[drug Kajun] drug review week: new drugs for rare lung diseases have obtained FDA's breakthrough drug qualification; Hua Hai An lisentan tablets have been approved for listing and newly collected; Hua Hai and mengke jointly reported the first product

Highlights: the first GIST patients with specific genomic characteristics were approved for precise therapy; the FDA granted molgradex the qualification of breakthrough therapy in the treatment of pulmonary alveolar proteinosis; Hua Hai An lisentan tablets were collected in the local market; nmpa-2019 ended perfectly, and the first pattern of PD-1 has been formed; the first antibacterial new drug of mengke medicine was reported by CDE The latest approval trend of FDA is just beginning in 2020, with continuous good news from FDA Orphan drugs have been approved and new therapies for rare diseases have been recognized Ayvakit, an orphan drug, was approved by the FDA on January 10 The U.S FDA announced that the ayvakit (avapritinib) developed by blueprint medicine company was approved for marketing to treat adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) Ayvakit (avapritinib) is a powerful high-specific kit and PDGFRA mutant kinase inhibitor The new drug has been awarded breakthrough treatment certification by FDA, as well as fast track qualification, orphan drug qualification and priority review qualification This is the first approved treatment for GIST patients with specific genomic characteristics, according to a blueprint press release Last year, cornerstone pharmaceutical entered into an exclusive cooperation and licensing agreement with blueprint medicines to obtain the rights and interests of ayvakit and two other specific kinase inhibitors in clinical development and promotion in Greater China Molgradex won the FDA breakthrough treatment certification, which was granted by the FDA of the United States to the drug under research, molgradex breakthrough treatment certification, for the treatment of patients with autoimmune alveolar protein deposition (APAP) Molgradex is a kind of inhalation preparation of recombinant GM-CSF It has been awarded orphan drug qualification by FDA and European drug administration to treat PAP patients Currently, molgradex is also being developed to treat patients with pulmonary infection caused by non tuberculosis mycobacterium (NTM) The new trend of nmpa approval: 48 CDE applications for production acceptance No (36 varieties) were reviewed and approved this week, with 34 varieties in "issued" status and 2 varieties in "under approval" status, coming to market See the following table for details: the formation of "4 + 2" competition situation of domestic PD-1 monoclonal antibody is accompanied by the listing of bleuzumab injection in Shenzhou, Baiji The domestic PD-1 competition pattern has been determined, the first echelon, "2 + 4" mode: 4 domestic drugs and 2 imported drugs With the maturity of data, domestic monoclonal antibody PD-1 shows excellent clinical efficacy, and immune related safety events are gradually becoming the focus of clinical development and marketing We look forward to the approval of the second tier in 2020, which will bring more possibilities for cancer patients Qilu Pharmaceutical Co., Ltd makes efforts in the dual market and seizes the original research market Qilu has issued tacrolimus ointment with 6 categories of generic drugs and bevaludine for injection with 3 categories of generic drugs If it is successfully approved for production, it will become the second injection product of the company that is deemed to have passed the consistency evaluation At present, bevaludine for injection has not been evaluated by any enterprise The consistency evaluation application submitted by xinlitai and Shuangcheng pharmaceutical industry is under review Medium In recent years, with the impact of domestic generic drugs, the market share of tacrolimus continues to decline Among the domestic enterprises, Hangzhou, China, the United States and East China Pharmaceutical Co., Ltd rank in the forefront It remains to be seen what changes will be brought about by Qilu's entry into the Bureau Hua Hai'an lisentan tablet was approved and collected in the bureau! Anlishentan tablet is mainly used for the treatment of pulmonary hypertension patients (who group 1) with WHO grade II or III symptoms, in order to improve exercise ability and delay clinical deterioration As one of the 33 kinds of drugs that have been determined to be purchased in a new round of centralized procurement, Huahai is deemed to have passed the consistency evaluation and qualified to enter the Bureau It is possible to compete with other manufacturers in the national centralized procurement bidding on January 17 At present, the competition of the national centralized purchase of ansentan tablets is as follows: this week, the new acceptance of CDE review and approval (January 3-10, 2020), CDE newly reported 27 product specifications of production acceptance number, involving 23 varieties; only one new drug, the first antibacterial new drug of UNITAR medicine, kangtazolamine tablets, has the following specific contents: kangtazolamine tablets Contazolamine is an oral oxazolidinone antibacterial drug, which is the first new antibacterial drug of mengke medicine It is designed to treat infections caused by resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE), and provide doctors and patients with a safer and more tolerable treatment option than the existing oxazolidinone drugs It is worth mentioning that in September 2018, cantazomide obtained the fast track qualification granted by the US FDA for the treatment of acute bacterial skin and skin tissue infections According to the database of drug registration and acceptance, at present, the same kind of new drugs approved for marketing are linezolid and tertiazem, and at present, linezolid generic drugs of hausen and Huabang pharmaceutical industry have been listed in China This week, mengke pharmaceutical and Huahai pharmaceutical jointly declared the listing of the drug, which is expected to bring new gospel to domestic patients Data source: drug intelligence data, enterprise announcement and other online public data information source: drug intelligence data, enterprise announcement and other online public information With high integration, in-depth analysis and intelligent intelligence of pharmaceutical intelligence data, the intelligent tool platform for pharmaceutical data has been specially built for VIP enterprise customers, covering core data such as drug registration, hospital sales, drug reports, enterprise reports, clinical trials, drug listing, drug bid winning, device listing, drug sales, etc., and providing all-round access to enterprise users from production, research and development, sales, and use And other information channels in various links to help enterprises in R & D and decision-making Mengmeng statement: this view only represents the author and does not represent the position of yaozhi.com You are welcome to exchange and supplement in the message area If you need to reprint, please be sure to indicate the author and source of the article.