21 "China class 1" antitumor drugs under research in clinical phase III (Part I)

  Phase III clinical research is like a football match The success or failure is always at one stroke Anti-tumor drugs are the hottest direction of drug research and development at present, and are favored by numerous new drug research and development companies Therefore, those phase III clinical research drugs, which are at the intersection of the two, usually affect the heartstrings of countless new drug developers and investors in China 。 In this paper, the author searched the "China class 1" anti-tumor drugs currently in the "clinical phase III" and "in progress", hoping to give you a little inspiration in your work 21 "China class 1" antitumor drugs in clinical phase III Through drug delivery data query: in the current 13215 drug databases (data updated to March 11, 2018), 677 drugs in "clinical phase III" and "ongoing" clinical status in the R & D stage, including 49 drugs belonging to "China class 1"; among them, 21 anti-tumor drugs, the search results are as follows: The search results are from drug-related data So, what are the 21 "China class 1" anti-tumor drugs in clinical phase III? They are sabaficin hydrochloride, enrotinib hydrochloride, famitinib malic acid, recombinant human endostatin, mb-07133, dipropionate, floreplatin, vorolanib, donafinib toluenesulfonate, tyrosleutide, glufosamide, sofantini, paclitaxel, zanubrutinib, voritinib, entenote, isatidinib, alanine, recombinant human The detailed "drug name target indication R & D code R & D company" is shown in the following table: detailed explanation of the 21 anti-tumor drugs in research sabarubicin hydrochloride (sabarbicin hydrochloride) Sabaficin hydrochloride, developed by menarini, is in clinical phase II / III and is used for the treatment of small cell lung cancer In 2004, the compound obtained the orphan drug qualification granted by EMA The compound was used in clinical phase I research in China for the treatment of small cell lung cancer In October 2012, the national CFDA accepted the joint submission of Hefei Heyuan Pharmaceutical Co., Ltd and Beijing new line Pharmaceutical Technology Development Co., Ltd The clinical trial application (chemical 1.1) was approved in 2013 The details are shown in the following table: anlotib dihydrochloride (anlotinib hydrochloride) and anlotinib hydrochloride It is a new small molecule multi-target tyrosine kinase inhibitor, which can effectively inhibit VEGFR, PDGFR and FGFR , c-kit and other kinases, which have the effect of anti-tumor angiogenesis and tumor growth inhibition, are currently in clinical phase III, and are used for the treatment of metastatic colorectal cancer and advanced gastric adenocarcinoma; in addition, the research on the treatment of ovarian cancer, endometrial cancer, non-small cell lung cancer, medullary thyroid cancer, advanced soft tissue sarcoma and advanced renal cell cancer is in clinical phase III; in 2015, the compound was The product is suitable for advanced non-small cell lung cancer that has been developed or recurred after at least two kinds of systematic chemotherapy, and EGFR In July 2010, Zhengda Tianqing Pharmaceutical Co., Ltd submitted a clinical trial application (chemical class 1) to China's CFDA, and obtained the clinical trial approval document in April 2011 Currently, phase III clinical trials are carried out in China, and the details are shown in the table below: Famitinibmalate (famitinib malate) Famitinib malic acid, developed by Jiangsu Hengrui, is currently undergoing phase III clinical research for the treatment of malignant tumors, such as gastrointestinal stromal tumors, liver cancer, lung cancer, etc., while phase II clinical research for a variety of cancers is also in progress; in June 2008, Jiangsu Hengrui Pharmaceutical Co., Ltd submitted a clinical trial application (chemical 1.1) to the national CFDA, and approved the clinical trial in May 2009, with details See the table below: recombinanthuman endostatin (rhendostatin) developed by Wuzhong Pharmaceutical Co., Ltd., Jiangsu Province, is currently in the phase III clinical trial for the treatment of advanced non-small cell lung cancer and phase I clinical study for the treatment of advanced solid tumors See the table below for details: mb07133 Mb07133, in clinical phase III, is used to treat liver cancer; in 2007, the compound was qualified as an orphan drug in the United States for the treatment of primary liver cancer; the compound was initially developed by me tabasis (acquired by ligand in 2010) and authorized by ligand to CHIVA in 2011 In China, Xi'an Xintong applied for class 1.1 clinical study of the compound, and obtained the clinical approval document in March 2013 See the following table for details: disodium bretastatin A-4 3-o-phosphorate The research on the treatment of platinum resistant ovarian cancer, fallopian tube cancer, peritoneum cancer, lung cancer, liver cancer and cervical cancer with compretidine disodium phosphate, combined with monoclonal antibody and chemotherapy is currently in clinical phase III; the compound was discovered by Arizona State University, oxigen obtained the global right in 1997; azanta obtained the authorization of the drug from oxigene in Canada and Europe in 2011; February 2006 In March 2009, Chengdu Hengji Pharmaceutical Technology Co., Ltd and Tibet Xingxing Pharmaceutical Technology Co., Ltd submitted the clinical trial application (chemical 1.1) of conperyl diphosphate in China, and obtained the clinical trial approval in August 2010; 2 In March 2012, Shanghai Huali biomedical Co., Ltd submitted the clinical trial application (chemical medicine 1.1) of Constantine in China, and obtained the clinical trial approval document in December 2012 See the following table for details: fluorapacin (florapacin) Flutepropicin, developed by Essen bio (Hangzhou), is currently in clinical phase III in the study of rectal cancer; it is also used to treat the following indications: 1) application for the treatment of lung cancer, breast cancer, ovarian cancer and other malignant tumors; 2) application for the treatment of paclitaxel and other anti-tumor drugs after treatment failure or the