"Bombshell" potential! 12 new drugs worth watching this year
Last Update: 2020-06-19
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The latest report "the most noteworthy drug forecast 2018" released by sinopharm.com on April 19 predicted 12 new heavyweight drugs to be launched in 2018 (already or likely to be launched), and the sales of these new drugs will reach the heavyweight bomb level within 5 years< br / > < br / > more than half of the 12 drugs have been identified by priority review, breakthrough therapy or fast track review, among which 5 are first inclass new drugs, 4 are orphan drugs, and only one anti-tumor drug has been listed, namely, erlada (aplutamide) of Johnson & JohnsonThe occurrence of coagulation factor Ⅷ inhibitor is the most serious and challenging complication in hemophilia treatmentHemlibra has been approved for < br / > with factor Ⅷ inhibitor or for prevention of haemorrhage in adult hemophilia A to prevent or reduce the occurrence of haemorrhagic eventsThe approval of the drug has brought the first new treatment for the disease in 20 yearsAt present, other drugs available in the field are mainly FEIBA (prothrombin complex) of shire and novo seven (recombinant coagulation factor ⅶ a) of nordenod< br / > < br / > in fact, the time limit for FDA to make approval decision on hemlibra is February 2018, but because of priority review, breakthrough therapy and orphan drug certification, FDA approved hemlibra in advance in November 2017< br / >In February 2018, the European < br / > authority (EMA) approved hemlibraThe product is expected to land in the European Union and Japan markets at the same time in the yearThe sales volume is expected to reach 496 million dollars in 2018, 1457 million dollars in 2019 and 402 million dollars in 2022< br / > < br / > after 2018, FEIBA and NovoSeven are likely to see a significant decline in sales due to hemlibra's competitionThe biggest impact is that hemlibra will be approved for use in hemophilia A without limiting factor Ⅷ inhibitor, which will greatly expand its scope of use< br / > < br / > hemlibra's new mechanism of action, excellent efficacy and potential once a month administration frequency will have a huge impact on the market pattern of factor ⅧDespite the black box warning (FDA's serious warning for potentially serious < br /), the hemlibra will still lead the hemophilia treatment market beyond 2020< br / >< br / > < br / > the competition between Gilead and GSK in the anti HIV market is very fierce In 2014, GSK launched triumeq, whose success brought it back to the anti HIV market In response, Geely has launched several best combination solutions with better security, including genvoya launched in 2015, odefsey and descent launched in 2016, which help Geely regain its lost market share < br / > < br / > in January 2018, GSK launched dulutway / ribavirin, which is the best combination of tivicay and ribavirin Biocegravir is as safe and effective as tivicay, and is a real once a day integrase inhibitor as tivicay, without any additional enhancers < br / > < br / > < br / > it is estimated that biktarvy's sales will reach US $896 million in 2018, rapidly rise to US $2.282 billion in 2019 and US $3.716 billion in 2022 < br / > < br / > ozempic, a GLP-1 analogue administered once a week by Novo Nordisk, was approved in December 2017 for the treatment of type 2 diabetes and was launched in February 2018 < br / > However, the data of sustain7 released in 2017 shows that ozempic's hypoglycemic effect and weight reduction effect are better than that of trulicity < br / > Because ozempic has obtained positive evidence of cardiovascular benefits, it will press on trulicity to help Novo Nordisk regain GLP-1 market share Nevertheless, trulicity will remain the leader in the GLP-1 market in 2022, with forecast sales of $4099 million, Novelli of $3912 million and ozempic of $3469 million < br / > Oral GLP-1 can replace small molecule hypoglycemic drugs at an earlier stage of treatment, which can not only reduce blood sugar more effectively, but also benefit cardiovascular system In addition, somaluptide is also carrying out clinical research on obesity and non-alcoholic fatty liver (NASH), which will pose a threat to competitive products in an all-round way < br / > < br / > the castration resistance prostate cancer (CRPC) market is dominated by Johnson & Johnson's new generation of oral antiandrogens zytiga (abitrone) and antandi (enzalutamide) of Astaire / Pfizer However, both products are only approved for metastatic CRPC Erlada (R & D of Johnson & Johnson), the second generation of new antiandrogen drug approved in mid February 2018, took the lead and became the first therapy in the field of non metastatic CRPC < br / > Still, erlada has a first mover advantage, entering the U.S market shortly after its approval, with sales expected to reach the blockbuster level by 2020 < br / > < br / > in addition to non metastatic CRPC, erlada has the potential to be approved for other indications, including metastatic hormone sensitive prostate cancer (Titan test), locally