[yaokejun] the first one in 20 years, is it sunny and the first? 11 kinds of drugs are on the market at an accelerated speed, and McAb is very eye-catching. A batch of "special and excellent" drugs have been approved, and class 1 new drugs have been approved

Highlights: 1.11 drugs are planned to be included in the priority review to accelerate the listing; Fuhong Hanlin, Baiji Shenzhou and Roche monoclonal antibody attract attention 2.9 years later, the approval of first class new drugs of Tonglian Pharmaceutical Co., Ltd was completed; 3 The approval of Lilai baraktinib tablet was completed; 4 Janssen dalaimumab injection showed "in the approval"; 5 New developments of important generic drugs of Zhengda Tianqing, Chongqing Yaoyou and Chongqing Huabang; 6 Johnson & Johnson entered China again with psoriasis drugs, and the market competition was upgraded; 7 For the first drug to treat PBC in 20 years, is it sunny? In the latest week (June 21-28), 14 drug acceptance numbers were announced by CDE to be included in the priority review, including 3 new drugs, 3 imported drugs and 5 generic drugs It is worth noting that Fuhong Hanlin, Baiji Shenzhou and Roche are among the three McAbs On June 26, the official website of CDE announced that the listing application of trastuzumab for injection declared by Shanghai Fuhong Hanlin was to be included in the priority review, and the listing will be accelerated According to the drug intelligence data, the drug application was accepted on April 29 It is a monoclonal antibody biological similar drug independently developed by Fuhong Hanlin, mainly used for the indications of metastatic breast cancer and gastric cancer In addition, the product is also in phase III clinical trials in China (excluding Hong Kong, Macao and Taiwan, the same below), Ukraine, Poland, Philippines and other countries At present, Roche's Herceptin ® is listed in China According to iqviachpa, the sales volume of Herceptin ® in China in 2018 is about 2.7 billion yuan In addition to Fuhong Hanlin, domestic enterprises and Sansheng Guojian have also applied for listing of similar drugs, which were undertaken on September 10, 2018, and have been included in the priority review Now there is a battle between the two sides, who will be the first to be listed, waiting for good news The application for tirelizumab injection, which is to be included in the priority review, is a newly declared indication in 2019 for the treatment of locally advanced or metastatic urothelial carcinoma (UC) patients who have been previously treated The first application was accepted by CDE in September 2018 for the treatment of R / rchl patients (included in the priority review) Tirelizumab (bgb-a317) is a monoclonal antibody against programmed death receptor-1 (PD-1) of human lgg4, which is still under development as a single drug therapy and combination therapy for a series of solid tumors and hematological tumors There are 3 domestic monoclonal antibodies of PD-1 approved in China, which are products of Junshi, Xinda and Hengrui, and Baiji Shenzhou will or will become the fourth approved enterprise On March 27, the domestic application for import of enmetrazumab for injection (kadcyla) of Roche was accepted, and now it is planned to be included in the priority review Kadcyla is a HER2 targeted therapy, which was approved by FDA on February 22, 2013 It is the first antibody drug conjugate (ADC) approved as a single preparation for the treatment of HER2 positive metastatic breast cancer patients who have received Herceptin and paclitaxel chemotherapy (alone or in combination) The drug is composed of trastuzumab and immunogen's cytotoxic DM1, which is delivered to HER2 positive breast cancer cells through a stable linker Since its listing, sales have increased gradually, with a slight decline in 2018, reaching 6.461 billion yuan This week, there are 39 new developments of reported drugs, including 2 new drugs, 3 imported drugs and 21 generic drugs Among them, 9 drugs were accelerated due to being included in the priority review Colamycin tablet is a kind of macrolide antibiotic for the treatment of bacterial infection It has three national patents It was developed by Institute of pharmaceutical biotechnology, Chinese Academy of Medical Sciences, and then transferred to Shenyang Tonglian Pharmaceutical Group In September 2010, the compound was jointly declared by the Institute of pharmaceutical biotechnology, Chinese Academy of Medical Sciences, Shenyang Tonglian and Beijing Shouke group as a new class 1.1 drug The drug applied for supplementary application in 2015 and reexamination application in 2017, and now the review is finally completed Li Lai Ba Rick TiNi On June 26, Lili's baricitinib tablet showed "approval completed - to be prepared" It is a selective and reversible Jak1 and JAK2 inhibitor, which is taken orally once a day It is clinically developed for the treatment of a variety of inflammatory and autoimmune diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (as), psoriasis, atopic dermatitis, pedigree Systemic lupus erythematosus, ulcerative enteritis (UC), alopecia areata, etc In February 2017, barricatinib was approved by the European Union as a single drug or combination of methotrexate for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have insufficient or intolerable response to one or more disease modifying antirheumatic drugs (DMARD) It is also the first JAK inhibitor approved by the European Union for the treatment of rheumatoid arthritis At present, domestic JAK inhibitors have been listed as Pfizer's tofacib tablets On June 21, Janssen's daratumumab injection showed "under approval." Daratumumab was initially developed by genmab company, and then authorized to Janssen (a subsidiary of Johnson & Johnson) On November 16, 2015, it was approved by the US Food and Drug Administration (FDA) for listing and sold by Janssen in