence to prevalence.
And Huang Medicine has established a commercial team of about 400 oncologists and now covers more than 2,000 hospitals across the country.
team is led by a leadership team with extensive experience in the commercialization of cancer products in China and in the field of neuroendocrine tumors.
this approval, based on the results of a Chinese Phase III clinical trial SANET-ep for the treatment of patients with advanced non-pancreatic neuroendocrine tumors (clinicaltrials.gov registration number NCT02588170).
the study successfully reached the predetermed primary endpoint of progress-free lifetime (PFS) in a preset medium-term analysis.
results showed that sovantinib reduced the risk of disease progression or death by 67%, the medium PFS in patients treated with sovantinib was significantly extended to 9.2 months, and the placebo group was 3.8 months (Risk ratio of 0.334;95% confidence interval of .223-0.499; p.lt;0.0001).
have acceptable safety characteristics, the most common level 3 or above treatment-related adverse events are hypertension (Sovantinie group patients: 36%; Placebo group patients: 13%), proteinuria (Sofantini group patients: 19%; Placebo group patients: 0%) and anemia (Sovantinib group patients: 5%; Placebo group patients: 3%).
surufatinib chemical structure (Photo: pubchem) Surufatinib is a new oral tyrosine kinase inhibitor developed by He huang Medicine, with anti-angiogenesic and immunomodulation dual activities.
Sovantinib blocks tumor angiogenesic production by inhibiting endotranotrogen (VEGFR) and fibroblast growth factor subjects (FGFR) and inhibits the collection stimulation factor 1 subject (CSF-1R), which promotes the body's immune response to tumor cells by regulating tumor-related macrophages.
's unique dual mechanism produces synergetic anti-tumor activity, making it ideal for use in combination with other immunotherapies.
and Yellow Medicine currently have all the rights of Sovantini on a global scale.
recently, and Yellow Pharmaceuticals announced that it had begun rolling the first part of a new drug listing application (NDA) for Sovantinib for the treatment of pancreatic and non-pancreatic neuroendocrine tumors (NET).
the company plans to complete the filing of new drug listing applications in the first half of 2021, which will be the first U.S. new drug listing application for He huang Pharmaceuticals.
previously, the FDA granted Sovantinie two fast-track qualifications in April 2020 for the treatment of pancreatic and non-pancreatic neuroendocrine tumors, and an orphan drug in November 2019 for the treatment of pancreatic neuroendocrine tumors.