The world's best-performing new drugs in 2019: 7 listed in China, 2 with potential of tens of billions of dollars

It is admirable that these 10 billion dollar drugs have been on the peak after years of market trials, but there are also some new drugs that have been on the market in 2019 and have shown amazing market power soon after they are launched They either innovate the current clinical treatment or represent the new direction of disease cure, and their prospects are limitless Biktarvy (BIC / FTC / TAF) is a three in one AIDS drug approved for marketing by Geely on February 7, 2018 In less than two years of marketing, biktarvy has set an annual sales volume of nearly 5 billion US dollars, and has also set a new record for the annual sales volume of individual AIDS drugs Gilead launched a four in one cocktail therapy genvoya containing the integrase inhibitor etiravir and the enhancer cobicistat in 2015, in response to the competition of GlaxoSmithKline dolutegravir, while the component of biktarvy, bictegravir, is a more effective integrase inhibitor than dolutegravir and dotiravir, while removing the enhancer component, plus the safer TAF It only needs to be taken once a day, making biktarvy the best AIDS drug in history Biktarvy has been approved in China in August 2019, which will inject new growth momentum into its 2020 performance Biktarvy is also expected to become a $10 billion drug in the future Dupixent (dupilumab) is an antibody drug targeting IL-4 receptor α, which can combine and block IL-4 and IL-13 signals at the same time In March 28, 2017, it was approved by FDA for the first time for the treatment of adult atopic dermatitis At present, it has expanded the population to over 12 years old, and NDA for the population aged 6-11 years is under review In addition, dupixent is the first drug approved for the treatment of chronic rhinosinusitis with nasal polyps that are not fully controlled, and is the only biological product (phenotype free) approved for oral corticosteroid dependent asthma Dupixent has been listed for less than 3 years, and has been approved in 34 countries and regions including the United States, the European Union and Japan, with annual sales of $2.33 billion Sanofi also expects dupixent's annual sales to exceed $10 billion, taking into account subsequent indications and regional growth Dupixent has been included in the list of the second batch of clinically urgent overseas drugs in China It has submitted an application for listing on December 25, 2019 and is expected to be approved in the first half of 2020 Shinglix (herpes zoster vaccine) was approved on October 23, 2017, with sales reaching 784 million US dollars in 2018 and doubling to 2317 million US dollars in 2019 As soon as shingrix was launched on the market, it was officially recommended by the US CDC to vaccinate the over-50-year-old, which directly squeezed Zostavax, an old brand product of MSD, out of the US market In clinical research, shingrix can provide 90% of the immune protection effect for the over-70-year-old, while Zostavax's immune protection effect is between 18% and 70%, and the protection effect drops sharply with the increase of age In April 2019, GSK announced an investment of US $100 million to increase the production capacity of vaccine adjuvant in a factory in Canada Shinglix was approved in China on May 22, 2019 Imfinzi (durvalumab) was approved on May 1, 2017 At present, there are only two major indications of urothelial cancer and NSCLC However, in 2019, global sales reached $1.469 billion, an increase of 132.1% Under the situation that k-medicine is the best in the world and o-medicine growth is stagnant, i-medicine has achieved great success in the market with the precise positioning of stage III NSCLC, a segment of the population Tecentriq's sales volume in 2019 was CHF 1875 million (+ 142.9%), which is also very good Imfinzi was just approved by nmpa on December 6, 2019 Symdeko (ivacftor / tezacaftor) was approved on February 12, 2018 for the treatment of cystic fibrosis patients over 12 years old who carry two copies of f508del mutation or carry one copy of f508del mutation and any of the other 14 mutations In April 2019, symdeko's label was expanded and approved by the FDA for use in pediatric patients aged 6-11 to meet the mutation Symdeko's global sales reached $1.418 billion in 2019, selling blockbusters in an area of rare diseases Hemlibra (emicizumab kxwh) is a bispecific antibody drug developed by Roche for the treatment of hemophilia A, which was approved by FDA on November 16, 2017 Different from other alternative therapies that directly supplement coagulation factor VIII, hemlibra uses double specificity to agglutinate coagulation factor IXa and coagulation factor X together to restore the coagulation process of patients with hemophilia A A therefore, hemlibra can also play a good role in preventing bleeding for patients with hemophilia A who have factor VIII inhibitors in vivo It is the first one approved by FDA for treatment in recent 20 years The breakthrough of a new hemophilia A (about 1 / 3) drug containing factor VIII inhibitor, which can be injected once a week, has made hemlibra's revenue of $1.41 billion within two years after its launch Hemlibra was approved by nmpa on November 30, 2018 Tremfya (guselkumab) is a kind of monoclonal antibody drug targeting IL-23 Johnson & Johnson used a priority review voucher to accelerate its marketing to meet the challenge of IL-17A Tremfya was approved to be listed on July 13, 2017, and its sales revenue in 2019 has exceeded US $1 billion, forming the double insurance of Johnson & Johnson in the field of autoimmune diseases IL-23 product line Tremfya has been approved by nmpa on December 27, 2019 Fasenra (benralizumab), a McAb targeting IL-5 receptor, was approved by FDA on November 14, 2017, for the treatment of eosinophilic asthma Inhibitors of the IL-5 / il-5r signaling pathway are particularly effective in diseases characterized by hypereosinophils, such as eosinophilic asthma, chronic rhinosinusitis with nasal polyps Before fasenra, there were two other McAbs for IL-5, namely