China's patents for the three heavyweight drugs will expire in 2017. How is the "preparation" progress of local pharmaceutical companies?

According to statistics, in 2017, there are nearly 20 nce (new molecular entity) new drugs whose compound patents are about to expire in China, among which there are 3 heavyweight products with annual sales of more than US $1 billion, respectively: lenalidomide of celgene, tenofovir of Gilead and azanavir of BMS In 2015, the global sales of these three brand drugs exceeded 8.048 billion US dollars, and the treatment field is mainly in anti-tumor and anti infection Among them, celgene's lenalidomide sales reached US $5.801 billion in 2015; BMS's azanavir sales reached US $1.139 billion; Gilead's tenofovir sales reached US $1.108 billion According to the data of domestic sample hospitals, in the first three quarters of 2016, the sales volume of lenalidomide was 10.42 million yuan, and that of tenofovir was 80.02 million yuan Among them, tenofovir is a product with outstanding growth rate in the domestic pharmaceutical market in 2016, which is mainly related to the sharp price reduction of tenofovir Glaxo in 2016 It is estimated that the sales volume of tenofovir's domestic sample hospital is expected to exceed 100 million yuan Rifeme's compound patent in China expires in July 2017 Global: sales are growing rapidly Lenalidomide was developed by celgene company in the United States, with the trade name of "Revlimid" The drug was identified as a rare disease drug by FDA in 2003 and entered the fast approval channel It was approved for the treatment of myelodysplastic syndrome (MDS) in 2005 and multiple myeloma (mm) in 2008 In addition, lenalidomide also has therapeutic effects on a variety of leukemia and solid tumors In June 2013, the FDA approved lenalidomide as a new indication for the treatment of mantle cell lymphoma The indications of lenalidomide are still expanding, and the market space is expected to further expand According to the statistics of the world's best-selling drugs, the sales volume of naduramine reached 5.8 billion US dollars in 2015, an increase of 16.5% over the same period In terms of sales in 2006-2015, the annual compound growth rate of the product is 37.9% In 2014, the global sales of the drug exceeded 5 billion US dollars, and entered the top ten best-selling drugs in the world, ranking 10th in 2015 According to the sales revenue data of the third quarter of 2016, the sales of lenalidomine grew rapidly, and the global sales of the product in 2016 is expected to exceed 6 billion US dollars According to celgene's annual report, the global annual sales of lenalidomide will double again in five years, and the sales will reach 10 billion US dollars by 2020 Domestic: Shuanglu is one step ahead of the rest From the perspective of the market sales of domestic sample hospitals in the past three years, the sales of lenadelamine in 2013 was 1.52 million yuan, the sales in 2014 was 10.68 million yuan, and the sales in 2015 was 13.38 million yuan The market base is small and the growth rate is fast At present, the original research enterprise celgene's lenalidomide is in the stage of market cultivation, and the future market needs to be further explored At present, bortezomib of Janssen and lenalidomide of celgene in the United States are the drugs for the treatment of multiple myeloma in the domestic market At present, both products are under patent protection In the clinical treatment of multiple myeloma in China, bortezomib is mainly used in the first-line treatment, lenalidomide is mainly used in the second-line treatment Lenalidomide was approved to enter China by celgene company of the United States in 2013, with the trade name of "ruifumei" The dosage form is capsule, and the specifications are 5mg, 10mg, 15mg and 25mg Through 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 Many companies have applied for the production of lainaduai capsule, including Beijing Shuanglu pharmaceutical, Jiangsu Haosen pharmaceutical, Zhengda Tianqing pharmaceutical, Qilu pharmaceutical, etc In the short term, Shuanglu pharmaceutical is still at the leading stage of lenalidomide capsule, which has certain advantages compared with the follow-up generic drugs and has been listed in the accelerated application catalog However, the way for other enterprises to put their products on the market is relatively long It is expected that the market competition of lenalidomide will not be too fierce in the future If the product is successfully launched, it will be a major breakthrough for the product line of Shuanglu pharmaceutical industry Relying on low pricing, it is expected to expand the market rapidly and become a potential product