Week of drug review: Breakthrough of new lung disease drugs: anlishentan tablets approved for market

Attention: The first gist precise therapy with specific genomic characteristics was approved; FDA granted molgradex the qualification of breakthrough therapy in the treatment of pulmonary alveolar proteinosis; Huahai'an lishengtan tablet was put into local centralized mining; Nmpa-2019 ended perfectly, and PD-1 has become the first pattern; The first antibacterial new drug of mengke medicine was reported by CDE The year 2020 has just begun, and the FDA has received continuous good news Orphan drugs have been approved and new therapies for rare diseases have been recognized On January 10, the U.S FDA announced that it approved the launch of ayvakit (averitinib) developed by blueprint medicine company for the treatment of 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 The US FDA has awarded the drug molgradex as a breakthrough therapy 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) This week, 48 CDE applications (36 varieties) for production acceptance number review and approval were updated; 34 of them were in "issued" status, and 2 of them were "under approval" and will be listed soon See the following table for details: With the launch of bleuzumab injection in China, the competition pattern of PD-1 in China 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 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 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 situation of the national centralized mining of anlishengtan tablets is as follows: This week (January 3-10, 2020), CDE added 27 new product specifications with production acceptance number, involving 23 varieties; only one new drug, the first new antibacterial drug of mengke medicine, kangtazolamine tablets, is as follows: 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.