Hwang China announced that the main end point of sanet EP interim analysis was reached and will be terminated in advance

June 14, 2019 / American news agency / -- and Huang China Pharmaceutical Technology Co., Ltd (chi MED) (aim / NASDAQ: HCM) announced on June 14 that the mid-term analysis of sanet EP pre-set, a phase III critical study with advanced non pancreatic neuroendocrine tumor as indication, has been completed by IDMC The study has successfully reached the primary efficacy end point of progression free survival (PFS), so IDMC decided to terminate the study in advance Hehuang China Pharmaceutical Science and technology will hold a meeting with China National Drug Administration (nmpa) before submitting the new drug listing application (NDA) to further discuss the preparation of sufantinib's new drug listing application for this indication, and plan to submit the research results of sanet EP at the recent academic meeting Sanet EP is a phase III clinical trial in China The enrolled population is low-grade or middle-grade advanced non pancreatic neuroendocrine tumor patients who have not been effectively treated at present In this study, patients were randomized to receive 300 mg of sufentanil or placebo once a day in a 2:1 ratio for a 28 day treatment cycle The primary endpoint of the study was PFS, and the secondary endpoints included objective response rate (ORR), disease control rate (DCR), time to remission (TTR), duration of remission (DOR), overall survival (OS), safety and tolerance Details of the study can be found at clinicaltrials.gov and can be found at nct02588170 Neuroendocrine tumors neuroendocrine tumors (net) originate from cells that interact with the nervous system or glands that produce hormones Neuroendocrine tumors can originate in many parts of the body, most commonly in the digestive tract or lungs, and can be benign or malignant tumors According to the origin, neuroendocrine tumors are usually divided into pancreatic neuroendocrine tumors and non pancreatic neuroendocrine tumors Approved targeted therapies include sotan ® (sunitinib malate) and phenytol ® (Everest) for the treatment of pancreatic neuroendocrine tumors or highly differentiated non functional gastrointestinal or pulmonary neuroendocrine tumors Frost & Sullivan estimates that 19000 new cases of neuroendocrine tumors were diagnosed in the United States in 2018 It is noteworthy that compared with other tumors, the survival time of neuroendocrine tumor patients is relatively long Therefore, although the incidence rate of neuroendocrine tumors is relatively low, the patients are relatively large In addition, it is estimated that in 2018, there will be about 141000 neuroendocrine tumor patients in the United States, of which more than 90%, or 132000, are non pancreatic neuroendocrine tumor patients In China, there are about 65600 newly diagnosed cases of neuroendocrine tumors in 2018 According to the incidence rate and prevalence ratio (incidencetoprevalenceratio) of the United States, there are up to 490000 neuroendocrine tumors in China About sofantini Soventinib (also known as hmpl-012) is a new oral anti angiogenic immune escape kinase inhibitor It can inhibit angiogenesis by inhibiting vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR) Soventinib can also inhibit colony stimulating factor-1 receptor (CSF-1R), and regulate tumor related macrophages by inhibiting CSF-1R To promote the immune response of the body to tumor cells Because of its mechanism of inhibiting tumor angiogenesis and immune escape at the same time, sofantini may be very suitable for combination with other immunotherapies Sofantini is currently conducting a number of proof of concept studies in the United States and China, and a number of later clinical trials are being conducted in China We currently have all of sofantini's rights worldwide Chinese pancreatic neuroendocrine tumor research: in 2016, Hwang China Pharmaceutical Technology launched a key phase III Registration study sanet-p in China The enrolled patients were low-level or middle-level advanced pancreatic neuroendocrine tumor patients The primary endpoint was PFS Hehuang China pharmaceutical technology plans to carry out a mid-term analysis by the end of 2019 and complete the group work of patients by 2020 (clinical trials.gov Registration No nct02589821) Research on pancreatic neuroendocrine tumor in the United States and Europe: as the data of phase II Chinese clinical trial of sofantini with pancreatic net as the indication is encouraging (clinical trials Gov Registration No nct02267967), and the progress of phase Ib / II clinical trial in the United States is smooth, and Huang Zhonghua pharmaceutical science and technology decided to carry out the registration study of sofantini in patients with pancreatic neuroendocrine tumor China bile duct cancer research: in March 2019, a phase IIb / III clinical trial was launched with Huang Zhonghua pharmaceutical technology, aiming to compare the efficacy and safety of suvantinib and capecitabine in the treatment of patients with advanced bile duct cancer who failed in the first-line chemotherapy The primary end point of the study was OS (clinical trials Gov Registration No nct03873532) immunocombination therapy: in November 2018, several cooperation agreements were reached with Huang Zhonghua pharmaceutical technology to evaluate the safety, tolerance and efficacy of suvantinib combined immunocheckpoint inhibitors This includes a cooperation agreement with Shanghai Junshi Biomedical Technology Co., Ltd to jointly develop suofentini and tuoyi ® combination therapy in the world Tuoyi ® is a PD-1 monoclonal antibody developed by Shanghai Junshi Biomedical Technology Co., Ltd., which was approved in China at the end of 2018 About Chi Med and Chi MED (aim / NASDAQ: HCM) is an innovative biomedical company dedicated to the research, development, production and marketing of drugs Hutchison Whampoa Pharmaceutical (Shanghai) Co., Ltd is an innovative drug R & D platform of Chi Med, with a R & D team of about 420 people, which focuses on R & D and commercial development of targeted innovative drugs and immunotherapy for cancer and autoimmune diseases Currently, there are eight anti-cancer candidate drugs entering the clinical stage, and clinical research is being carried out globally Chi Med's business platform is responsible for the production and marketing of prescription drugs and health consumer goods in China, with a sales network covering a large number of regional hospitals in China Headquartered in Hong Kong, China, it is listed on the London Stock Exchange (AIM) and NASDAQ Global Select market in the United States, with a majority stake held by Cheung Kong Heji Industrial Co., Ltd (SEHK: 1) This article is reprinted by yaozhi.com The copyright belongs to the original author The purpose of reprint is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please 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