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    Home > Medical News > Latest Medical News > TNF α monoclonal antibody and rhTNF α: FC domestic declaration and inventory

    TNF α monoclonal antibody and rhTNF α: FC domestic declaration and inventory

    • Last Update: 2016-12-19
    • Source: Internet
    • Author: User
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    1、 List of domestic applications: Note: cimzia from UCB and simponi from Johnson & Johnson are also under application In addition, koningjeri kn002 is a biological analogue of adalimumab 2、 List of related listed varieties: 1 Adalimumab: (1) adalimumab is a humanized monoclonal antibody against human tumor necrosis factor (TNF α), which was jointly developed by Cambridge anti technology and Abbott, and was first listed in the United States in 2003 Xiumeile achieved $7.7 billion in the first half of 2016 and more than $14 billion in 2015 Some analysts predict that xiumeile's sales will reach US $15 billion in 2020 (2) In 2015, the data of sample hospitals in China was less than 200 million yuan At present, only RA (rheumatoid arthritis) and as (ankylosing spondylitis) are approved in China 2 Infliximab: (1) Lek reached US $4.2 billion in the first half of 2016 and US $8.4 billion in 2015 Jointly promoted by Johnson & Johnson and MSD (2) In 2015, the domestic sample hospitals were about 300 million yuan The indications approved in China are rheumatoid arthritis, ankylosing spondylitis, Crohn's disease and psoriasis 3 Inarcept: (1) USD 4.4 billion in the first half of 2016 and USD 8.7 billion in 2015 Jointly promoted by Amgen and Pfizer (2) In 2015, the domestic sample hospitals were less than RMB 100 million 4 Domestic products: Note: the sales volume of yisaipu comes from the annual report However, for qiangke, a source said that SAIJIN disclosed that the sales volume in 2015 was about 200 million 3、 Progress of Companies: 1 Qilu pharmaceutical: rhTNFR: FC treatment of moderate and severe active ankylosing spondylitis (as) effectiveness and safety of randomized, double-blind, placebo-controlled, multicenter phase III clinical trial (Registration Number: ctr20140351) is still shown in the recruitment, but the use of placebo-controlled The primary end point was the proportion of patients who achieved the improvement of asas20 at the 6th week RhTNFR for injection: the randomized, double-blind, placebo-controlled, multicenter phase III clinical trials of the efficacy and safety of FC in the treatment of moderate and severe active rheumatoid arthritis are also being recruited 2 Lizumab: phase I clinical trial (for RA) of at132 (recombinant human anti-tumor necrosis factor α monoclonal antibody for injection) single center, randomized, double-blind, placebo-controlled, single dose, dose-increasing human tolerance and preliminary pharmacokinetics was completed in November 2014 In addition, the phase I clinical trial of increasing dose and multiple administration of at132 in RA patients was completed in March 2016 3 Suzhou Jinmeng / Chengdu Jinkai (xinlitai): recruitment of single and multi dose phase I clinical trial of recombinant human TNF receptor antibody fusion protein for injection in the treatment of active ankylosing spondylitis has been completed 4 Haizheng Pharmaceutical Co., Ltd.: the first randomized, double-blind, positive drug controlled phase III clinical trial (Registration No.: ctr20160398) in China to compare the efficacy and safety of hs016 (recombinant anti-tumor necrosis factor - α all human monoclonal antibody injection) and sumerial in the treatment of active ankylosing spondylitis was enrolled on September 27, 2016 603 people were enrolled in the domestic target group Main end points and evaluation indexes: 5 Xinda biology: randomized, double-blind, parallel controlled phase III clinical study comparing the efficacy and safety of ibi303 and adalimumab in patients with active ankylosing spondylitis was also recruited in September this year The domestic target is 400 people 6 Baiaotai: (1) a multicenter, randomized, double-blind, adalimumab parallel controlled phase III clinical trial is being recruited to evaluate the efficacy and safety of bat1406 injection in the treatment of ankylosing spondylitis It is rare to write the end date of phase III (2) The comparative study of pharmacokinetics and safety of bat1406 injection with adalimumab European products and American products in Chinese healthy subjects (for RA) is also a rare registration, which may have something to do with their overseas market development Before that, we had cooperation with Kuntai 7 Fuhong Hanlin: a randomized, double-blind, parallel control study was conducted among Chinese healthy male subjects to compare the pharmacokinetic characteristics, safety, tolerance and immunogenicity of hlx03 and sumerial for the first time in December 2016 8 Sansheng pharmaceutical: single dose of human TNF α monoclonal antibody injection (CHO cells), a randomized, double-blind placebo-controlled trial with increasing dose, was registered in the system in July 2015 9 Jiangsu Zhonghe medicine: the first subject in the pharmacokinetics comparison test of single subcutaneous injection of recombinant human anti TNF - α monoclonal antibody injection in healthy volunteers was enrolled in October 2016 The external funds for the test of Zhonghe recombinant human anti TNF - α monoclonal antibody injection are funded by the major science and technology special project of "major new drug creation" 10 Jiahe biology: the recruitment of clinical study to evaluate the PK comparison of single administration of recombinant anti TNF alpha human mouse chimeric monoclonal antibody for injection in healthy volunteers has been completed 11 Zhangjiang Bio: (1) the first subject of T0001 injection was enrolled in the group in 8, 2015 (2) In addition, a phase III clinical study has been completed by Shanghai Zhangjiang biological research and Development Co., Ltd., which has applied for the production approval document from BMB in China Http://www.biomabs.com/info.asp? Id = 115 12 Corning Jerry: kn002 is the biological analogue product of adalimumab developed by Corning Jerry The data of quality study and structure characterization showed that kn002 was comparable with the original drug in physical and chemical indexes, while the pharmacodynamic evaluation showed that its biological activity was similar to that of adalimumab, and it was highly comparable in the pre clinical pharmacokinetics and safety evaluation Kn002 has applied for the clinical application of class 2 new drugs in July 2013 At present, RA indications are in phase I http://www.alphamab.com/content/details_19_152.html …… Welcome to add For more information, please refer to clinical trial registration center, yaozhi.com, official platforms of various companies, etc Note: This article is original by the author of yaozhi.com, welcome to reprint, please indicate the source and author when reprint, thank you!
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