List of domestic application of trastuzumab

1 Enterprises obtaining clinical approval: Note: the first approval time is listed Shenzhou cells are class 1 biological products for treatment, which are all human monoclonal antibodies, not biosimilar 2 Other enterprises applying for clinical application: Source: Pharmaceutical intelligence data Lizhu pharmaceutical is class 1 biological products for treatment 3 CITIC Guojian is the first company in China to apply for clinical application and approve clinical application (July 2004); it is the first company to apply for production, but unfortunately, in the tense situation, siputin withdrew obediently (August 2016) When will all matters be completed and then report for production again 4 In 2015, the sales volume of trastuzumab injection (Herceptin ®) in China was about 890 million yuan 5 Clinical trial progress: http://www.chinadrugtrials.org.cn (1) Fuhong Hanlin: phase III trial comparing the safety and efficacy of hlx02 and Herceptin in the treatment of breast cancer (Registration No.: ctr20160526) was published in September 2016 The international multicenter parallel randomized double-blind trial was carried out The control group was Herceptin Target group: international multicenter trial: 606 in total, 406 in China In addition, Fuhong Hanlin also obtained the clinical approval of gastric cancer indications (2) Jiahe biology: a randomized, double-blind, multicenter phase III clinical study (Registration No.: ctr20160389) on the treatment of HER-2 positive advanced breast cancer with recombinant anti-Her-2 humanized monoclonal antibody for injection or placebo combined with capecitabine, also began recruitment in September 2016 Trial group: there was no comparison with Herceptin - the trial standard was greatly reduced Maybe it's not a biosimilar relationship, which can't be consistent with Herceptin and reduce the risk (whether the sequence is consistent may need to be compared with database or patent query) (3) Qilu pharmaceutical: the multi center pharmacokinetic and safety phase IB clinical study (Registration No.: ctr20140740) of recombinant anti HER2 humanized monoclonal antibody for injection in patients with metastatic breast cancer is still in progress It was first publicized in November 2014 Objective: To observe the pharmacokinetics and safety of anti HER2 mAb in patients with HER2 overexpressed metastatic breast cancer every week and every three weeks, and to observe the curative effect (4) Anke biology: the clinical study (Registration No.: ctr20160642) to evaluate the pharmacokinetics comparison test of single dose of recombinant human HER2 monoclonal antibody for injection in Chinese healthy adult volunteers began recruitment in August 2016 The control drug was Herceptin The first patient was enrolled on August 22, 2016 Other enterprises have no information yet, waiting for update Welcome to add missing companies and information Note: This article is the original manuscript of the author of yaozhi.com, welcome to reprint, please indicate the source and author when reprint, thank you!