Check the drugs approved for marketing in China since December

[China Pharmaceutical network industry trends] in order to meet the clinical needs and let our patients use "life-saving drugs" as soon as possible, since this year, in addition to speeding up the efficiency of domestic new drug approval and listing, China is also speeding up the speed of overseas new drugs approved and listed in China "For the drugs that have been listed overseas, which prevent and treat serious life-threatening diseases and rare diseases without effective treatment means, and which are confirmed by research to be free of ethnic differences, the applicant does not need to apply for clinical trials, and can directly apply for listing with the data of overseas trials, and the time of drug listing will be accelerated by 1-2 years," said the relevant person in charge The State Food and drug administration has also issued relevant policies and measures to further encourage the domestic listing process of overseas new drugs For example, encourage the domestic and foreign simultaneous research and development, application and registration of innovative drugs For the clinical trial data obtained through the international multi center clinical trials that meet the relevant requirements of drug registration, directly approve the listing, so that our patients can use innovative drugs with accurate efficacy and controllable safety risks as soon as possible, and better meet the drug demand of the public So, since December, what drugs have been approved for marketing in China? The author makes a brief inventory Losarta Capsule on December 18, the State Food and Drug Administration issued a notice that losarta capsule (trade name: aridrol), a new drug for the treatment of renal anemia, was approved for marketing The drug is not currently available in any other country According to the announcement, losartan capsule is the first small molecule hypoxia inducible factor prolyl hydroxylase inhibitor (HIF phi) drug developed in the world for the treatment of renal anemia Its listing will provide a new treatment for anemia patients caused by chronic kidney disease Patuzumab injection on December 17, the State Food and Drug Administration issued a notice, patuzumab injection (English Name: pertuzumab injection) for the treatment of breast cancer was approved for marketing According to the announcement, patozumab injection is a new type of anti HER2 drug developed by Roche company Compared with the current standard treatment of trastuzumab combined chemotherapy, the adjuvant treatment of HER2 positive early breast cancer patients with high risk of recurrence significantly improves the patient's non-invasive disease survival period, and the adverse reactions are controllable On December 17, the State Food and Drug Administration issued an announcement that the domestic PD-1 antibody drug trepril mAb injection (trade name: tuoyi) was approved for listing This is an innovative biological product drug independently researched and developed by Chinese enterprises with full independent intellectual property rights, which is used to treat local progress or metastatic melanoma after the failure of previous standard treatment It is developed by Suzhou Zhonghe Biological Medicine Co., Ltd Compared with the traditional chemotherapy and targeted therapy, trepril mAb is a new anti-tumor therapy concept, which can kill tumor by overcoming the immunosuppression in patients and reactivating their own immune cells Selexipag tablets, which is used for the treatment of rare diseases, was approved for marketing on December 12 by the State Food and drug administration According to the announcement, celepax tablet is an effective, highly selective and long-acting non prostaglandin prostaglandin receptor (IP receptor) agonist, which can improve the endothelium-dependent relaxation of injured pulmonary artery, and may inhibit the proliferation of human pulmonary smooth muscle cells and the thickening of pulmonary vascular wall Compared with the prostacyclin drugs which have been marketed for the treatment of pulmonary hypertension, this product is an oral preparation, which can improve the compliance of patients In addition, the product is convenient to use, avoiding the reaction at the injection site of intravenous administration, and avoiding the throat irritation reaction and cough of inhalation dosage form.