Top 10 heavy drugs coming soon in 2017
10, ZS-9 ZS-9 is a potassium binder zirconium silicate complex used to treat hyperkalemia. Hyperkalemia is a common side effect of some RAAS blockers, with varying degrees of arrhythmia and sudden cardiac death, and hyperkalemia can also prevent the complete use of RAAS blockers. The drug has now completed a phase III clinical study, and a phase III clinical trial called HARMONIZE has included 258 patients with hyperkalemia associated with chronic kidney disease, heart failure, diabetes, or an angiotensin aldosterone system. The results showed that 5 g of ZS-9 per day can effectively reduce the serum potassium level of patients, and the study showed that the safety of ZS-9 is comparable to that of placebo, and the drug can lower serum potassium and maintain blood potassium levels without causing Hypokalemia. The drug is expected to be approved by the US FDA in April next year. 9, Shingrix Shingrix is ​​a vaccine used to prevent herpes zoster, so GSK's 2017 is still worth looking forward to. In October 2016, GSK submitted a Shiningrix biologics marketing approval application to the FDA for the prevention of herpes zoster in adults over 50 years old. This vaccine is considered to be a heavy product in GSK's recent industrial pipeline. Current clinical data indicates that In the prevention of herpes zoster in the elderly, Shingrix is ​​superior to Merck's vaccine Zostavax, and last year Zostavax's sales reached $750 million. Given that Shinglix is ​​superior to the former in clinical trials, it is estimated that sales will exceed this figure. 8, Romesozumab Amgen's Romosozumab is a humanized monoclonal antibody drug that targets osteosclerosis proteins. Sclerostin is a secreted glycoprotein that is specifically expressed in osteocytes and inhibits the activity of osteoblasts, thereby destroying the formation of bone tissue, which means antagonizing osteosclerosis. It can alleviate the symptoms of osteoporosis, and Romosozumab was developed based on this principle. Two phase III clinical studies have been completed, and the results of the STRUCTURE study show that Romosozumab is superior to teriparatide in the treatment of postmenopausal women with osteoporosis. Another phase III clinical study, FRAME, showed a significant reduction in the risk of new vertebral fractures at 12 and 24 months of treatment in the Romosozumab group compared with the placebo group. Common primary end point. In addition, the Romosozumab treatment group had a significantly lower risk of clinical fractures at 12 months of treatment compared with the placebo group, reaching one of the secondary endpoints of the study, which is expected to be approved for marketing in July 2017. 7, FF / UMEC / VI FF/UMEC/VI is a triple therapy for chronic obstructive pulmonary disease. GSK has submitted a new drug approval application to the FDA for NDA, seeking approval for FF/UMEC/VI as a maintenance therapy for chronic obstructive pulmonary disease (COPD). In the treatment of patients with chronic bronchitis and emphysema, this drug is administered by GlaxoSmithKline's Ellipta dry powder inhaler, which is composed of three of the most common drugs for the treatment of COPD: FF (Fluticasone furoate, fluticasone furoate) , an inhaled corticosteroid), UMEC (Umeclidinium, a long-acting muscarinic antagonist) and VI (Vilanterol, a long-acting beta 2 receptor agonist). All three drug ingredients have been approved as single or dual drugs. GSK believes that the effects of triple drugs will outweigh all of these drugs. The submission of this NDA is based on a phase III clinical project called FULTIL. According to the data, the study showed that FF/UMEC/VI was superior to AstraZeneca's heavy COPD product, Symbicort, in the treatment of COPD. end. The industry predicts that the drug will become a heavy product with annual sales of $1 billion to $2 billion. 6, Dupilumab Dupilumab, jointly developed by Sanofi and Regenerating Element, is a signaling pathway inhibitor of IL-4/IL-13. Over-activation of this signaling pathway is the main cause of allergic dermatitis, asthma and other diseases. Clinical studies of the treatment of dermatitis have been submitted to the FDA for approval. Clinical trial data published in June 2016 showed that the drug reached the primary and secondary endpoints of clinical trials. Atopic dermatitis is a serious chronic skin inflammation, mainly characterized by severe itching, obvious eczema-like changes and dry skin. Some patients continue to live for a lifetime, seriously affecting the quality of life of patients. Clinical data showed that 39% of the patients in the test group (dupilumab 300mg/1-2 weeks + TCS) had complete regression or partial regression of dermatitis symptoms, while only 12% of the control group (TCS) achieved the same effect. The main end of the clinical trial; 64% of the experimental group achieved a 75% reduction in the rash severity index, while only 23% of the control group reached this target. It is expected to be approved by the FDA in March 2017, and a phase III clinical trial of this drug for asthma is also underway. 