Hehuang pharmaceutical announced that sofantini was certified as an orphan drug by FDA

November 26, 2019 / Meitong news agency / -- and Huang China Pharmaceutical Technology Co., Ltd (aim / NASDAQ: HCM for short) announced today that sofantini has been granted orphan drug qualification by the US Food and Drug Administration ("FDA") for the treatment of pancreatic neuroendocrine tumor ("net") "There are still many unmet needs in the treatment of neuroendocrine tumors," said Christian Hogg, chief executive of Hewang pharmaceutical The current treatment is very limited It is a positive step for patients to obtain the qualification of orphan drugs granted by FDA, and further emphasizes the importance of our research and development work, so as to bring sofantini to more patients in need " If the qualification of orphan drug is approved by FDA, suvantinib will obtain the market monopoly right for 7 years Orphan drug qualification can also bring certain development costs and benefits in the United States Sofantini is currently being studied in China and the United States as a single drug therapy or in combination with other tumor immunotherapies for a variety of solid tumors Sofantini is the second innovative tumor drug independently developed and successfully completed phase III clinical trials by Hehuang pharmaceutical Suvantinib's new drug application for advanced non pancreatic net has been submitted and accepted by China National Drug Administration (nmpa) on November 11, 2019 In terms of FDA orphan drug qualification, obtaining the FDA orphan drug qualification means that the drug or biological preparation provides safe and effective treatment, diagnosis or prevention for diseases or diseases with less than 200000 patients in the United States For some drugs, if the number of people suffering from the disease exceeds 200000, but the development and sales costs are not expected to be recovered, orphan drug qualification can also be obtained Sufatinib (hmpl-012 or sulfatinib) is a new oral tyrosine kinase inhibitor independently developed by Hehuang pharmaceutical, which has dual activities of antiangiogenesis and immunoregulation Sufentanil can block tumor angiogenesis by inhibiting vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), inhibit colony stimulating factor-1 receptor (CSF-1R), and promote immune response to tumor cells by regulating tumor related macrophages Because of its dual mechanism of anti-tumor angiogenesis and immune regulation, suvantinib may be very suitable for combination with other immunotherapies At present, sofantini is carrying out a number of concept validation studies in the United States, and a number of later clinical trials and concept validation studies in China According to Frost & Sullivan, China's market for anti angiogenic vascular endothelial growth factor receptor (VEGF / VEGFR) inhibitors has grown from $500 million in 2015 to more than $1.5 billion in 2019, and is expected to reach $5 billion by 2026 Hehuang pharmaceutical currently has all the rights of sofantini in the world China's non pancreatic neuroendocrine tumor research: in 2015, Hewang pharmaceutical launched the sanet EP research, which is a phase III clinical trial of suvantinib for the indication of advanced non pancreatic neuroendocrine tumor in China, but there is no effective treatment for these patients at present In June 2019, the independent data monitoring committee (IDMC) of the study assessed that a total of 198 patients in the mid-term analysis successfully reached the primary efficacy end point of progression free survival (PFS) and terminated the study ahead of schedule Chinese pancreatic neuroendocrine tumor research: in 2016, Hehuang pharmaceutical 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 end point was progression free survival Hehuang pharmaceutical plans to carry out a mid-term analysis in the first half of 2020, and complete the group work of patients in 2020 (clinical trials Gov Registration No nct02589821) Neuroendocrine tumor research in the United States and Europe: Hehuang pharmaceutical plans to carry out the registration study of sofantini in neuroendocrine tumor patients in the United States The data of phase II and phase III Chinese clinical trials with neuroendocrine tumor as indication of sofantini is encouraging (clinical trials Gov Registration No nct02267967), and the progress of phase IB clinical trials in the United States is smooth (clinical trials Gov Registration No nct02549937) China bile duct cancer research: in March 2019, a phase IIb / III clinical trial was launched with Huang Pharma 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 (clinicaltrials.gov registration number nct03873532) Immunocombination therapy: in November 2018 and September 2019, several cooperation agreements were reached with Huang Pharma to evaluate the safety, tolerance and efficacy of suvantinib combined with PD-1 monoclonal antibody It includes the cooperation agreement with Shanghai Junshi Biomedical Technology Co., Ltd to jointly develop suofentini and tuoyi combined therapy in the world, and the cooperation agreement with Cinda biopharmaceuticals to jointly develop dabershu combined therapy in the world Both tuoyi and dabushu have been approved in China 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 67600 newly diagnosed cases of neuroendocrine tumors in 2018 According to China's incidence rate and prevalence ratio (incidence to prevalence ratio), China has a total of 300000 patients with neuroendocrine tumor [1] It is estimated that about 80% of Chinese patients with neuroendocrine tumors are non pancreatic neuroendocrine tumors About Hehuang pharmaceutical and Huang China Pharmaceutical Technology Co., Ltd (hereinafter referred to as "Hehuang pharmaceutical" or "Chi Med") (aim / NASDAQ: HCM) is an innovative biomedical company dedicated to the research, development, production and sales of drugs Hutchison Whampoa Pharmaceutical (Shanghai) Co., Ltd is the innovative drug R & D platform of Hutchison pharmaceutical It has a R & D team of about 470 people, which focuses on R & D and commercial development of targeted innovative drugs and immunotherapy for cancer and autoimmune diseases At present, there are eight anti-cancer candidate drugs entering the clinical stage, and clinical research is being carried out globally Hehuang pharmaceutical's business platform is responsible for the production and marketing of prescription drugs and health consumer goods in China, and its sales network covers a large number of regional hospitals in China Hehuang pharmaceutical, headquartered in Hong Kong, China, is listed on the London Stock Exchange (AIM) and NASDAQ Global Select markets Reference: [1] according to the data of Frost & Sullivan company, in 2018, the number of newly diagnosed cases of neuroendocrine tumors in the United States was 19000, and the total number of neuroendocrine tumor patients in the United States was about 141000 In China, the incidence rate of neuroendocrine tumors is estimated to be 4.4, which is lower than that of the US 7.4 37