the US market The product name is darzalex Daratumumab is an anti-CD38 monoclonal antibody, which can bind CD38 on multiple myeloma cells and activate the immune system, thus killing tumor cells The indication approved by the drug is multiple myeloma that has been treated more than three times On June 26, Chongqing Yaoyou venlafaxine hydrochloride tablet's application for listing of four new generic drugs of venlafaxine hydrochloride declared by Chongqing Yaoyou showed "approval completed - Certificate to be prepared" The application was included in the drug clinical trial data self-examination and verification varieties on June 6, 2016; on November 22, 2017, it was included in the priority review on the basis of "production of the same production line, listing in the United States in 2015" Venlafaxine hydrochloride is a kind of psychoactive drug, which has two-way effects of anti anxiety and anti depression It is mainly used in the treatment of various kinds of depression with anxiety depression and generalized anxiety disorder At present, there are 9 enterprises holding capsule approval, 2 enterprises holding tablet approval and 1 enterprise holding sustained-release tablet approval At present, there is no enterprise that has passed the consistency evaluation This time, if approved by the pharmaceutical friends, they will take the lead in the market On June 24, Zhengda Tianqing salmeterol ticasone powder inhaler showed "approval completed - to be prepared" The indication of the drug was in the form of combination (bronchodilator and inhaled corticosteroids) for regular treatment of reversible obstructive airway disease, including asthma in adults and children At present, there are only GlaxoSmithKline imported drugs in the domestic market On June 26, linezolid tablets of Chongqing Huabang Pharmaceutical Co., Ltd showed "approval completed - to be certified" The application was included in the priority review on July 11, 2017 on the basis of "drug production application one year before the expiration of the patent" Developed by Pfizer, the drug was first approved by the U.S Food and Drug Administration (FDA) on April 18, 2000, and then approved by PMDA on April 4, 2001, under the trade name of zyvox It is applicable to the following infections caused by susceptible Gram-positive bacteria in adults and children: nosocomial pneumonia, community-acquired pneumonia, complex skin or skin soft tissue infection, including diabetic foot infection without osteomyelitis, non complex skin or skin soft tissue infection and vancomycin resistant enterococci infection At present, in addition to imports, there are no domestic tablets on the market, and 6 domestic enterprises hold the approval documents for the production of linezolid glucose injection Among the newly approved drugs reported this week, 20 acceptance numbers have been accepted, including 2 new drugs, 4 imported drugs and 9 generic drugs On June 22, Janssen guselkumab injection application for import of guselkumab injection declared by Janssen under Johnson & Johnson was accepted The drug was approved by FDA on July 13, 2017 for the treatment of patients with moderate to severe plaque psoriasis These adult patients can be used for systemic therapy or phototherapy Guselkumab is the first approved biologicaltherapy that selectively targets IL-23, a cytokine that plays a key role in the pathogenesis of plaque psoriasis On June 24, posaconazole injection declared by Hangzhou AoYa was accepted Posaconazole was jointly developed by mosadong company It was first approved by the European Drug Administration (EMA) on October 25, 2005, and then approved by the U.S Food and Drug Administration (FDA) on September 15, 2006, under the trade name of noxafil The drug is suitable for the treatment of refractory fungal infections (such as invasive Aspergillus, Fusarium, yeast, Mycobacterium, coccidiosis) It is the first time for the treatment of thrush and the prevention of serious fungal infections At present, only imported preparations of mercksharp & Dohme Ltd, posaconazole enteric coated tablets and posaconazole oral suspension, are available in China, and there is no injection on the market Posaconazole sales reached $742 million in 2018 On June 25, the application for listing of Zhengda Tianqing Aobei cholic acid tablet was accepted Octalva is a new generation of therapeutic drug for primary biliary cirrhosis (PBC) developed by intercept pharmaceutical company in the United States Intercept was first approved by FDA in the United States on May 27, 2016 and approved by the European Union on December 12, 2016 It is the first drug approved to treat PBC in the past 20 years 。 Because PBC is a rare disease, obecholate was recognized as an orphan drug by the orphan drug Council (COMP) of the European Drug Administration in 2010 As an incentive measure, orphan drugs can obtain the exclusive market right for ten years The sales volume of listed companies reached 18.2 million dollars in 2016 and 177.8 million dollars in 2018, almost 10 times higher At present, the drug has not been listed in China, only Nanjing Zhengda Tianqing has applied for generic drug listing In addition, obecholate has been proved to be effective in the treatment of nonalcoholic steatohepatitis (NASH), and FDA has awarded it a breakthrough treatment On February 19, 2019, intercept company announced that obacillic acid (OCA) reached the main end point in a three-phase test of nonalcoholic steatohepatitis (NASH), significantly improved liver fibrosis, and is expected to become the first new drug for the treatment of NASH Data source: Pharmaceutical intelligence data part information reference: relevant enterprise announcement, relevant enterprise news statement: this point of view only represents the author, does not represent the pharmaceutical intelligence network position, 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.