Raw materials and tablets approved

Approval for clinical trial of drugs: approval for clinical trial of drugs obtained from raw materials and tablets of rivaroxaban, a subsidiary Recently, Zhejiang Jinhua kangenbe biopharmaceutical Co., Ltd (hereinafter referred to as "Jinhua kangenbe"), a holding subsidiary of Zhejiang kangenbe Pharmaceutical Co., Ltd (hereinafter referred to as "the company"), received the approval for clinical trials of rivaroxaban raw materials and rivaroxaban tablets approved and issued by the State Food and Drug Administration The relevant information is hereby announced as follows: 1 Main contents of clinical trial approval (1) rivaroxaban 1 Drug name: rivaroxaban 2 Approval No.: 2016l06373 3 3 Dosage form: API 4 Specification: --- 5 Application items: domestic drug registration 6 Registration classification: protochemicals 3.1 class 7 Applicant: Zhejiang Jinhua Kangenbei Biological Pharmaceutical Co., Ltd 8 Approval conclusion: after examination, the product meets the relevant requirements of drug registration, and it is agreed to carry out human bioequivalence (be) test for the product preparation （2） Rivaroxaban tablet 1 Drug name: rivaroxaban tablet 2 Approval No.: 2016l06307 3 Dosage form: tablet 4 Specification: 10mg 5 Application items: domestic drug registration 6 Registration classification: original chemical drug category 6 7 Applicant: Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd 8 Approval conclusion: after examination, the product meets the requirements of drug registration, and it is agreed to conduct human bioequivalence (be) test 2、 The main indication of rivaroxaban tablet is to prevent venous thrombosis (VTE) in adult patients undergoing selective hip or knee replacement The recommended dose is 10 mg of rivaroxaban once a day Rivaroxaban is the first direct XA factor inhibitor in the world, which can directly inhibit the free or binding XA factor with high selectivity and produce anticoagulant effect XA factor is the binding point of endogenous coagulation pathway and exogenous coagulation pathway, and plays a key role in the coagulation process Many studies have shown that single inhibition of XA factor can be more effective in anticoagulation, with predictable efficacy, wide therapeutic window and no effect on normal hemostasis It has the characteristics of high bioavailability, wide treatment spectrum, stable dose effect relationship, convenient oral administration and low risk of bleeding Rivaroxaban can be absorbed orally for a long time It can only be taken once a day It has a wide therapeutic window and does not need routine coagulation monitoring The original research unit of the product is Bayer company of Germany, which was listed in the European Union and Canada in 2008 In July 2011, it was approved by FDA to be listed in the United States, and the product is named xarelto In June 2009, it was approved to be imported and listed in China under the name of "bairituo" Rivaroxaban raw materials and tablets are products jointly developed by Jinhua Kangenbei and Nanjing Huawei Pharmaceutical Technology Development Co., Ltd the registration application for the product was submitted in May 2015, and the approval for clinical trials of drugs was recently issued by the State Food and drug administration Up to now, the company has invested about 3.8 million yuan in research and development of the product Jinhua Kangenbei will carry out the human bioequivalence (be) test in strict accordance with the requirements of the above clinical trial approval documents, and submit the clinical trial report and relevant requirements documents to the State Food and drug administration after the completion of the human bioequivalence (be) test, and apply for the production registration approval documents and new drug certificate 3、 Other relevant information up to now, only Bayer of Germany has obtained the import approval document of the product in China At present, in addition to the imported rivaroxaban tablets, rivaroxaban APIs and other dosage forms have not been listed in the domestic market At present, a total of 30 domestic enterprises (including Jinhua Kangenbei) have obtained the approval of clinical trial of rivaroxaban tablets, but no enterprise has yet applied for production Thirty enterprises, including zhongchenxin Pharmaceutical Co., Ltd., Jilin ASEAN Pharmaceutical Co., Ltd., Jiangsu Jiayi Pharmaceutical Co., Ltd., Nanjing kefeiping Shenghui Pharmaceutical Co., Ltd and Zhengda Tianqing Pharmaceutical Group, have applied for class 3.4 new drug clinical application and class 6 generic application, all of which have been approved for clinical application; 25 enterprises have applied for class 6 generic application and approved for clinical application According to IMS data, the global sales of rivaroxaban tablets from April 1, 2014 to March 31, 2015 were US $4.316 billion, up 66.23% year on year According to the clinical purchase data of 360 sample hospitals in 22 cities / regions of China Pharmaceutical Association, the clinical purchase amount of rivaroxaban tablet sample hospital in 2015 was 164793600 yuan, an increase of 29.50% year on year In the first quarter of 2016, the clinical purchase amount of rivaroxaban sample hospital was RMB 50.06 million, which was 30.34% of the annual clinical purchase amount of rivaroxaban in 2015.