CDE drug review weekly report (March 1-March 15, 2015)

Among the 70 drugs that entered the approval process in the first half of March, there were 51 chemicals, 10 traditional Chinese medicines and 9 biological products for treatment There are a lot of class 1 new drugs in the chemical industry entering the approval stage Let's first look at which drugs are available: weikagre tablets of Jiangsu Weikeli Pharmaceutical Technology Co., Ltd., which was undertaken by CDE in May 2014, are not only major special varieties, but also special approval varieties At present, they have entered the approval stage I wonder if they will directly approve the clinical application Wicagrel is a new antithrombotic drug developed by wilkell in cooperation with China Pharmaceutical University Aiming at the clinical defects of clopidogrel, the world's second-largest best-selling drug, according to the mechanism of action of clopidogrel, it is designed and developed in close combination with international clinical research and application Compared with clopidogrel, it can benefit some patients who are unable to metabolize clopidogrel, and its efficacy and onset time are significantly better than clopidogrel Celarevir potassium tablet of ginkgo tree Pharmaceutical (Suzhou) Co., Ltd was undertaken by CDE in January 2014 It is a special approved variety It was issued and supplemented once in January 2015 After a short period of two months, it has entered the approval stage and is expected to be approved successfully According to its name, this product is supposed to be an anti hepatitis C drug It is a new drug under the pressure of many effective oral anti hepatitis drugs in foreign countries Although it has just started, it is also relatively fast in China Aibenatide injection of Hebei Changshan Biochemical Pharmaceutical Co., Ltd was also undertaken by CDE in January 2014 It is also a special approval variety It experienced a supplement in December 2014 and is also in the approval stage Ibn is an intestinal hypoglycemic analog It is a unique patent drug affinity (DAC) transferred to the joint venture company by Changshan biochemical and CO njuchem LLC through its contribution (E) New drugs produced by technology are used for the treatment of type 2 diabetes Before the transfer of the drug to the joint venture company, Co njuchem LLC has completed phase I and phase II clinical trials in the United States and Canada According to the phase I and phase II research data, the drug has the advantages of long half-life, good clinical tolerance, once a week administration, and positive effect The injection of huaporphyrin sodium of Qinglong High Tech Co., Ltd was undertaken by CDE in October 2013, supplemented in January 2015, and has entered the final stage of approval This product is not only a major special variety, but also a special approved variety Hua porphyrin sodium is a new photosensitizer created by the research group of Fang Qicheng Professor, Institute of medicine, Chinese Academy of Medical Sciences It is a single chemical component separated from Photofrin The chemical composition of the product is single, the effective component is clear, the quality standard is controllable, the property is stable, the singlet oxygen output is high, and it is expected to be a more ideal photosensitizer than Photofrin for the treatment of tumor The M6G injection of Jiangsu Hengrui Pharmaceutical Co., Ltd was undertaken by CDE in July 2013, and experienced a supplement in November 2014, which is currently in the approval stage M6G injection is an analgesic drug, the detailed mechanism is not known Tazarotene betamethasone cream of Chongqing Huabang Pharmaceutical Co., Ltd was undertaken by CDE in April 2012, and was issued in March 2013 This product is a major national special product, and has completed the three in one review Tazarotene betamethasone cream is a new compound which is not listed in China, and is mainly used in the treatment of psoriasis Let's look at other new drugs and generic drugs: the raw materials, capsules and tablets of olmesartan ester, a class 3.1 new drug of Fujian Tianquan Pharmaceutical Co., Ltd., started to undertake its production application in April 2010 After two supplements in May 2012 and October 2012, CDE has completed the three in one review so far, and the batch production will be ready soon At present, there are only 4 domestic enterprises of olmesartan ester tablets, including 1 import and 3 domestic enterprises However, capsule is not listed yet, and Tianquan capsule can be regarded as the exclusive dosage form The 3.2 new compound roxithromycin ambroxol tablets of Shandong Luoxin Pharmaceutical Co., Ltd entered the evaluation center in March 2011 to wait for evaluation In March 2012, they experienced a supplement and issuance So far, the three in one evaluation has been completed, which is also to be approved for listing Roxithromycin and ambroxol tablets are used to treat bacterial acute bronchitis, chronic bronchitis and elderly chronic bronchitis caused by sensitive bacteria At present, only one roxithromycin ambroxol dispersible tablet produced by Jiangsu Yabang Epson Pharmaceutical Co., Ltd is on the market in China Compared with the dispersible tablet, whether the ordinary tablet has better efficacy and compliance still needs to be discussed in terms of sales volume Sichuan Tuopai Pharmaceutical Co., Ltd.'s balanced salt washing solution entered the evaluation center in December 2012, and has not experienced the issuance and supplement So far, it has completed the three in one evaluation and is about to be produced At present, this product is only produced and sold in China It is mainly used for all kinds of surgical flushing, irrigation, cleaning, etc which are allowed to use electrolyte solution It can also be used as the flushing fluid for endoscopic surgery and various joint cavity Shetaconazole nitrate suppository of Hainan haishentongzhou Pharmaceutical Co., Ltd entered the evaluation center in August 2010 and experienced a supplement in January 2012 At present, the three in one evaluation has been completed At present, shetaconazole nitrate is only available in cream market in China, but suppository has not yet been listed, which is mainly used to treat candidal vaginitis From the above point of view, it is relatively fast to apply for class 1 clinical approval After all, it is a major special project and special review However, it takes a long time to apply for production of class 3.1, which is often 4-5 years In addition to applying for clinical application and doing clinical work, it will take a 10-year mala Next, we will introduce the imported and re registered drugs approved this half month: e5501 tablet of Weicai pharmaceutical, chemical name avatrombopag, is a daily oral thrombopoietin agonist for the treatment of thrombocytopenia related to liver diseases At present, several phase III clinical trials have been completed in the United States Novartis sodium epoprost for injection is a kind of drug for the treatment of pulmonary hypertension At present, it is not listed in China, and only Novartis has applied for clinical application In the first half of March, only one drug was approved, which is the imported biological product human serum albumin of auctfumar AB (Sweden) After the completion of the preparation of the certificate, in the first half of March, there were 60 chemical drugs, 3 biological products for treatment and 5 biological products for prevention The chemical information is as follows: 1.6 new indications of lobaplatin for injection of Hainan Chang'an International Pharmaceutical Co., Ltd entered the evaluation center in December 2013, experienced a supplement in October 2014, and now the preparation of the certificate has been completed 3.1 all kinds of preparations are for clinical application It's a long way from production Come on, pharmaceutical companies In the first half of this month, most of the generic drugs were antibiotics Under the anti drug restriction order, the use of antibiotics by Chinese people is still the largest, and the sales of antibiotics are increasing gradually every year, although the growth rate is relatively small The so-called, there is demand, there is production! Elibixibat, th-302 and TMC207 are in the 26 issue of the weekly report Enmd-2076, developed by entremed, is an oral Aurora A / angiogenic kinase inhibitor with unique kinase selective properties and multiple mechanisms of action In addition to Aurora A kinase, enmd-2076 also has a distinct inhibitory property on angiogenesis Aurora kinase is a key regulator of mitosis and is often overexpressed in human cancer Enmd-2076 also targets vefgr, Flt-3 and FGFR3 kinases, which have been shown to play an important role in the pathology of many cancers In phase I clinical trials, enmd-2076 has shown the potential to treat solid tumors, leukemia and multiple myeloma At present, the clinical application of enmd-2076 in stage II of ovarian cancer is about to be completed