The first generic drug that broke through successfully in 2017

Source: pharmaceutical economic news January 18, 2018 a series of policies have been issued by the state in recent years, including encouraging drug innovation, priority review, drug listing permit holder system, generic drug consistency evaluation, etc., which are of great significance to regulate the order of drug production and circulation and guide the healthy development of China's pharmaceutical industry The first generic product has always been the focus of research and development layout of many domestic pharmaceutical enterprises With the reform of national new drug review and approval, especially the formal implementation of the priority review system, the approval speed of the first generic product is accelerating day by day   In 2017, the first imitated products that have been approved for marketing mainly include: kapofungin acetate for injection of Hengrui, tenofovir dipivoxil fumarate capsule of guangshengtang, lenalidomide capsule of Shuanglu, bortezomib for injection of hausen, parecoxib sodium for injection of Kelun, modafinil capsule of Wellman in North Hunan, latantieme eye drops of Qilu pharmaceutical, injection weight of Shanghai United sail Group B: tripeptide, etc With advanced technology, the first imitation products can cultivate new markets, with considerable profits and relatively low difficulty of product innovation, which can bring good performance to enterprises In the future, the situation of import substitution in the field of high-end products will be increasingly intensified Kapofungin [the original research enterprise] MSD [the first imitation in China] Hengrui [comments] broke an independent situation Hengrui dominated the domestic market, and kapofungin was researched and developed by MSD company, and was approved to be listed by FDA in January 2001, with the commodity name of "Cancidas" Kapofungin is a new echinocandin antifungal drug, which is mainly used in the treatment of invasive Aspergillus that can not tolerate other antifungal drugs The dosage form is powder injection, the specifications are 50mg and 70mg Kapofungin was approved to be imported and listed in China in 2005, with the commodity name of "Kosis" In January 2017, kapofungin acetate for injection of Hengrui was listed on the market for the first time in China, which was the first imitated variety approved by Hengrui through priority review At present, MSD is still dominant in the domestic kapofen net market, and Hengrui has sales share in some regions The listing of domestic products has broken the unique situation of moshadong, which will have a great impact on the share of original research drugs in the future, and the domestic market will be gradually occupied by Hengrui in the future In addition, many domestic enterprises are very optimistic about the market of echinocandin antifungal drugs, and are stepping up the layout According to the statistics of global best-selling drug data, in 2003, the net sales volume of capofin was US $276 million, in 2014, the sales volume reached US $681 million, in 2015, the sales volume was US $573 million, and in 2016, the sales volume was US $558 million In 2003-2016, the global market of carpofyn grew rapidly, while in 2015-2016, it slowed down steadily According to the data of domestic sample hospitals, the growth trend of kapofen in 2012-2016 was rapid The sales volume in 2012 was 260 million yuan, that in 2015 was 410 million yuan, and that in 2016 was 450 million yuan, with a compound growth rate of 15.1% in 2012-2016 Carpofungin has been on the market since its excellent efficacy, rapid market volume Lenalidomide [original research enterprise] Xinji [domestic first imitation] Shuanglu [comment] domestic lenalidomide was approved at the end of eight years In the future market, lenalidomide will be developed by celgene company in the United States, with the commodity name of "revilid" The drug was approved by FDA in 2005 for myelodysplastic syndrome (MDS), and then in 2008 for multiple myeloma (mm) In June 2013, the FDA approved lenalidomide as a new indication for the treatment of mantle cell lymphoma Lenalidomide was approved to be imported and listed in China in 2013 Its trade name is "ruifumei" Its dosage form is capsule, with specifications of 5mg, 10mg, 15mg and 25mg At present, rifeme has two indications approved in China, i.e multiple myeloma and myelodysplastic syndrome The patent expires in 2024 In 2017, rifeme entered the national medical insurance catalog through drug price negotiation In November 2017, Shuanglu lenalidomide capsule was first imitated and marketed in China, and domestic lenalidomide capsule was finally approved after 8 years After searching the CFDA database, there are more than ten enterprises applying for lenalidomide capsules and tablets in China, and the main dosage forms are lenalidomide capsules and Benadryl sulfonate lenalidomide tablets The enterprise applying for the tablets is Tianjin Michelle Technology Development Co., Ltd Lenalidomide capsule has been applied for production by more than ten companies including Qilu pharmaceutical, hausen pharmaceutical and Zhengda Tianqing According to the statistics of global best-selling drugs, the sales volume of naduramine in 2006 was US $361 million, 2015 was US $5.801 billion and 2016 was US $6.974 billion From 2006 to 2016, Nadu amine Market showed a rapid growth trend According to the data of domestic sample hospitals, the sales volume of lenalidomide was 1.75 million yuan in 2013, 10.78 million yuan in 2014 and 19.62 million yuan in 2016 The market base is small and the growth rate is fast At present, the original research products have only been listed in China for 4 years, and the future market needs to be