[drug gajun] it was checked in the middle of the year, and these drugs were approved in China in 2018 (attached with the list); this week, the heavyweight new drugs of Nephrology, rosaseta, and the third generation new drugs of lung cancer, ivetinib

According to the data of drug intelligence, CDE has undertaken three new drug NDA applications in recent two weeks As shown in the following table: rosadostat (fg-4592) is an inhibitor of hypoxia inducible factor prolinyl hydroxylase (hif-ph), which can inhibit the ubiquitin degradation of HIF, help the body produce more red blood cells, and develop for the treatment of anemia in CKD patients In 2017, as soon as the news of phase 3 clinical completion came out, it was widely concerned On June 29, the drug's NDA application was undertaken by CDE, and entered the sequence on July 3 According to the registration timeline, it is expected that the drug will probably be approved in the first quarter of 19 years In addition, the drug was applied for marketing in November 2017, and was included in the priority review in December because of its obvious treatment advantages compared with the existing treatment methods It is expected to be approved in the third quarter of 2018, and the drug is considered by the industry to be the first class 1.1 new drug in global R & D in China On June 25, Zhejiang huisong Pharmaceutical Co., Ltd.'s NDA application for a new drug for treating AIDS, named "Cha Du Cao Heji", was accepted In September 2010, the drug was approved by the State Food and drug administration It is the only new Chinese medicine for treating AIDS that entered the clinical trial in China Zhejiang huisong Pharmaceutical Co., Ltd is a joint venture between China, Japan and the United States, which was established in October 1998 Its main business scope includes: production and sales of natural medicinal plant extracts, drugs and food; introduction, cultivation, processing and sales of natural plants and traditional Chinese medicine At present, the products are mainly exported and sold well in dozens of countries and regions such as Europe, America, Japan and Australia The company is a provincial high-tech enterprise and one of the top ten enterprises in the export of Chinese herbal pieces and extracts China's independent research and development of the third generation of lung cancer drug avetinib maleate capsule NDA application was undertaken On June 25, Zhejiang Eisen Pharmaceutical Co., Ltd applied for the NDA application of ivetinib maleate capsule, which is the original national class 1.1 new drug independently developed by Eisen Pharmaceutical Research Co., Ltd and the first third generation EGFR inhibitor to enter clinical research in China It was supported by the national 12th Five Year Plan major new drug creation project, mainly used to treat the resistance of the first generation EGFR target drug after use Non-small cell lung cancer Mid year market point According to drug intelligence data, from January 1 to June 30, 2018, CDE approved 19 new drugs (acceptance number, the same below), including the highly concerned thiopefelistine injection of Hengrui, enrotinib hydrochloride capsule of Zhengda Tianqing, danorevir sodium tablet of Geli, ibovectal for injection of cutting-edge biology, desetabine for injection of Wanle, and 19 imported drugs Drugs, 118 generic drugs approved The details are shown in the following table: new drugs approved in the first half of 2018, imported drugs approved in the first half of 2018, generic drugs approved in the first half of 2018, and new therapies for schizophrenia approved by FDA, which can be used on the first day On July 3, Alkermes announced that the FDA of the United States approved aristada initio Gamma (aripiprazole laurox) as a long-term injection of the atypical antipsychotic drug aristada ® (aripiprazole laurox) to start the program for the treatment of adult schizophrenia This is aristada initio Gamma First used in combination with 30 mg single dose oral aripiprazole, it provides an alternative for doctors to start any dose of aristada ® for patients on the first day The drug is expected to be available in mid July A new generation of antibiotics for the treatment of complex urinary tract infection, zemdri, has been approved for marketing Recently, achaogen announced that the US FDA has approved the marketing of its zemdri (plazomicin) for the patients with complex urinary tract infection (CTU) caused by some Enterobacteriaceae, including those with pyelonephritis Zemdri is an intravenous drug given once a day It is worth mentioning that this approval makes zemdri the only daily aminoglycoside therapy for CTU Recently, Roche, a Swiss pharmaceutical giant, announced that impression130, a phase III clinical study for the evaluation of tumor immunotherapy (atezolizumab) combined with chemotherapy in the first-line treatment of triple negative breast cancer (TNBC), has reached the common end point of progression free survival (PFS) The results showed that, compared with chemotherapy alone (Abraxane), the first-line treatment of tecentriq + chemotherapy significantly reduced the risk of disease deterioration or death (PFS) in patients with metastatic or unresectable local advanced TNBC At the time of this interim analysis, total survival (OS) data in PD-L1 positive patients were encouraging Patients in this study will continue to be followed up until the next analysis In terms of safety, the safety of the combination of tecentriq and Abraxane is consistent with the known safety of each drug, and no new safety signal is found The results of the study will be presented at an upcoming medical conference and will be presented to regulators around the world, including the U.S Food and Drug Administration (FDA) and the European Drug Administration (EMA) Novartis and Gillette car-t drugs are supported by CHMP in Europe Recently, kymriah and yescarta, the car-t drugs under Novartis and Gillette, received the recommendation of CHMP Kymriah is a car-t immunocytotherapy, a revolutionary immunocytotherapy developed by the University of Pennsylvania and Novartis In August 2017, kymriah was officially approved by the US Food and Drug Administration (FDA) Kit Pharma's car-t therapy yescarta has also been approved by the U.S FDA for the treatment of certain types of large B-cell lymphoma in adults (these patients have received at least two other treatments, but no remission or relapse) Yescarta is the first FDA approved car-t therapy for specific non Hodgkin's lymphoma, and the second approved car-t therapy Geely acquired kit Pharma in a $11.9 billion acquisition last year Data source: Yaozhi data source: Biovalley, yaomingkant, Sina pharmaceutical