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    Home > Medical News > Latest Medical News > Clinical Trends of China's Class 1 New Drugs in November 2019 (Part 1)

    Clinical Trends of China's Class 1 New Drugs in November 2019 (Part 1)

    • Last Update: 2020-06-19
    • Source: Internet
    • Author: User
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    In November 2019, a total of 9 Chinese class 1 Chemicals obtained the implied permission of clinical trials from the National Drug Administration (nmpa, formerly CFDA)The specific information is shown in the table below: < br / > 01 < br / > jacktinib hydrochloride < br / > jacktinib hydrochloride is a selective JAK inhibitor developed by Zejing pharmaceuticalAt present, the highest stage is in clinical phase II, which is used to treat alopecia areata and myelofibrosis, It includes PMF, ppv-mf or pet-mfThe drug is still in the first phase of clinical trials to treat cancer< br / > in August 2019, Zejing pharmaceutical again submitted the clinical trial application (chemical medicine class 1) to the National Drug Administration (nmpa, the former CFDA)In November 2019, the implied permission of clinical trial was obtained for the treatment of severe alopecia areata< br / > R & D milestone < br / > in November 2018, the clinical phase II trial to evaluate the safety and effectiveness of the treatment of myelofibrosis started in China (nct03886415)In September 2017, a randomized, double-blind, incremental dose tolerance, pharmacokinetics, and food impact phase I study (ctr20170573) of single and multiple oral administration of cetinib hydrochloride or placebo tablets began in ChinaIn April 2016, Suzhou Zejing biopharmaceutical Co., Ltdand Shanghai Zejing Pharmaceutical Technology Co., Ltdsubmitted the clinical trial application (chemical medicine class 1) to CFDA, and obtained the clinical trial approval document in December 2016, with the approval number of 2016l10574 (0.1g specification) and 2016l10575 (50mg specification), and was approved to enter phase I / II / III clinical research< br / > 02 < br / > gst-hg141 tablets < br / > gst-hg141 were developed by Fujian guangshengtang Pharmaceutical Co., LtdIn August 2019, Fujian guangshengtang submitted the clinical trial application (chemical class 1) of the product to the National Drug Administration (nmpa, formerly CFDA)In November 2019, it obtained the implied permission of clinical trial and was intended to be used for the treatment of chronic hepatitis B< br / > 03 < br / > hif-117 capsule < br / > hif-117 was developed by Shenyang Sansheng Pharmaceutical Co., Ltdand submitted clinical trial application (chemical class 1) to nmpa (former CFDA) in August 2019In November 2019, the implied permission of clinical trial was obtained for the treatment of anemia in patients with chronic kidney disease < br / > hif-117 is a small molecule selective inhibitor of hypoxia inducible factor proline hydroxylase (HIF PHS) By inhibiting HIF PHS, hif-117 can improve the stability and half-life of hif-α, thus promoting the secretion of erythropoietin (EPO) in kidney and other non renal organs (such as liver), and up regulating the level of EPO receptor in bone marrow At the same time, HIF PHS inhibitors can also promote the absorption of iron in the intestine, mobilize iron transport to the bone marrow, stimulate the generation of red blood cells in the bone marrow, and improve the concentration of hemoglobin, so as to achieve the therapeutic effect on anemia in patients with chronic kidney disease < br / > the current Chinese class 1 drugs targeting HIF PHS are shown in the following table: < br / > 04 < br / > emdifen tablets < br / > emdifen was developed by HongRi pharmaceutical industry and Institute of pharmaceutical research, Chinese Academy of Medical Sciences In August 2019, the application for clinical trials (chemical class 1) was submitted to the National Drug Administration (nmpa, formerly CFDA) In November 2019, it obtained the implied permission of clinical trials for the treatment of solid tumors Emdifen is an oral small molecule inhibitor of PD-L1 At present, no small molecule drug with the same target has been approved for marketing at home and abroad < br / > 05 < br / > bpi-1178 capsule < br / > bpi-1178 was developed by Shanghai bereda Pharmaceutical Co., Ltd and its subsidiary bereda Pharmaceutical (Suzhou) Co., Ltd submitted the clinical trial application (chemical medicine class 1) to nmpa (former CFDA) in August 2019 Obtained the implied permission of clinical trial in November 2019 The adult patients with hormone receptor (HR) positive / human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer were selected