Global sales total 21.8 billion US dollars! 26 key imported drugs approved in 2017 to restructure the domestic market

Source: in 2018-02-28, 2017, CFDA issued a total of 375 drug approval numbers, excluding medical oxygen, basic infusion and other approvals, with a total of 303 approvals and 163 drugs Chemical medicine accounted for 94.4%, biological products and traditional Chinese medicine accounted for 5.6% Domestic drugs accounted for 59.4%, imported drugs accounted for 40.6%, and the number of approval documents for domestic and imported drugs was close With the implementation of a series of new drug review policies and priority review systems in China, the speed of approval of imported drugs has been significantly accelerated These imported new drugs mainly include: hepatitis C, tumor, diabetes, Parkinson's disease, AIDS, hypertension, depression, etc Now, 26 key imported products in 2017 are sorted out According to statistics, the global sales of these 26 drugs in 2016 reached 21.8 billion US dollars, including 6 hepatitis C drugs sales of 7.207 billion US dollars, 8 tumor drugs sales of 6.95 billion US dollars, 6 diabetes drugs sales of 4.406 billion US dollars, and 4 other indication drugs sales of 3249 million US dollars In 2017, more than 20 imported new drugs from foreign enterprises were listed in China, including bringer Ingelheim, Novartis, AstraZeneca, Aberdeen, Bristol Myers Squibb, Gilead, Johnson & Johnson, Bayer, Roche, MSD, Novo Nordisk, Sanofi, etc Among them, Boehringer Ingelheim and Novartis were approved to import the most products After a large number of new imported drugs are approved, many imported products flow into the Chinese market, and the pattern of domestic drug market is expected to be reconstructed Antineoplastic drugs are in the field of tumor treatment The key products approved for marketing in 2017 are: pezopanil tablets, alfatinib maleate, verofinib tablets, lucotinib phosphate tablets, regofinib tablets, oxitinib mesylate tablets, azacitidine for injection, ibotinib capsule In 2016, the global sales of these eight products reached US $6.95 billion Variety of pezopanil tablets: in February 2017, pezopanil tablets, a renal cell cancer treatment drug of GlaxoSmithKline, was approved for import, with the trade name of "weiquante" and specifications of 200mg and 400mg In 2016, the global sales of pezopanil was $729 million Alfatinib maleate tablets: in February 2017, alfatinib maleate tablets, a lung cancer treatment drug of Boehringer Ingelheim, was approved for import, with the trade name of "giterry" and specifications of 20mg, 30mg, 40mg and 50mg Afatini's global sales in 2016 were $271 million Verofinil tablets: in February 2017, verofinil tablets, a Roche melanoma treatment drug, was approved for import, with the trade name of "zobofu" and the specification of 240mg In 2016, vimofini's global sales volume was US $220 million Lucotinib phosphate tablets: in March 2017, Novartis' lucotinib phosphate tablets for leukemia treatment were approved for import, with the trade name of "jiekewei", and the specifications of 5mg, 15mg and 20mg In 2016, the global sales of lucotinib was $1434 million Regofinib phosphate tablets: in March 2017, the Bayer gastrointestinal stromal tumor treatment drug regofinib phosphate tablets were approved for import, the trade name is "baivango", the specification is 40mg In 2016, regofini's global sales were $304 million Oxitinib mesylate tablets: in March 2017, oxitinib mesylate tablets, the AstraZeneca lung cancer treatment drug, was approved for import, the trade name is "Teresa", the dosage form is tablet, the specification is 40mg, 80mg In 2016, oshitini's global sales were $423 million Azacytidine for injection: in April 2017, azacytidine for injection, a leukemic treatment drug of Xinji company, was approved for import, with the trade name of "weidazhi" and the dosage form of powder injection, with the specification of 100mg In 2016, the global sales volume of the drug was $738 million Ibudinib capsule: in August 2017, ibudinib capsule, a leukemia treatment drug of ibudinib company, was approved for import with the trade name of "Yike" and the specification of 140mg In 2016, ibtini's global sales were $2.831 billion It is commented that the main anti-tumor drugs approved for import in 2017 are targeted drugs, including two lung cancer products, namely, afatinib and oxitinib; three leukemia products, namely, lucotinib phosphate, azacytidine for injection and ibotinib capsule Among the above products, ibotinib and lucotinib are the heavyweight products with global sales of more than US $1 billion in 2016 It is expected that the market competition for lung cancer and leukemia drugs will be further intensified in 2018 In the field of diabetes treatment, the heavyweight products approved for marketing in 2017 are: daggliptin tablets, liggliptin metformin tablets, liggliptin tablets, engegliptin tablets, degu insulin injection, caggliptin tablets, lisnertide injection In 2016, the global sales of the above products reached USD 4.406 billion Variety: in March 2017, AstraZeneca dagreen tablets were approved for import with the trade name of "andatang" and the specifications of 5mg and 10mg In 2016, daglie's net global sales were US $907 million Shagliptin metformin sustained-release tablets: in September 2017, shagliptin metformin sustained-release tablets of bolingyingehan company were approved for import, with the trade name of "orbinine" and the specifications of 2.5mg/500mg and 2.5mg/850mg In 2016, the global sales volume of sagletin metformin was