Take stock of the top 10 heavyweight drugs to be launched in 2017

[China Pharmaceutical network industry trends] in 2016, the pharmaceutical industry has achieved rapid development In drug research and development, pharmaceutical companies have also made every effort There will be more blockbuster drugs on the market in 2017 Let's take a look at the top 10 drugs with potential annual sales (photo source of top 10 heavyweight drugs to be listed in 2017: Baidu photo) 10 Zs-9 zs-9 is a potassium bonded zirconium silicate complex, which is used to treat hyperkalemia Hyperkalemia is a common side effect of some RAAS blockers It has different effects on arrhythmia and sudden cardiac death Hyperkalemia can also hinder the full use of RAAS blockers At present, the phase III clinical study of harmonize has been completed, involving 258 hyperkalemia patients related to chronic kidney disease, heart failure, diabetes or drugs blocking the Angiotension aldosterone system The results showed that 5 g of zs-9 per day could effectively reduce the serum potassium level of patients Meanwhile, the study showed that the safety of zs-9 was equivalent to that of placebo At the same time, the drug could reduce the serum potassium and maintain the blood potassium level, without causing hypokalemia The drug is expected to be approved by the US FDA in April next year 9 Shingrix shingrix is a vaccine for the prevention of herpes zoster, so the year 2017 of GSK is still worth looking forward to In October 2016, GSK submitted shingrix's biological product marketing license application to FDA to prevent shingrix from developing in adults over 50 years old This vaccine is considered to be a heavy product in GSK's recent industrial pipeline Current clinical data show that shingrix is superior to Zostavax, a vaccine of MSD, in terms of preventing shingrix in the elderly Last year, Zostavax's sales reached 7.5 Billion dollars, and given that shinrix is better than the former in clinical trials, it is estimated that sales will exceed this figure 8 Romosozumab of romosozumab Amgen is a humanized monoclonal antibody drug targeting at osteosclerotin Osteosclerotin is a kind of secretory glycoprotein, which is specifically expressed in bone cells It can inhibit the activity of osteoblasts and destroy the formation of bone tissue, which means that antagonizing osteosclerotin can alleviate the symptoms of osteoporosis Romosozumab was developed based on this principle At present, two phase III clinical studies have been completed, named structure study The results show that romosozumab is significantly better than tripeptide in the treatment of postmenopausal women with osteoporosis Another phase III clinical study called frame showed that compared with placebo group, romosozumab treatment group significantly reduced the risk of new vertebral fractures at 12 and 24 months of treatment, reaching the common primary end point of the study In addition, compared with the placebo group, the romosozumab treatment group significantly reduced the risk of clinical fracture at 12 months of treatment, reaching one of the secondary endpoints of the study, and the drug is expected to be approved for marketing in July 2017 　　 7、FF/UMEC/VI FF / umec / VI is a triple therapy for COPD GSK has submitted a new drug approval application NDA to FDA to seek approval of FF / umec / VI as a maintenance therapy for COPD patients The drug is administered through elipta dry powder inhaler of GlaxoSmithKline, which is composed of three treatments for COPD Common drugs: FF (fluticasone furoate, a inhaled corticosteroid), umec (umeclidinium, a long-acting muscarinic antagonist) and VI (vilanterol, a long-acting β 2 receptor agonist) GSK believes that the efficacy of triple drugs will surpass that of all these drugs This NDA submission is mainly based on the data of a phase III clinical project called fullil This study shows that FF / umec / VI is better than A-A in terms of lung function and health-related quality of life when it is used to treat COPD Symbicort, a heavyweight COPD product of sricom, has reached the common end point of the research The industry forecasts that the drug will become a heavyweight product with annual sales of US $1-2 billion 6 Dupilumab, developed jointly by Sanofi and regenerant, is an IL-4 / IL-13 signaling pathway inhibitor The over activation of this signaling pathway is the main cause of allergic dermatitis, asthma and other diseases At present, the clinical research on the treatment of allergic dermatitis has been completed and submitted to FDA for approval Clinical trial data published in June 2016 showed that the drug reached the primary and secondary end points of clinical trials Allergic dermatitis is a serious chronic skin inflammation, mainly manifested as severe pruritus, obvious eczema like change and dry skin Some patients continue for life, seriously affecting the quality of life of patients Clinical data showed that 39% of the patients in the experimental group (dupilumab 300mg / 1-2 weeks + TCS) had complete or partial regression of dermatitis symptoms, while only 12% of the patients in the control group (TCS) had the same effect, achieving the main end of the clinical experiment; at the same time, 64% of the experimental group achieved 75% of the remission of the rash severity index, while only 23% of the control group achieved this index It is expected that FDA approval will be obtained in March 2017 In addition, the third phase of clinical research on the treatment of asthma is also in progress 5 Ctl019 ctl019 is a new immunotherapy called car-t (chimeric