The market of newly approved antineoplastic drugs is surging

With the acceleration of drug review and approval, a number of major imported new drugs have been launched this year Among them, the main imported tumor products are: pezopanil tablets of Glaxo, afatinib tablets of bringlingham, verofinil tablets of Roche, oxitinib tablets of AstraZeneca, regofinil tablets of Bayer; hepatitis C products are: dalatavir tablets of Bristol Myers Squibb, ashuribe soft capsules; diabetes products are: daggliptin tablets, saggliptin metformin sustained-release tablets; Anti rheumatism products include Pfizer's tuofatipu and so on A large number of the above-mentioned imported new drugs have been approved, which will cause the market pattern of tumor, hepatitis C, diabetes, hypertension and other fields to quietly change The following is mainly to sort out the recently approved imported tumor products   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans-serif; font-size: 16px; line-height: 25.6px; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); Box sizing: border box! 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Im portant; "> global sales of pazopanib soared Pazopanib, developed by GlaxoSmithKline, was approved by FDA on October 19, 2009 and listed under the trade name of" votrient " This product is mainly suitable for the treatment of advanced renal cell carcinoma and soft tissue sarcoma Votrient is an oral drug that interferes with the formation of new blood vessels needed for the growth and survival of solid tumors According to the statistics of relevant data, the sales volume of pezopanil in 2011 was US $155 million, 2015 was US $565 million, 2016 was US $729 million, an increase of 29.0% over the same period From the perspective of sales in 2011-2016, the product maintained a rapid growth rate According to the data of the drug examination center, pezopanil and tablets of GlaxoSmithKline were approved by CFDA on February 21, 2017 The product is called "weiquante" It is mainly used for the first-line treatment of advanced renal cancer (ARCC) The dosage form is tablet, and the specification is 200mg and 400mg At present, there are six enterprises applying for pezopanil tablets in China, including Qilu Pharmaceutical Co., Ltd., Jiangsu Haosen Pharmaceutical Co., Ltd., Zhengda Tianqing Pharmaceutical Co., Ltd., Jiangsu aosaikang Pharmaceutical Co., Ltd., Yangtze River Pharmaceutical Co., Ltd   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans-serif; font-size: 16px; line-height: 25.6px; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); Box sizing: border box! 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Im portant; "> afatinib is a new generation of oral small molecule tyrosine kinase inhibitor developed by Berlin Ingelheim company The product has been registered and approved by FDA for the first time on July 12, 2013, and the trade name is "gilotif" It is mainly used for the treatment of mutant non-small cell lung cancer and HER2 positive advanced breast cancer patients, and it was approved by the European Commission (EC) on September 25, 2013 At present, the United States and Europe have accepted the registration application of afatinib for the treatment of advanced lung squamous cell carcinoma patients after first-line chemotherapy It has passed the orphan drug certification of FDA, and is intended to grant the unique status of products for the treatment of rare diseases At present, the product has been approved for marketing in more than 70 countries, and is the fourth EGFR inhibitor approved by FDA after gefitinib, erlotinib and lapatinib According to relevant statistics, the sales volume of afatini in 2014 was US $115 million, 2015 was US $231 million and 2016 was US $271 million Judging from the sales in 2014-2016, the product maintained a rapid growth rate The market performance of afatini after listing is good, and the global sales volume in 2015 has exceeded that of lapatini According to the data of the drug examination center, alfatinib and tablet of bringer Ingelheim Co., Ltd were approved by CFDA for listing on February 21, 2017, with the trade name of "giterry" The product has been approved for two indications at the same time in China: the first-line treatment for patients with EGFR mutation positive lung cancer, and the second-line treatment for patients with lung squamous cell carcinoma The dosage form is tablet, the specification is 230mg, 40mg, 50mg At present, there are 16 enterprises applying for afatinib in China, including Sinopharm group, Jiangsu Haosen pharmaceutical, Jiangxi Qingfeng pharmaceutical, Qilu pharmaceutical, Yangzijiang pharmaceutical, Jiangsu aosaikang pharmaceutical, Shandong new era pharmaceutical, Ruiyang pharmaceutical, Zhengda Tianqing pharmaceutical, etc The battle for lung cancer targeting drugs in China has been waged for a long time In recent years, gefitinib has reduced its price Exetane and gefitinib have been included in the list of Medicare drugs for the first time More and more lung cancer targeting drugs have entered the Chinese market rapidly, and the drug price has gradually returned to rationality   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans-serif; font-size: 16px; line-height: 25.6px; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); Box sizing: border box! 