US $1249 million Gligliptin tablets: in September 2017, glingham gliptin tablets were approved for import, with the trade name of "otannin" and the specification of 5mg In 2016, ligletin's global sales volume was US $1.685 billion Englishnet tablets: in September 2017, the imported products were approved, with the trade name of "Ou Tangjing" and the specifications of 10mg and 25mg In 2016, the company's net global sales were US $202 million Degu insulin injection: in September 2017, Novo nordegu insulin injection was approved for import with the trade name of "novo Heda" and the specification of 3ml: 300 units In 2016, global sales of degu insulin reached US $603 million Kagliptin tablets: in September 2017, Johnson kagliptin tablets were approved for import with the trade name of "yike'an" and the specifications of 100mg and 300mg In 2016, caglie's net global sales were $1.407 billion Lisinotide injection: in September 2017, sanofilisinotide injection was approved for import under the trade name of "yikean", with the specification of 10 μ g dose pen and 20 μ g dose pen In 2016, lisnertide's global sales volume was US $39 million In the field of diabetes treatment, in 2017, China approved the import of three sglt-2 inhibitor drugs, namely, daggliptin, caggliptin, and engegliptin; DPP-4 inhibitor compound preparation of gliptin metformin tablets, saggliptin metformin sustained-release tablets; GLP-1 glucagon like peptide receptor agonist of lisinotide injection The launch of these new products means that DPP-4, GLP-1 and sglt-2 diabetes drugs have been rapidly introduced into China The influx of new target diabetes drugs into the market will certainly stir up the domestic market pattern In the field of hepatitis C treatment, the heavyweight products approved for marketing in 2017 are: ashurevir soft capsule, dalatavir hydrochloride tablet, simiravei capsule, sophibuvir tablet, obipali tablet, and dasebovir sodium tablet In 2016, the global sales volume of the above products was $7.207 billion Varieties of ashurevir soft capsule and dalatawei tablet: in April 2017, Bristol Myers Squibb ashurevir soft capsule and dalatawei tablet were approved for import, with the trade names of "swipe" and "Blitzer" respectively In 2016, global sales of ashuribe and dalatawei totaled USD 1.578 billion Cimerevir capsule: in August 2017, Johnson cimerevir capsule was approved for import with the trade name of "oreson" and the specification of 150mg In 2016, cimereway's global sales volume was US $106 million Suophobuvir tablets: in September 2017, Gilead suophobuvir tablets were approved for import with the trade name of "suuodi" and the specification of 400mg In 2016, the global sales volume of sophopbuvir was US $401 million, and in 2014, the global sales volume of the drug exceeded US $10 billion Obipali tablets and dasebway sodium tablets: in September 2017, ibreviobipali tablets and dasebway sodium tablets were approved for import, with the trade names of "weijianle" and "yichery" respectively, with specifications of 12.5mg/75mg/50mg and 250mg In 2016, the total global sales of obipali and dasebwe were USD 1522 million Comments in the field of hepatitis C treatment, in 2017 CFDA successively approved the listing of six new anti hepatitis drugs, ashuribe, dalatawei, simiravei, dasebweir, obipali and sophibuvir At present, the new oral hepatitis C drugs of Bristol Myers Squibb, Johnson & Johnson, Gilead and Aberdeen have been on the market in China After the rapid outbreak and contraction of the hepatitis C market in the United States, the battle of new hepatitis C drugs, which has been proved to be effective in Europe and the United States, will be officially staged in China, which indicates that the domestic hepatitis C treatment market will change dramatically Other indications in terms of other indications, the heavyweight products approved for marketing in 2017 are: tetravalent human papillomavirus vaccine, omazumab for injection, sacubatrevalsartan sodium tablet and nidanib soft capsule In 2016, the global sales of the above four products were US $3249 million Tetravalent human papillomavirus vaccine: in May 2017, the cervical cancer vaccine tetravalent human papillomavirus vaccine of MSD company was approved for import, the trade name is "jiadaxiu", the dosage form is injection, the specification is 0.5ml In 2009, the global sales of HPV vaccine reached US $1.661 billion Omazumab for injection: in August 2017, the omazumab for injection for Novartis in the treatment of COPD was approved for import, with the trade name of "Zhuo le" and the dosage form of powder injection, with the specification of 150mg In 2016, the global sales of omazumab reached US $2356 million Sacubatrovalsartan sodium tablets: in September 2017, Novartis new drug for the treatment of heart failure, sacubatrovalsartan sodium tablets, was approved for import, with the trade name of "Novartis" and the specifications of 50mg, 100mg and 200mg In 2016, the global sales volume of valsartan in sakuba was US $170 million Nedanib ethylsulfonate soft capsule: in September 2017, the new lung fibrosis drug, nedanib ethylsulfonate soft capsule, was approved for import, the trade name is "vegat", the specification is 100mg, 150mg In 2016, the global sales volume of nedanib was $723 million Conclusion: in 2017, with the opening of the registration policy of imported drugs, the inclination of imported new drugs increased, the speed of review and approval accelerated significantly, and the large-scale listing of imported new drugs has formed a new wave of imported drugs.