as the first developed indications During the clinical research and development process, the indications of other advanced breast cancer species were further developed according to the clinical research results of bpi-1178 and similar drugs < br / > 06 < br / > tnp-2092 capsule < br / > tnp-2092 was developed by Dano medicine It is a multi-target coupling molecule It can inhibit RNA polymerase, DNA helicase and topoisomerase IV three important targets to achieve bactericidal effect, with stronger bactericidal activity and lower drug resistance frequency Tnp-2092 is currently in the second phase of clinical research on bacterial infection (in the United States), and the first phase of clinical research on chronic gastritis, gastric ulcer and gastric cancer caused by Helicobacter pylori infection The compound was originally developed by Cumbre, which was declared bankrupt in April 2009 and acquired by Dano pharmaceutical In September 2019, Dano pharmaceutical submitted a clinical trial application (chemical medicine class 1) to the National Drug Administration (nmpa, formerly CFDA) In November 2019, it obtained the implied permission of clinical trial for the treatment of hepatocirrhosis hyperglycemia and hepatic encephalopathy < br / > 07 < br / > ddci-01 capsule < br / > ddci-01 is a pde5a inhibitor developed by Chongqing University of Arts and Sciences, which is used to treat erectile dysfunction and pulmonary hypertension In May 2019, Chongqing dikangerle Pharmaceutical Co., Ltd signed a school enterprise cooperation agreement with Chongqing University of Arts and science In September 2019, Chongqing dikangerle submitted the clinical trial application (chemical medicine class 1) to the National Drug Administration (nmpa, formerly CFDA) In November 2019, it obtained the implied permission of clinical trial and was intended to be used for the treatment of pulmonary hypertension < br / > the current Chinese class 1 drugs targeting pde5a are shown in the following table: < br / > 08 < br / > apg-1387 for injection < br / > apg-1387 is a high-efficiency and specific inhibitor of apoptosis protein (IAP) developed by AXA, which mainly promotes the process of apoptosis by blocking the activity of IAPs, At present, the first / second phase clinical trials for the treatment of advanced solid tumors and hematological malignancies and the first phase clinical trials for the treatment of colorectal cancer and hepatitis B are under way In September 2019, Jiangsu Yasheng Pharmaceutical Development Co., Ltd submitted a clinical trial application (chemical medicine class 1) to the National Drug Administration (nmpa, formerly CFDA) In November 2019, tacit permission of clinical trial was obtained for the treatment of advanced solid tumor with treprizumab < br / > R & D milestone < br / > in April 2019, apg-1387 will be used in combination with the anti PD-1 mAb trepril mAb of Junshi biology for the treatment of solid tumor / hematoma (especially refractory and drug resistant tumor) and other indications In January 2018, the study of the drug on HBV was in phase I clinical stage By October 2018, the multicenter, open and dose increasing phase I clinical study (ctr20180218) assessing the safety, tolerance, pharmacokinetics and pharmacodynamics of apg-1387 in patients with chronic hepatitis B was still in progress (not yet recruited) In December 2017, an open label single group clinical phase I / II trial (nct03386526) was initiated in patients with advanced solid or malignant tumors in the United States In November 2017, it is planned to launch an open, multicenter, stage IB clinical study (ctr20170890) of apg-1387 combined with irinotecan in the treatment of patients with locally advanced or metastatic colorectal cancer who have progressed after at least one chemotherapy In November 2017, the ind application submitted in the United States was accepted by FDA In February 2017, Jiangsu Yasheng pharmaceutical and Guangzhou Shunjian Biology (Yasheng pharmaceutical holding) submitted their clinical application again, and were approved to carry out clinical research on HBV in January 2018 In April 2015, the open dose phase I clinical trial of apg-1387 in the treatment of advanced solid tumor patients (ctr2015, 2016) began in China, and the clinical results were announced at the 2018 ASCO meeting In March 2014, a multicenter dose escalation trial (anzctr365304) was initiated in advanced cancer patients in Australia In June 2013, Jiangsu Yasheng pharmaceutical submitted ind in China and was approved in November 2014 < br / > 09 < br / > act001 capsule < br / > act001 is a kind of micheliolide derivative targeting STAT3 and NF - κ B, which is jointly developed by