mepolizumab of GSK and reslizumab of Teva However, from the perspective of market performance, the global sales of fasenra in the second year of listing has reached $704 million, which is likely to become the best in class in this field Trelegy ellipta is the first three in one COPD compound drug developed and marketed by GSK in the world Three different mechanisms of action, i.e fluticasone furoate (ICS) / Lama / Laba, are loaded into the same inhalation device and released according to a fixed dose combination for patients to inhale The COPD drugs previously used in clinic are mainly ICs single prescription and the compound inhaler composed of ICs and bronchodilator However, in reality, about one third of patients with advanced COPD need to use three drugs with different mechanism of action at the same time to control the progress of the disease The emergence of trelegy meets this clinical demand, so it has reached 663 million US dollars within two and a half years of listing Trelegy has been approved by nmpa on November 6, 2019, and breztri aerosphere, the world's second triple COPD compound drug, has also been approved by nmpa on December 18, 2019 China has become the main battlefield of triple COPD compound drugs Vyndaqel (chlorobenzoic acid) is the first drug approved to treat ttr-pn in the world It was approved by the European Union in November 2011, but it was approved by the FDA nearly eight years later The sales revenue also increased significantly in 2019, reaching 473 million US dollars Attr-pn is a rare hereditary and fatal neurodegenerative disease The tetramer of TTR in patients is unstable, which leads to the abnormal folding of monomers and the deposition of amyloid, involving the motor, nervous system, heart, kidney, eye and other organs Vyndaqel fills in the gap of clinical treatment drugs of attr-pn, and has just obtained nmpa approval in 2020 / 2 / 5 as a clinically urgent drug Trikafta (ivacaftor / tezacaftor / elexacaftor) was approved by FDA on October 21, 2019 It was used to treat cystic fibrosis patients over 12 years old with at least one f508del mutation The coverage of vertex to cystic fibrosis patients was expanded to 90% Elexacaftor, an additional component of trikafta compared with symdeko, is a new generation of CFTR protein corrector, which is used to restore the function of CFTR protein carrying f508del mutation, so as to improve the respiratory function of CF patients It took less than three months from the submission of the application for listing to the final approval of the drug In addition, it realized a sales revenue of 420 million US dollars within two months of listing Aimovig (erenumab) is the first in class McAb targeting the calcitonin gene-related peptide receptor (anti cgrpr) Although it is only four months ahead of Teva and Eli Lilly's similar products (anti CGRP), it has been enough to turn the time advantage into market advantage Aimovig was approved on May 17, 2018, with sales revenue reaching US $409 million in 2019 Emgality's performance was equally impressive, with sales revenue of $162 million, reflecting the huge potential of the migraine drug market Zolgensma is the first gene therapy approved for the treatment of spinal muscular atrophy (SMA) It was first approved by the FDA on May 24, 2019, and sold for 361 million US dollars in less than seven months Compared with spinraza, Bojian's SMA drug, this drug can be cured only by one injection Although the price is as high as US $2.215 million, Novartis has adopted a flexible medical insurance payment policy At present, it has covered 97% of commercial insurance patients and more than 50% of Medicaid insurance patients in the United States 16 states in the United States have begun to screen newborns for SMA, accounting for 36% of the total number of newborns in the country, in order to achieve the goal of early detection and early use of zolgensma treatment Skyrizi (risankizumab) is a McAb targeting IL-23 In 2016, Albuquerque introduced the cooperative development from bringer Ingelheim and paid a down payment of $595 million Skyrizi was approved in Japan, the United States and the European Union at the beginning of 2019, covering major global markets This is the reason why skyrizi has received $355 million in its first year of listing, and it also makes Alberta see a new star of the future after Humira Ultomiris (ravulizumab) is a soliris upgrade product developed by alexion, a leading complement drug company, in the field of paroxysmal nocturnal hemoglobinuria (PNH) Ultomiris is also a complement C5 monoclonal antibody, but it is more long-acting than soliris It only needs to be injected intravenously every 8 weeks Compared with soliris, which is injected once every 2 weeks, the number of times of administration per year is reduced from 26 to 6 Ultomiris was approved by the FDA on December 21, 2018, and earned $339 million in revenue in 2019 Alexion announced on January 14 that it plans to launch a critical phase III study to evaluate ultomiris for the treatment of amyotrophic lateral sclerosis (ALS) Evenity (romosozumab) is the first in class monoclonal antibody targeting osteosclerotin, which can accelerate the formation of bone, reduce bone absorption, and play a role in the treatment of osteoporosis In 2010, Amgen listed Prolia, the world's first monoclonal antibody against osteoporosis, and the drug with the highest annual sales volume in the field of osteoporosis, reaching a new high of $2.672 billion in 2019 Evenity is the second McAb for osteoporosis, which was approved by FDA on January 8, 2019, with sales revenue of $189 million in that year It continues to consolidate its leading position in this field Piqray (alpelisib), the world's first commercially available PI3K α inhibitor for breast cancer treatment, achieved US $116 million in sales in less than seven months Pik3 α gene mutations account for about 40% of patients with HR +, HER2 - advanced or metastatic breast cancer At present, the drug has been applied for clinical application in China Poly (polyatuzumab vedotin) belongs to the first in class anti-cd79b antibody coupling drug CD79b protein in large