generation of multidrug-resistant ovarian cancer and other malignant tumors; the compound was localized in China in April 2008 Class 1.1 clinical approval document of drug, phase I clinical trial was completed in 2011; meanwhile, Essen applied to CDE for phase II and phase III clinical study of flurapine in 2012, and obtained the clinical approval document in October 2015 See the following table for details: vorolanib Vorolanib, currently in clinical stage II / III, is combined with everolimus for the treatment of metastatic renal cancer; other clinical studies for the treatment of age-related macular degeneration, ovarian cancer, pancreatic cancer, renal cancer, colon cancer, macular edema, macular edema secondary to retinal vein occlusion (rvo-me), diabetic macular edema (DME), pathological myopia, choroidal neovascularization (mcnv) and other solid tumors are also included In progress; the compound was initially developed by tyrogenex (R & D code x-82), and its development right in China was authorized to kananji Pharmaceutical (R & D code cm-082) in 2009; vorolanib is an anti-tumor drug of tyrosine kinase inhibitor, whose R & D goal is to retain the efficacy of Pfizer sunitinib and significantly reduce toxicity; in May 2011, kananji Pharmaceutical Technology (Shanghai) Co., Ltd sent to China General Administration of food and Drug Administration (CFDA) submitted the clinical trial application (chemical class 1), and obtained the clinical trial approval document in April 2012 See the following table for details: do nafenib tosyllate (donafinil toluene sulfonate) donafinil toluene sulfonate, which is currently in clinical stage III, and is used for the treatment of advanced liver cancer and colorectal cancer At the same time, the second-line treatment of local advanced / metastatic radioiodine refractory differentiated thyroid cancer and the second-line treatment of advanced gastric cancer, advanced esophageal cancer and advanced nasopharyngeal cancer are also in the process of phase I clinical trials; in October 2015, Suzhou Zejing commissioned tag to carry out the phase III clinical study of donafinil toluenesulfonate tablets on liver cell cancer; in December 2011, Su Zhou Zejing biopharmaceutical Co., Ltd submitted the clinical trial application (chemical medicine class 1) to China CFDA, and obtained the clinical trial approval document on November 29, 2012 See the following table for details: Tyroserleutide (Tyroserleutide) Tyroserleutide, which is in clinical phase III, used for the treatment of liver cancer; April 2003, Shenzhen kangzhe Pharmaceutical Co., Ltd submitted the clinical trial application (chemical medicine class 1) to China CFDA, and obtained the clinical trial approval document on September 19, 2003 See the following table for details: glufosfamide (glufosamide) Glyphosamide, a DNA alkylation drug in the research of phase III clinical trials of eleson, is used to treat pancreatic cancer and advanced breast cancer; threshold pharmaceutical once carried out the research of phase III clinical trials of pancreatic cancer, but later the research was terminated; glyphosamide was originally researched by Baxter, and threshold company obtained the exclusive right worldwide in 2003; in 2009, eleson was threshold company Authorized to be responsible for global development and marketing; in China, GLP is applied by Qilu Pharmaceutical Co., Ltd and Jiangsu Haosen Pharmaceutical Co., Ltd for class 1.1 clinical research of Chinese chemical drugs, and the two companies obtained clinical approval documents in 2006 and 2008 respectively See the following table for details: sulfatinib Sofantini, developed by Hutchison Whampoa Pharmaceutical Co., Ltd., is in clinical phase III, which is used to treat pancreatic neuroendocrine tumors (including pancreatic neuroendocrine tumors and non pancreatic neuroendocrine tumors); at the same time, it is in clinical phase II, which is used to treat medullary thyroid cancer (including medullary thyroid cancer and differentiated medullary thyroid cancer) and cholangiocarcinoma; sofantini is a selective inhibitor Tyrosine kinase activity related to vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor 1 (FGFR1) and oral candidate drug of colony stimulating factor-1 receptor (CSF-1R) Fibroblast growth factor receptor 1 (FGFR1) is the receptor of protein that plays a role in tumor growth, The colony stimulating factor-1 receptor (CSF-1R) is involved in blocking the signal pathway of tumor-related macrophage activation, which can protect cancer cells from the killer attack of T cells At present, Hutchison Whampoa reserves all the rights of sofantini in the world Sofantini is the first swelling that Hutchison Whampoa independently completed the concept verification test in China and extended to the United States for clinical research For tumor candidate drugs, see the following table for details: paclitaxtide, paclitaxel, in clinical phase III, is used to treat breast cancer and non-small cell lung cancer; paclitaxel is composed of Bioscience was initially developed and sold to Sichuan Yuansheng biopharmaceutical industry, and then authorized to Hefei Anderson Pharmaceutical Co., Ltd to jointly develop the compound In October 2004, Sichuan Yuansheng biopharmaceutical industry applied for class 1.1 clinical application of Chinese chemical medicine, and in October 2005, it obtained clinical approval See the following table for details: zanubrutinib (bgb-3111) Bgb-3111 is a powerful and highly selective small molecule Btk inhibitor (Bruton tyrosine kinase inhibitor), which can block the related signal transmission, so as to inhibit the growth of malignant proliferation B cells and kill tumor cells; bgb-3111 is developed by Baiji Shenzhou, and single preparation and combination therapy drugs are proposed to treat various lymphoma (the most common type of blood tumor); bgb-3111 is currently used in Spain, Greece and Australia are carrying out phase III clinical research on the treatment of Waldenstr ö M's macroglobulinemia, and phase II clinical research on the treatment of recurrent or refractory mantle cell lymphoma (MCL), chronic lymphoblastic leukemia (CLL) and small cell lymphoma (SLL) in China;