5, CTL019 CTL019 is a novel immunotherapy called chimeric antigen receptor-T (CAR-T). Unlike traditional small molecules or biopharmaceuticals, CTL019 is an individualized treatment. The simple treatment process is to first isolate T cells from the patient's blood and reprogram T cells in vitro to enable them to Effectively identify cancer cells, and then return T cells to the patient, these T cells can effectively kill cancer cells. As early as September 2014, the FDA granted CTL019 breakthrough therapy approval. Clinical studies have been completed to treat children with acute myeloid leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL). Previously published clinical studies have shown that CAR-T has a complete response rate of more than 90% in pediatric patients with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL); for diffuse large B-cell lymphoma (DLBCL) The overall response rate was 47% in the adult patient group and 73% in the adult patient group with follicular lymphoma (FL). At present, Novartis has successfully realized the large-scale production of CTL019. The therapeutic effect and sales prospects of this drug are worthy of people's expectation. It is expected to be approved by the FDA in the second half of 2017. 4, Avelumab Avelumab is a fully human-derived monoclonal antibody that targets PD-L1. PD-L1 inhibitors are now in the forefront of anti-cancer drugs. How can Pfizer lag behind in this regard? The drug currently has as many as eight phase III clinical trials in progress, involving almost all common cancer studies, lung cancer, stomach cancer, ovarian cancer and many other cancers. Currently, the FDA and the European Union are reviewing Avelumab 2-line treatment for metastatic dysfunction. Application for marketing of Kerr cell carcinoma. PD-L1 antibody will be the best-selling anti-tumor drug in the future. BMS Opdivo and Merck's Keytruda are two PD-1 inhibitors already on the market. They are widely optimistic that annual sales can exceed $5 billion, or even 100. A billion dollars, Avelumab is also destined to be a heavy drug with annual sales of billions of dollars. 3, LEE011 (Ribociclib) Novartis' Ribociclib is a CDK4/6 inhibitor used to treat breast cancer, which is considered by many analysts to be a heavyweight drug that can be compared to Pfizer's Ibrance. In June 2016, Ribociclib was prematurely terminated in a phase III clinical trial called MONALEESA-2 because it significantly prolonged progression-free survival (PFS). MONALEESA-2 is a randomized, double-blind, placebo-controlled, phase III clinical trial with 668 hormone receptor-positive (HR+) and human epidermal growth factor receptor-negative (HER2-) 294 centers worldwide In postmenopausal women patients. The primary end point was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), objective response rate (ORR), quality of life, safety, and tolerability. Based on the results of this study in August 2016, the US FDA granted Ribociclib a breakthrough therapy approval, which is expected to be approved by the FDA in June 2017. 2, Baricitinib Baricitinib is a JAK1/JAK2 double-effect inhibitor for the treatment of autoimmune diseases, and it has now completed clinical research. The JAK/STAT pathway is thought to play a major role in autoimmune diseases and certain cancers. JAK (Janus kinase) has three subtypes: JAK1, JAK2, and JAK3, each of which has different downstream pathways and functions. As for which subtype of inhibitor can better treat rheumatoid arthritis, it has only been verified by clinical studies. Baricitinib surpassed Xiu Mei Le in many indicators of rheumatoid arthritis. In January 2016, Lilly submitted a new drug application (NDA) to the FDA. It is expected that the drug will be available in January 2017. Baricitinib was purchased from Incyte in 2009. This transaction is a win-win result. This is also a typical routine in the development of new drugs: small pharmaceutical companies are responsible for pre-development, but are unable to conduct clinical research and promotion sales. The pharmaceutical giants choose the risk investment with great potential. If it is successfully listed, the small company will receive milestones and share. Large companies get huge sales profits, and both sides take what they need. 1. Sirukumab Sirukumab is an IL-6 full-human single antibody developed by Johnson & Johnson and GSK. IL6 and its receptor IL6R play an important role in the inflammatory response of rheumatoid arthritis. The drug targeting IL6/IL6R is an anti-class. At the hot spot of rheumatology research, Sirukumab has completed five global phase III clinical studies of rheumatoid arthritis, investigating the efficacy and safety of two subcutaneous doses as monotherapy and traditional anti-rheumatic drugs. For comparison, the study shows that Sirukumab has a clinical effect that exceeds the current world's best-selling rheumatoid drug, the beauty. In September 2016, GSK and Johnson & Johnson submitted a listing application for the treatment of rheumatoid arthritis to the US FDA and the European Medicines Agency (EMA) respectively. It is expected to be approved for marketing in September 2017, given Siriumab's excellent clinical research data and The broad market for autoimmune diseases, coupled with the joint efforts of two giant pharmaceutical companies, will have annual sales of billions of dollars.
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