CDE drug review weekly report (2016.08.01-2016.08.07)

Highlights of this week 1 There are still 15 drugs in the review status this week, including 3 3.1 categories (by variety), namely, the sakubitravalin trisodium and pentahydrate tablets (acceptance No.: cxhl1501876) of Harbin Anbo biology; the vorozan and tablets of fumarate (acceptance No.: cxhl1600053, cxhl1600054, cxhl1600055) of Nanjing Haina; and the joint declaration of Sichuan Baili and Guorui Venacaran hydrochloride and injection (acceptance No cxhl1502399, cxhl1502400, cxhl1502401) There is no category 1.1 and import registration this week 2 So far, there are 13 domestic enterprises applying for Novartis new anti heart failure drug valsartan sacubitril (lcz-696), among which the first one is Wanbang, Jiangsu Province, which has been certified in June 2016 From the review process, it should be not approved At present, there are 12 companies under review, the fastest of which is Jiangsu Haosen, followed by Jiangsu Hengrui and Shenzhen xinlitai At present, hausen's review has been completed, but it has not been approved yet I don't know if the clinical approval is successful Hengrui and xinlitai are under review, and they should be finished soon Beijing kanglisheng, who is close behind, is still in line 3 There are 64 drugs under examination and approval after the review this week, including one class 1.2 chemical, Ginkgolide B sodium chloride injection of Guangdong aiside This product was applied for clinical application in 2010, and the drug type is chemical medicine However, according to the subsequent review process, it should be reviewed in the traditional Chinese medicine / natural medicine department It is a special approved variety, and it will be supplemented once in 2015 At present, I do not know whether it is approved for clinical application Among Ginkgolides, Ginkgolide B has the strongest physiological activity and is the strongest platelet activating factor antagonist so far, which is used to treat the syndrome of phlegm and blood stasis blocking collaterals in ischemic stroke The General Hospital of the people's Liberation Army has submitted an application for the production of Ginkgolide B injection with traditional Chinese medicine category 1.1, but the announcement was withdrawn 4 Shanghai Pharmaceutical recombinant anti-CD20 humanized monoclonal antibody injection has been reviewed This product is intended to be used in lymphoma and rheumatoid arthritis It is based on the structure of human mouse chimeric monoclonal antibody rituximab Compared with mouse antibody and human mouse chimeric antibody, this humanized anti-CD20 antibody not only retains or improves the high affinity of variable region, but also reduces the immunogenicity of chimeric antibody, so as to reduce the side effects of drugs and improve clinical practice Therapeutic effect At present, most domestic enterprises apply for human mouse chimeric CD20 monoclonal antibody, and Shanghai Pharmaceutical is the first one to apply for human modified CD20 monoclonal antibody, which was supplemented once in April 2016 At present, the review is completed, and it is speculated that it should be approved clinical, waiting for announcement 5 The clinical application of medi4736 and tremelimumab, two anticancer drugs of AstraZeneca, was reviewed for the first time in China Medi4736 is an anti-PD-L1 drug that works by preventing tumors from escaping immune system defenses Tremelimumab is an all humanized monoclonal antibody against cytotoxic T lymphocyte antigen 4 (CTLA-4), which can block the signal pathway to help tumor escape immune examination Tremelimumab stimulates the immune system to attack tumor cells by binding CTLA-4 protein expressed on the surface of activated T lymphocytes This two pronged approach aims to expose cancer cells as fully as possible to the lethality of the body's autoimmune system Although in clinical trials, the treatment of some tumors did not reach the end point of effectiveness, AstraZeneca has been exploring the best use mode and indications of these two drugs In the clinical trials of non-small cell lung cancer, it has reached stage 3, and is expected to be available in the near future 6 Jiangsu Hengrui pyrrolidine maleate tablets were registered in phase 3 clinical trials At present, the product has registered 6 clinical trials on CDE drug clinical trial registration and information publicity platform, including 4 phase I, 1 phase II, and 1 phase III this week These six tests are all in progress, I, II, III together The third phase of this week's registration is the study of pyrrolidine maleate and capecitabine in the treatment of advanced breast cancer The indication is HER2 positive advanced breast cancer Objective: To evaluate the efficacy of piratinib plus capecitabine versus placebo plus capecitabine in the treatment of progression free survival (PFS) of HER2 positive metastatic breast cancer Secondary study objective: To compare the orr, DOR, DCR, CBR and OS of the pyrrolidine plus capecitabine group with that of the placebo plus capecitabine group To evaluate the safety of pyrrolidine combined with capecitabine in the treatment of HER2 positive metastatic breast cancer The group leader unit is the third seven hospital of the Chinese people 's Liberation Army On June 24, 2016, through ethics, 15 centers were registered, including the group leader unit At present, it is in progress and has not yet been recruited, and 350 people are planned to join the group.