Tianjin Shangde pharmaceutical science and technology and Nankai University At present, it is in the first stage of clinical research and development in the treatment of glioblastoma and acute myeloid leukemia and the first stage of clinical I / IIA in the treatment of optic neurmyelitis Tianjin Xinyi Shangde Biomedical Technology Co., Ltd., a subsidiary of Tianjin Shangde pharmaceutical edge technology Co., Ltd., submitted the clinical trial application (chemical medicine class 1) of the product to the State Drug Administration in September 2019 In November 2019, we obtained the implied permission of clinical trials for the treatment of solid tumors in children < br / > 2 < br / > general situation of clinical approval of class 1 biological drugs < br / > in November 2019, a total of 10 Chinese class 1 therapeutic biological products obtained the implied permission of clinical trials from the National Drug Administration (nmpa), and the specific information is shown in the table below: < br / > 01 < br / > T-cell injection of anti-CD19 chimeric antigen receptor < br / > T-cell therapy of anti-CD19 chimeric antigen receptor was developed by synbiotics In November 2018, the application for clinical trial (therapeutic biological product class 1) was submitted to the National Drug Administration (nmpa, former CFDA) and was approved for clinical trial in November 2019 for the treatment of recurrent or refractory invasive non-Hodgkin B-cell lymphoma < br / > the current Chinese class 1 drugs targeting CD19 are shown in the table below: < br / > 02 < br / > sk08 live bacterial powder < br / > sk08 live bacterial powder is an innovative biological drug developed by Guangzhou Zhiyi Biotechnology Co., Ltd and a new generation of living probiotics In November 2018, the National Drug Administration (nmpa, the former CFDA) accepted the clinical trial application of this product (Class 1 biological products for treatment) In November 2019, clinical trials were approved for the treatment of irritable bowel syndrome and ulcerative colitis < br / > 03 < br / > si-b001 bispecific antibody injection < br / > si-b001 is an anti EGFR and HER3 bispecific antibody developed by systimune (a subsidiary of Sichuan Baili) It is the first clinical EGFR and HER3 bispecific antibody approved in the world In August 20ddc19, Sichuan Baili submitted the clinical trial application (Class 1 biological products for treatment) to the National Drug Administration (nmpa) In November 2019, it obtained the implied permission of clinical trials for the treatment of locally advanced or metastatic epithelial tumors, including esophageal squamous cell carcinoma, lung squamous cell carcinoma, Sanyin breast cancer, head and neck squamous cell carcinoma, colorectal cancer, etc < br / > 04 < br / > as1501 for injection < br / > as1501, developed by Shenzhen Zhongke Aishen Pharmaceutical Co., Ltd., is a tumor necrosis factor related apoptosis inducing ligand (TRAIL) blocker In August 2019, nmpa (the former CFDA) accepted the clinical trial application of this product (Class 1 biological products for treatment) In November 2019, the implied permission of clinical trial was obtained for liver injury and / or liver failure caused by viral, autoimmune and drug-induced hepatitis < br / > 05 < br / > shr-1802 for injection < br / > shr-1802 is a monoclonal antibody targeting lymphocyte activating gene 3 protein (Lag3) developed by Jiangsu Hengrui, Shanghai Hengrui and Suzhou shengdia Lag3 is an immunosuppressive molecule, which is expressed in activated T lymphocytes, NK cells, B lymphocytes and dendritic cells, and has the effect of inhibiting the immune function of T cells < br / > in August 2019, Suzhou shengdia, Shanghai Hengrui and Jiangsu Hengrui submitted the clinical trial application (treatment biological products class 1) to the National Drug Administration (nmpa, formerly CFDA) In November 2019, tacit permission for clinical trials was obtained for the treatment of advanced malignant tumors that failed in standard treatment < br / > the current Chinese class 1 drugs targeting at Lag3 are shown in the table below: < br / > 06 < br / > imm0306 for injection < br / > imm-0306 is a kind of bispecific antibody targeting at CD20 and CD47 developed by yimingongke company, which plays the role of targeting tumor by activating macrophages In August 2019, the ind application of the drug (therapeutic biological products class I) was undertaken by the National Drug Administration (nmpa, formerly CFDA), and in November 2019, the implied permission of clinical trial was obtained to treat refractory or recurrent CD20 positive non Hodgkin B cells
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