CDE drug review weekly report (2016.06.12-2016.06.19)

Abstract: this week, two tinines made the headlines, one is that the yifeitini tablet of Yangtze River entered CDE, and the other is that the review of four ring celotinib tablet was completed In addition, AstraZeneca anti asthma monoclonal antibody tralokinumab injection was applied for clinical application for the first time in China Phase I clinical trial of Mitoxantrone Hydrochloride liposome injection and sklb1028 capsule was carried out in zhongqikai Review and approval points: 1 Yangzijiang Pharmaceutical Co., Ltd continues to apply for a class 1.1 chemical drug this month: ifetinib tosilate and its tablets; 2 Kananji CM082 tablet is again applied for clinical application, so it is necessary to do a good job in the future; 3 AstraZeneca single antibody tralokinumab injection (cat-354) for the treatment of asthma and other immune system diseases The first clinical application was made in China; 4 The review of sirotinib maleate, a new drug of 1.1 class from xuanzhu, Shandong Province, was completed this week; 5 The review of androdifene citrate, a new drug of 1.1 class from madixian, Suzhou, was completed this week; 1 The first phase I clinical trial of Mitoxantrone Hydrochloride liposome injection was registered in China According to Xianda data v3.2, the product was approved as a class 5 drug with modified dosage form and not changed administration route as early as 2010 The purpose of this registration is to observe the safety and tolerance of Mitoxantrone Hydrochloride liposome injection in patients with malignant lymphoma, and to explore the preliminary efficacy It was carried out in the fourth hospital of Hebei Medical University, and 34 subjects were planned to be enrolled 2 Sklb1028 capsule, a Chinese traditional medicine Zhongqi 1.1, was registered in phase I clinical trial for the first time in China The indication was FLT3 mutant acute myeloid leukemia This experiment passed the ethics committee of West China Hospital of Sichuan University At present, there is only one participating institution, and 18 cases are planned to join the group Sklb1028 capsule has two specifications: 10mg and 30mg According to Xianda data v3.2, the product was approved for clinical use in February 2016 Soon, the organization was contacted and started! 3 Sct400 injection: This product was developed by Shenzhou cells and registered in CDE as phase I clinical trial as early as September 2014 In June 2012, the first patient was enrolled and the trial was terminated in July 2013 The indication was CD20 positive B-cell non Hodgkin's lymphoma According to Xianda data v3.2, Xiaobian speculated that this biological product is a recombinant human mouse chimeric anti-CD20 monoclonal antibody injection, which was approved in August 2011 Since then, the phase II clinical trial was registered in 2015, and 80 people are planned to be enrolled At present, they have not been recruited, and the indication is still CD20 positive non-Hodgkin's lymphoma The purpose of this trial is to compare the pharmacokinetics of sct400 and rituximab injection in a single dose of CD20 positive B-cell NHL patients, but not recruited This week, phase III clinical trial was registered The indication was CD20 positive diffuse large B-cell lymphoma (DLBCL) Objective to evaluate the clinical effectiveness of sct400 combined with chop (s-chop) as a first-line treatment in patients with DLBCL Introduction to key drugs: This product is declared by Yangzi River and Hailong, including raw materials and 1 specification tablet, which is currently in the review stage The acceptance numbers are cxhl1502137 and cxhl1502138 respectively, which should have been accepted in 2015, and this year, they will enter the evaluation center and wait in line for review In addition, a class 1.1 new drug, yzj-1139 and its tablets, just entered the evaluation center last month in Yangzijiang Pharmaceutical Co., Ltd., and this drug was accepted in 2016, and soon entered the evaluation center At present, no more detailed information has been found on ifletinib tosilate tablets and yzj-1139 tablets CM082 tablets: This is the second time that the small edition has written this 1.1 drug The first time is the review weekly report of phase 69 At that time, this product has been applied on the basis of two clinical approvals This time, it is still applied for clinical application It seems that there are many indications The first clinical approval of this product should be in 2013, and the first registration should be made on the CDE clinical trial information registration and publicity platform in May 2014, with the purpose of "phase I study on the safety, tolerance and pharmacokinetics of CM082 tablets in the treatment of patients with advanced cancer" Since then, 3 acceptance numbers have been approved in January 2015, and registered on the platform in June 2015, September and December respectively They are all phase I clinical trials, and the indications include: wet age-related macular degeneration, advanced renal cancer (combined with everolimus) After obtaining two clinical approvals, the company continued to apply for clinical application in December 2015 and January 2016, until this week, the company applied for clinical application again, it seems that the company really wants to make this drug For other information about this drug, please refer to review weekly report no 69 Tralokinumab injection: This product is a monoclonal antibody against human IL-13 neutralizing immunoglobulin G4, which was first obtained in the antibody laboratory in Cambridge It first entered the clinical practice in 2004 In July 2011, MedImmune company (acquired by AstraZeneca) carried out the phase IIB clinical trial of this product in the treatment of adult asthma In 2014, phase III clinical trials for asthma treatment began, and are still in the recruitment stage Sirotinib maleate tablets: sirotinib is a new generation of irreversible pan her inhibitor It is the second new anti-cancer drug independently developed by xuanzhu pharmaceutical, a subsidiary of the Fourth Ring Road, which is used to treat esophageal cancer, gastric cancer, lung cancer and other advanced cancers In recent years, xuanzhu medicine has applied for 1.1 new drugs, including fudanafil tablets, gaggliptin tablets, pirotinib hydrochloride tablets, and telodipine hydrochloride tablets, among which the last three have been approved for clinical use Sirotinib tablet entered CDE in October 2015, which is a special approved variety If there is no accident, it is also approved for clinical use Xiondenfei citrate tablets: This product was declared by Suzhou medixian Pharmaceutical Technology Co., Ltd and no specific information was found However, according to its drug name, it can be inferred that it is a PDE5 inhibitor, which is consistent with sildenafil for the treatment of ED This product entered the review center in September 2015 and has been reviewed.