antigen receptor-t) Different from the traditional small molecule or biological drugs, ctl019 is a kind of individualized treatment drug Its simple treatment process is as follows: firstly, T cells are isolated from the blood of patients, reprogrammed in vitro to enable them to effectively identify cancer cells, and then the T cells are returned to patients These T cells can effectively and specifically kill cancer cells As early as September 2014, FDA awarded ctl019 breakthrough therapy certification At present, the clinical research on the treatment of childhood acute myeloid leukemia (all) and diffuse large B cell lymphoma (DLBCL) has been completed Previously published clinical research results showed that the complete remission rate of car-t in pediatric patients with recurrent or refractory (R / R) acute lymphoblastic leukemia (all) was more than 90%; the total remission rate in adult patients with diffuse large B-cell lymphoma (DLBCL) was 47%; and the total remission rate in adult patients with follicular lymphoblastoma (FL) was 73% At present, Novartis has successfully realized the large-scale production of ctl019 The therapeutic effect and sales prospect of this drug are worthy of people's expectation It is expected to be approved by FDA in the second half of 2017 4 Avelumab avelumab is an all human monoclonal antibody targeting at PD-L1 PD-L1 inhibitors are in the ascendant in the field of anti-tumor drugs How can Pfizer fall behind in this respect? At present, there are as many as eight phase III clinical studies in progress, involving almost all common cancer research, lung cancer, gastric cancer, ovarian cancer and other cancers At present, the FDA and the European Union are reviewing the listing application of avelumab line 2 for the treatment of metastatic Merkel cell cancer PD-L1 antibody will be a kind of anti-tumor drug in the future Opdivo of BMS and keytruda of mosadong are two PD-1 inhibitors that have been on the market They are widely regarded as having annual sales of more than 5 billion dollars, even 10 billion dollars Avelumab is destined to be a blockbuster drug with annual sales of billions of dollars 3 Lie011 (ribociclib) ribociclib of Novartis is a CDK4 / 6 inhibitor, which is used to treat breast cancer It is considered by many analysts to be a drug that can weigh more than ibrance of Pfizer In June 2016, ribociclib was terminated prematurely in a phase III clinical trial called monaleesa-2, which significantly prolonged the progression free survival (PFS) of patients Monaleesa-2 is a randomized, double-blind, placebo-controlled, critical phase III clinical trial in 668 postmenopausal women with hormone receptor positive (HR +) and human epidermal growth factor receptor 2 negative (HER2 -) in 294 centers around the world The primary end point was progression free survival (PFS), and the secondary end points were total survival (OS), objective response rate (ORR), quality of life, safety and tolerance Based on the results of this study, in August 2016, the U.S FDA granted ribociclib breakthrough therapy certification, which is expected to be approved by the FDA in June 2017 2 Barictinib barictinib is a kind of Jak1 / JAK2 double effect inhibitor, which is used in the treatment of autoimmune diseases At present, it has completed clinical research JAK / STAT pathway is considered to play an important role in autoimmune diseases and some cancers JAK (Janus kinase) has three subtypes: Jak1, JAK2, JAK3 The downstream pathways and functions of each subtype are different As for which subtype of inhibitor can better treat rheumatoid arthritis, only clinical research can verify that baricinib can treat rheumatoid arthritis Many indicators of inflammation have surpassed xiumeile Lilly submitted a new drug application (NDA) to FDA in January 2016 It is expected that the drug will be available in January 2017 Barictinib was purchased by Lilly from Incyte in 2009 This transaction is a win-win result This is also a typical pattern in new drug research and development: small pharmaceutical companies are responsible for early research and development, but they are unable to carry out clinical research and marketing Pharmaceutical giants choose the ones with greater potential for venture capital investment If they are successfully listed, small companies will get milestone payments and share, and large companies will get huge sales profits, and both sides will get what they need 　　1、Sirukumab Sirukumab is an all human single antibody of IL-6 developed jointly by Johnson & Johnson and GSK IL6 and its receptor IL6R play an important role in the inflammatory response of rheumatoid arthritis Drugs targeting IL6 / IL6R are the hot spots of anti rheumatoid research Sirukumab has completed five global phase III clinical studies of rheumatoid arthritis and investigated two subcutaneous injection doses as single drug therapy , and compared with the efficacy and safety of traditional anti rheumatic and anti rheumatic drugs, the research report shows that the clinical effect of sirukumab is better than the current global rheumatoid drug xiumeile In September 2016, GSK and Johnson & Johnson respectively submitted their applications to the U.S FDA and the European Drug Administration (EMA) for the listing of rheumatoid arthritis, which is expected to be approved for listing in September 2017 Given the excellent clinical research data of sirukumab and the broad market of autoimmune diseases, combined with the joint promotion of the two major pharmaceutical companies, the annual sales of this drug will be billions of dollars Other.