to support the company's sustained and high growth Werder's compound patent in China expires in July 2017 Global sales volume exceeds 1 billion US dollars for two consecutive years Tenofovir, developed by Gilead company of the United States, is a new type of nucleotide reverse transcriptase inhibitor It was approved by the U.S FDA in 2001 for the treatment of AIDS In 2008, it was approved by the European Union and the U.S FDA for the treatment of hepatitis B, with the trade name of "Viread" Tenofovir is a star variety of Gilead, which is currently a specific drug for the treatment of AIDS and hepatitis B Tenofovir has some advantages over the main competing drugs, such as adefovir dipivoxil, telbivudine and entecavir According to the statistics of global best-selling drugs, the sales volume of tenofovir reached US $1.108 billion in 2015, an increase of 4.7% over the same period According to the sales situation in 2003-2015, the annual compound growth rate of the product is 5.8% In 2014, the global sales exceeded US $1 billion, 2015 was US $1.108 billion, and has entered the ranks of products with us $1 billion in sales for two consecutive years Domestic: fierce game of imitative enterprises According to the statistics of domestic sample hospitals, the sales volume of tenofovir in 2012 was 2.42 million yuan, the sales volume in 2014 was 9.38 million yuan, the sales volume in 2015 was 25.09 million yuan, an increase of 167% over the same period The sales volume in the first three quarters of 2016 has reached 80.02 million yuan, with a rapid growth The rapid growth of the product is mainly due to the results of the national drug price negotiation on May 20, 2016 The monthly average drug cost of tenofovir dropped from 1500 yuan to 490 yuan, a 67% drop, becoming the lowest price in the world for the treatment of chronic hepatitis B indications, which objectively promoted the market volume of tenofovir in 2016, and will lead to a change in the market of anti hepatitis B drugs Tenofovir was approved to enter China by Gilead company in June 2008 Its trade name is "Werder" Its dosage form is tablet and its specification is 300mg In November 2009, Gilead and GlaxoSmithKline worked together, and GlaxoSmithKline was responsible for the promotion of tenofovir anti hepatitis B drugs in the Chinese market In April 2015, CFDA approved the listing of Werder of GlaxoSmithKline (Tianjin) in China In 2013, tenofovir API from Baker, Anhui Province was approved for production In November 2016, Chengdu Beite Pharmaceutical Co., Ltd obtained CFDA production approval for tenofovir raw materials and tablets, with the tablet specification of 300mg At present, nearly 40 enterprises are applying, including Zhengda Tianqing Pharmaceutical Co., Ltd., Anhui Baker bio Pharmaceutical Co., Ltd., Qilu Pharmaceutical Co., Ltd., Zhuhai United Pharmaceutical Co., Ltd., Shandong Luoxin Pharmaceutical Co., Ltd At present, the domestic enterprises of tenofovir are still in the fierce game Ruiaituo's compound patent in China expires in April 2017 Global: after 2011, the market gradually declined Azanavir was developed by Bristol Myers Squibb Co., Ltd and was approved to be listed in the United States in June 2003 Its trade name is "reyataz", mainly used for the first-line treatment of HIV infection This product is the first protease inhibitor given once a day in the world It is combined with other antiviral drugs for the antiviral treatment of AIDS It has the characteristics of continuous strong inhibition of HIV, low drug resistance, convenient use of drugs, and small side effects on fat metabolism According to the statistics of global best-selling drugs, the sales volume of azanavir in 2005 was US $596 million, the sales volume reached a peak of US $1569 million in 2011 and US $1139 million in 2015, down 16.4% compared with the same period According to the sales situation in 2003-2015, the annual compound growth rate of the product is 5.8% In 2007, the global sales of azanavir exceeded 1 billion US dollars, peaked in 2011, and the market gradually declined after 2011 Domestic: there is no sales data in the sample hospital Currently, azanavir, a Bristol Myers Squibb Company, has been approved to be listed in China The product name is "ruieto", the dosage form is capsule, and the specifications are 0.1g, 0.15g and 0.2g The product has no sales data in the sample hospital In China, anti HIV drugs are produced and purchased at designated points, incorporated into the national drug reserve, distributed and allocated in a unified way, and distributed level by level through the national disease prevention and control network Therefore, the market of azanavir is not reflected in the domestic sample hospitals.