further explored Bortezomii [the original research enterprise] Xi'an YANGSEN [the first imitation in China] hausen [comments] has seen high sales More than 20 enterprises have stepped up the layout Bortezomii was developed by Janssen company, a subsidiary of Johnson & Johnson in the United States, with the commodity name of "Velcade" Bortezomib has different therapeutic effects on multiple myeloma, mantle cell lymphoma and other tumors in blood tumors, and it has been listed in more than 80 countries Bortezomib of Janssen was approved to enter the domestic market in September 2005 Its trade name is "Wanke" Its dosage form is powder injection, with specifications of 1.0mg and 3.5mg In March 2016, Jiangsu Haosen bortezomib and its preparation were listed in the priority review for the reason that the original research drug has expired or is about to expire, and they are the enterprises with the fastest application progress In November 2017, hausen bortezomib was first imitated and marketed in China, mainly for the treatment of multiple myeloma and mantle cell lymphoma Yang Sen's bortezomib has entered the medical insurance catalogue through the drug price negotiation in 2017 As the Chinese patent protection of bortezomib has expired, domestic application is extremely hot After searching the CFDA database, there are more than 20 enterprises applying for bortezomib in China, including Qilu pharmaceutical, Zhengda Tianqing, Haizheng pharmaceutical, aosaikang, etc According to the statistics of global best-selling drug data, the sales volume of bortezomib in 2004 was US $143 million, the sales volume in 2015 was US $2647 million, and the sales volume in 2016 was US $2.503 billion, down 5.4% compared with the same period In 2009-2016, the compound annual growth rate of the drug was 20.2% According to the data of domestic sample hospitals, the sales of bortezomib increased rapidly from 2012 to 2016 The sales volume was 50.14 million yuan in 2012, 190 million yuan in 2014, 210 million yuan in 2015 and 223 million yuan in 2016 In 2016, bortezomib became the largest product in Xi'an Janssen's domestic market Palexib [original research enterprise] Pfizer [domestic first imitation] Kelen [comment] sales growth is fast, domestic generic drugs rapidly layout by virtue of price advantage Palexib is jointly developed by Pfizer and famasia company, the commodity name is "dynastat", mainly used for short-term treatment of postoperative pain The dosage form is powder injection, the specifications are 20mg and 40mg Parecoxib sodium for injection was first listed in Europe in 2002, and now it has been listed in at least 15 countries such as Germany, France and the United Kingdom In April 2017, the patent expired In May 2008, Pfizer's parecoxib sodium for injection was listed on the market in China, with the trade name of "Tenax" In 2017, it was listed in category B of national medical insurance In November 2017, Coren company approved the listing of parecoxib sodium for injection in China At present, there are more than 20 enterprises applying for the preparation of parixib sodium for injection in China The key enterprises include Jiangsu Hengrui, Qilu pharmaceutical, Jiangsu aosaikang, Zhengda Tianqing, and Ouyi pharmaceutical of Petrochemicals Group The product has a broad market space With the price advantage of generic drugs, Kelun will accelerate the expansion of market share and realize import substitution According to the data of domestic sample hospitals, from 2012 to 2016, parecoxib showed a rapid growth trend In 2012, the amount of drugs used was 170 million yuan, in 2014, 230 million yuan, in 2015, 240 million yuan, and in 2016, 280 million yuan, an increase of 15.5% over the same period Tripatide [original research enterprise] Lilly [first imitation in China] Shanghai United cell biology [review] the first approved biological product in 2017, with a promising market prospect Tripatide is the original research product of Lilly company It was approved by FDA in the United States on November 26, 2002, EMA in Europe on June 10, 2003, and PMDA in Japan on July 23, 2010 Its trade name is Forteo and forsteo The product was first approved for use in postmenopausal women with osteoporosis, early stage or hypogonadism Later, new indications were added for the treatment of osteoporosis related to persistent, systemic glucocorticoid treatment with high risk of fracture In March 2011, Lilly's tripatide was listed in China, with the trade name of "forteol" and the dosage form of injection In March 2017, the first domestic bioprosthetic like drug, which was jointly developed by cel, was approved for marketing, with the trade name of "zhengu" As the first biological product approved for market in 2017, the drug will provide a new choice for domestic osteoporosis patients According to the statistics of global best-selling drug data, the sales volume of tripeptide in 2005 was 389 million US dollars, the sales volume in 2015 was up to 16001 million US dollars, and the sales volume in 2016 was 1.72 billion US dollars The market growth rate from 2005 to 2016 was fast The clinical effect of the drug is outstanding Many patients' symptoms of bone pain and quality of life have been greatly improved For those patients with severe osteoporosis and fracture, it can significantly relieve the body pain and restore the ability of self-care of the elderly patients According to the data of 22 sample hospitals in China, in 2012, the sales volume of tripatide was 850000 yuan, in 2015, 8.2 million yuan, and in 2016, 12.37 million yuan, up 50.8% year on year Judging from the domestic market situation, the market sales base of the product is relatively low due to its late listing Since 2014, the market share of tripeptide has continued to increase.