high-risk / locally advanced prostate cancer (atlas test) and the combination of abiolone in the treatment of non chemotherapy metastatic CRPC, which will be the driving force for its rapid growth in sales < br / > It is the first new type of herpes zoster vaccine in more than ten years Zostavax of mosadong is the only approved herpes zoster vaccine by FDA < br / > < br / > the prevention effect of Zostavax will gradually decline with the passage of time, while shingrix can continue to provide protection, and it is still effective for Zostavax to prevent failure population Although only one dose of Zostavax and two doses of shinglix are needed, the Centers for Disease Control and prevention in the United States officially recommended the use of shinglix to vaccinate people over the age of 50 in January 2018 < br / > < br / > within two years after its launch, shingrix is expected to replace Zostavax as the market leader of herpes zoster vaccine It is estimated that shingrix's sales will reach 537 million US dollars in 2019, while Zostavax's sales will drop to 492 million US dollars from 765 million US dollars (peak) in 2014 In addition, shinglix's sales will exceed $1 billion after 2021 < br / > < br / > the indications of patisiran's application are hereditary PTH related amyloidosis If it is approved successfully, it will become the first RNA interference drug (RNAi) in the United States Prior to this, FDA has granted patisiran priority review, fast track and breakthrough therapy identification, and PDUFA period is August 2018 On the European side, EMA has awarded paisiran the qualification for accelerated review The product is expected to land in the United States and Europe at the same time by the end of 2018 and become a < br / > therapy for hereditary PTH related amyloidosis < br / > < br / > at present, the standard therapy for this disease is liver transplantation, but this therapy has the risks of operation, acute liver rejection, infection, high requirements for clinical conditions, and can only be treated for patients who can receive intervention < br / > Epidiolex (plant extracted cannabis diphenol) from GW pharmaceutical is expected to become the first antiepileptic drug containing cannabis diphenol FDA has granted it the priority review qualification, and PDUFA period is June 2018 < br / > < br / > in addition, the European listing application (MAA) has also been submitted Because epidiolex is very persuasive to the data of Dravet syndrome and Lennox Gastaut, the probability of approval is very high < br / > This barrier limits the use of all marijuana extraction drugs, particularly in the United States, where there are strict guidelines for their use < br / > Epidiolex is very promising, it can pave the way for the medical use of cannabis extract < br / > < br / > aimovig (erenumab) may be the first listed CGRP inhibitor Getting the first listing right is crucial for aimovig, as competition for two mAbs from the same target is looming Lilly's galcanezumab (once a month) and TIWA's freeezumab (once a month or once every three months) have submitted listing applications to FDA Alder's eptinezumab (once every 3 months) is still in phase III clinical trials, but the response rate in some patients is as high as 100% The product is expected to be put on the market in 2018 < br / > Because of the strong clinical data, the sales of eptinezumab will increase rapidly, and it is expected to reach 946 million US dollars in 2023 < br / > < br / > it is worth noting that there will be competition for oral CGRP inhibitors in the future, such as atogepant of Elgin and rimegepant of biohaven Because of the advantages of oral administration, these products will take a large share of the market < br / > < br / > the listing application of laadelumab, a new hereditary angioedema drug, has been submitted, and it has obtained the priority review in the United States and the accelerated review qualification in the European Union < br / > < br / > cinryze (human complement C1 esterase inhibitor) is the main product to prevent angioedema at present, but the main disadvantage is that it needs intravenous injection The first subcutaneous product is haegarda, a complement C1 esterase inhibitor approved for marketing by CLS Bellin in 2017 Although the drug has a first-time advantage, lanadelumab will still dominate the first-line prevention market of hereditary angioedema, and because of its superior efficacy and convenient administration, the amount of drug will increase significantly < br / > < br / > although haegarda and cinryze are also Bi weekly therapies, lanadelumab is expected to achieve once a month administration on the basis of Bi weekly administration At the same time, lanadelumab's injection dose is less than haegarda's and takes less time to inject, which will give it a competitive advantage to obtain huge sales revenue < br / > < br / > cinryze's sales are expected to be $665 million in 2018, but will decline to $283 million in 2022, while lanadelumab's sales will be
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