Sovantini was awarded two fast-track qualifications by the FDA

On April 17, He huang China Pharmaceutical Technology Co., Ltd. (Chi-Med, called and Huang Pharmaceuticals) announced that its oral tyrosine kinase inhibitor surufatinib has been awarded two fast-track qualifications by the FDA for the treatment of patients with late-stage and incarnate endocrine tumors (NET) and non-pancreatic NETs that are not suitable for surgery. This is another important step forward in the development of the drug overseas, following the FDA's fda-granted orphan drug for treatment of pancreatic neuroendocrine tumors (NET) last November.Sovantini is a small molecule oral tyrosine kinase inhibitor, which acts by blocking tumor angiogenesic production by inhibiting endotranskin growth factor subjects (VEGFR) and fibroblast growth factor bodies (FGFRs), 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. At the same time, because the drug has a dual mechanism of anti-tumor angiogenesic and immunomodulation, it may be well suited for use in combination with other immunotherapies.And Yellow Pharma currently owns all of Sofantini's rights worldwide. Sovantini is currently conducting research on multiple solid tumors in China and the United States as a single-drug treatment or in combination with other tumor immunotherapy therapies. Current clinical studies in China, the United States and Europe include:U.S. and European neuroendocrine tumor studies: and yellow medicine programs in the United States to conduct sovantini in patients with neuroendocrine tumors registered research. Due to the encouraging data of Phase 2 and Phase 3 Clinical Trials in China with Neuroendocrine Tumors, and the progress of Phase 1b clinical trials in the United States.China Non-Pancreatic Neuroendocrine Tumor Research: In 2015, And Huang Pharmaceuticals launched the SANET-ep study, a Phase 3 clinical trial in China in which Sovantini is adapted to advanced non-pancreatic neuroendocrine tumors, which was announced in June 2019 to reach the primary therapeutic endpoint and terminate the study early. On November 11, 2019, He Huang Pharmaceuticals announced that The application for the listing of a new drug for the treatment of advanced non-pancreatic neuroendocrine tumors (NDA) has been accepted by China's State Drug Administration. The application is based on KEY Phase 3 clinical research data from SANET-ep.The results showed that Soventinistinist reduced the progress or mortality of the disease by 67 per cent and was generally well-to-bear. According to the researchers' assessment, the middle PFS was 9.2 months for patients in the Sovantinie treatment group, compared with 3.8 months for patients in the placebo group. The therapeutic efficacy of Sovantinie was observed in all subgroups, and these therapeutic efficacy was 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).China Pancreatic Neuroendocrine Tumor Research: In 2016, And Huang Pharmaceuticals launched a key Phase 3 registered study in China, SANET-p, in patients with low- or medium-level advanced pancreatic neuroendocrine tumors. And Huang Pharmaceuticals plans to conduct a mid-term analysis in the first half of 2020 and complete the patient group by 2020.China Bilionic Cancer Research: In March 2019, And Huang Pharmaceuticals launched a Phase 2b/3 clinical trial aimed at the efficacy and safety of the treatment of patients with advanced bilionic cancer who failed first-line chemotherapy in Bile Dubin and Carpentinib. The main endpoint of the study is OS).Immuno combination therapy: In November 2018 and September 2019, several cooperation agreements were reached with Yellow Pharmaceuticals to assess the safety, toerability and efficacy of sovantinie combined PD-1 monoantigen. Since 2018, several cooperation agreements have been reached with Huang Pharmaceuticals and Companies such as Cynda Bio and Junshi Bio to assess the efficacy and safety of Sovantinie's combined PD-1 antibodies.Neuroendocrine tumors (NET) are usually divided into pancreatic neuroendocrine tumors and non-pancreatic neuroendocrine tumors. Compared with other tumors, neuroendocrine tumor patients have a relatively long survival period, although the incidence rate is relatively low, but the patient population is larger. According to an earlier and yellow medicine press release, there were about 141,000 neuroendocrine tumor patients in the United States in 2018, of whom more than nine were non-pancreatic neuroendocrine tumor patients. In China, there will be about 676,000 newly diagnosed cases of neuroendocrine tumors in 2018, and an estimated 300,000 neuroendocrine tumor patients in China, about 80% of whom will be non-pancreatic neuroendocrine tumor patients. There is currently no effective treatment for these patients.Fast Track eligibility is one of several drug acceleration programs used by the FDA to accelerate the development and review of potential drugs for serious illnesses and to meet unfinished medical needs. Fast-track programs are eligible for more frequent interactions with the FDA on drug development programs. (
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