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Im portant; "> osimtinib will shuffle NSCLC market Osimtinib was developed by AstraZeneca, and was approved by FDA on November 13, 2015 Its trade name is" tagrisso " It is the third generation targeted drug for egrr-t790m mutation positive metastatic non-small cell lung cancer (NSCLC) According to the statistics of relevant data, the sales volume of oshitini in 2015 was US $19 million, and that in 2016 was US $423 million Oshitini has been approved for listing in the United States, the European Union, Japan, Israel, South Korea and Bangladesh, and has shown a strong momentum in the first year of listing According to the prediction of professionals, the peak annual sales of oshitini is expected to reach US $3 billion According to the data retrieved from the drug examination center, AstraZeneca oxitinib and its tablets were approved by CFDA for listing on March 22, 2017, under the trade name of "Teresa", mainly for products with T790M mutation of EGFR in non-small cell lung cancer The dosage form is tablet, the specification is 40mg, 80mg This product is the first third generation lung cancer targeting drug in China According to statistics, about 85% of the 730000 new lung cancer patients in China every year are non-small cell lung cancer, and nearly 50% of them have EGFR T790M mutation Lung cancer is the largest cancer in China, which has a huge clinical demand Patients with T790M mutation after drug resistance such as gefitinib (Iresa), erlotinib (trokai), exetane (Kemena), afatinib (giterib) can use oxitinib In the next few years, the confrontation between the above products will be inevitable According to the public information, in September 2016, oshitini was listed in the fast review channel by CFDA, and was approved seven months later Compared with the approved listing in November 2015 in the United States, the listing time in China is only one year and four months apart NSCLC market is changing The listing of oshitini will usher in the reshuffle of NSCLC market   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans-serif; font-size: 16px; line-height: 25.6px; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); Box sizing: border box! 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Im portant; "> vemurafenib's global market is slightly reduced Vemurafenib was developed by Roche company, and was approved by FDA in August 2011 Its trade name is" zelboraf " It is mainly used for treating melanoma It is the second drug for treating melanoma after the approval of yevoy in the United States The product has been approved in 99 countries and regions including the United States and the European Union Among Roche's global innovative drug pipeline, MEK inhibitor cobimetinib and PD-L1 monoclonal antibody atezolizumab are also targeted at melanoma treatment Different innovative combinations of three drugs are applied to different types of melanoma According to the statistics of relevant data, the sales volume of vimofini in 2015 was US $218 million, and that in 2016 was US $213 million, down 2.2% compared with the same period In terms of sales in 2015-2016, the market of this product has declined In the past two years, the main reason for the decline in sales of veomofeni is the competition between opdivo of Bristol Myers Squibb and keytruda of mosadong In 2016, opdivo and keytruda achieved sales of $3.77 billion and $1.402 billion, respectively According to the data retrieved from the drug examination center, verofinil tablet of Shanghai Roche Pharmaceutical Co., Ltd was approved by CFDA for listing on March 10, 2017, under the trade name of "zobov" It is mainly used to treat unresectable or metastatic melanoma with positive brafv600 mutation determined by CFDA approved test method Verofinil is the first high selective BRAF inhibitor approved on the market in China The dosage form is tablet and the specification is 240mg At present, no domestic enterprise has filed a registration application with CFDA for verofinil tablets Source: medical economics