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Content Source: Pharmaceutical Rubik's Cube Info Recently, Hutchison Whampoa Pharmaceuticals Class 1 new drug Sovantini capsule (acceptance number: CXHS1900034) in the domestic listing application into the "in the approval" stage, is expected to be approved by NMPA in the near future.
is intended to be marketed as the treatment of advanced non-pancreatic neuroendocrine tumors.
Sovantini's application for listing is based on successful Phase III SANET-ep clinical research data.
the difference between daily oral sovantinib and placebo in patients with low- and medium-level advanced non-pancreatic neuroendocrine tumors who did not have effective treatment.
84 percent of the patients who participated in the study were grade 2 lesions, and 41 percent had diseases that originated outside the gastrointestinal tract and lungs or had unknown origins.
the researchers assessed that the middle PFS in the Sovantinie treatment group was 9.2 months, compared with 3.8 months in the placebo group (HR=0.334; 95% CI: 0.223-0.499; p.lt;0.0001), Sovantini reduces the risk of disease progress or death by 67%.
The therapeutic efficacy of Sovantinie was observed in all subgroups, and these therapeutic outcomes were supported by statistical data that included significant improvements in secondary efficacy endpoint indicators such as objective remission rate (ORR), disease control rate (DCR), time to disease remission (TTR), and duration of remission (DoR).
study, Sovantinistinie was generally well-to-do and had safety characteristics consistent with previous clinical trials.
is a new oral tyrosine kinase inhibitor independently developed by He huang Medicine, which has the dual activity of anti-angiogenesty and immunomodulation.
Sovantinib blocks tumor angiogenesic production by inhibiting vascular endotranspheric growth factor subjects (VEGFR) and fibroblast growth factor subjects (FGFRs) and inhibits the set-up stimulation factor-1 subject (CSF-1R), which promotes the body's immune response to tumor cells by regulating tumor-related macrophages.
china's VEGF/VEGFR inhibitor market has grown from $500 million in 2015 to more than $1.5 billion in 2019 and is expected to reach $5 billion in 2026, according to Frost and Sullivan.
neuroendocrine tumor (NET) originated in cells that interact with the nervous system or in hormone-producing glands.
neuroendocrine tumors can originate in many parts of the body, most commonly in the digestive tract or lungs, can be benign or malignant tumors.
, neuroendocrine tumors are usually divided into pancreatic neuroendocrine tumors and non-pancreatic neuroendocrine tumors.
approved targeted treatments include Sotan ® (shonithini) and finito ® (Ivemos), which are used to treat pancreatic neuroendocrine tumors or highly differentiated non-functional gastrointestinal or pulmonary neuroendocrine tumors.
, there were about 67,600 new diagnoses of neuroendocrine tumors in 2018.
estimated to be as high as 300,000 cases of neuroendocrine tumors in China, based on the ratio of morbidity to prevalence.
estimates that about 80% of patients with neuroendocrine tumors in China are non-pancreatic neuroendocrine tumors.
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