25 innovative drugs were approved in the first half of the year! Six major domestic pharmaceutical companies including Hausen and Fosun "preemptive strikes"

Pharmaceutical Network July 7th, the first half of this year under the pressure of the new crown virus epidemic, the U.SFDA in the approval of innovative drugs show beautiful report card, has approved 25 innovative drugs, including 20 new molecular entities and 5 biological drugs, involving a variety of treatment areas, special approval channels "multi-pronged", antibody drug status, Chinese pharmaceutical companies for new drugs to enter the Chinese market to actively pave the wayTable 1: Fda approved new drug informationof innovative drugs, iron-hit anti-tumor drugsthe first half of the approved 25 new drugs, distributed in anti-tumor and immunomodulators, nervous system drugs, digestive system and metabolic drugs, cardiovascular drugs, sensory system drugs and antiparasitic drugs, insecticides and insect repellents and other 7 therapeutic areas, ranked first in the anti-tumor and immunomodulators, accounting for 44% of the total number of new drugs approvedFigure 1: In the first half of the year, the global cancer incidence and mortality rate has continued to risethe global cancer incidence and mortality rate has continued to rise, the world anti-tumor drug market is growing rapidly, according to Evaluate Pharma data, the global cancer drug market is expected to exceed 150 billion U.Sdollars by 2020The huge market space, so that the anti-tumor market has become the focus of competition among pharmaceutical giantsIn the first half of 2020, the heat of anti-tumor drugs is still high, the FDA approved a total of 11 new anti-tumor drugs, involving gastrointestinal interstitial memanoma, sanybreast breast cancer, non-small cell lung cancer, bile duct cancer and other tumorsIt's worth noting that in the last two years, the world's hot antibody conjugate drug (ADC) has made a new breakthrough, and in April the FDA approved the world's fourth ADC drug, Trodelvy (sacituzumab govitecan-hziy), to treat triple-negative breast cancer patientsWith the advent of the genetic age, the cancer mechanism to obtain a deeper understanding, the same tumor species can be continuously refined classification, anti-tumor drug indications will be more and more fine scope, research and development drug companies are more inclined to first choose a rare disease definition of the adaptation of the market, the use of "orphan medicine" policy dividends quickly occupy the market space, and then expand the scope of indications, K drug 2014 through melanoma indications market and then all the way to expand the adaptation map is a good exampleIn the first half of 2020, 10 of the 11 anti-tumor drugs approved for sale were certified as orphan drugs, accounting for more than 90%, which fully demonstrates the importance of this strategy in the field of anti-tumorThe "multi-pronged" special approval channel promotes innovation
without compromising the safety and efficacy of drugsstandards , and in order to facilitate the rapid roll-out of drugs of significant therapeutic value, the FDA has set up four special approval channels, namely Breakthrough Therapeutics, Priority Review, Fast Track, and Accelerated Approval Simply put, the drugs in the above four special channels can be guided by FDA expertintervention at different degrees and stages, accelerate the development process, or shorten the review cycle during the review phase and get an FDA response as soon as possible 　　In the first half of 2020, the FDA used a "multi-pronged" special approval channel to enhance the speed and efficiency of innovative drug development and approval Of the innovative drugs approved in the first half of the year, 40 per cent were identified as breakthrough therapies, 40 per cent were eligible for priority review, 16 per cent were eligible for fast-track and 28 per cent were approved at an accelerated rate Overall, 11 innovative drugs (56%) were at least one of the FDA's four qualifications 　　Table 2: 25 special approval channels for new drugs summarize antibodies, biologic drug market well-deserved "middle-stream column" in recent years, the rapid development of the biological drug market, has become an integral part of the global pharmaceutical market According to the 2019 results released by the world's major pharmaceutical giants, six of the world's top 10 best-selling drugs in 2019 were biologicdrugs with a combined sales of about $61.57 billion, accounting for 62.8 percent of the top 10 drugs, once again validating global market acceptance of biologic drugs 　　Biopharmaceutical market can be subdivided into antibodies, fusion protein, EPO, G-CSF, follicle-promoting hormones and other specific areas, among them, antibody drugs by virtue of strong specificity, small side effects and other advantages, coupled with the continuous promotion of clinical research and commercialization strategy, antibody drugs are becoming more mature in all aspects, market capacity is rapidly rising, has become the most important varieties of biological drugs, when the biological drug market "middle-stream column." 　　Since 2014, new antibody drug approvals have increased explosively, with 52 new antibody drugs approved in the six years from 2014 to 2019 In the first half of 2020, the FDA approved a total of five biologic drugs, all of which were contracted by antibody drugs, including four monotomaabs (teprotumumab, eptinezumab, isatuximab, inebilizumab), and one ADC drug (sacituzumab govitecan), which showed that antibody drugs have become aces in the field of biopharmaceuticaldrugs and are among the major drug giants 　　Figure 2: FDA approved new drugs and antibody new drugs actively introduce innovative drugs, domestic pharmaceutical enterprises to innovation transformation
in recent years, China's pharmaceutical innovation environment continues to improve, a series of regulatory policies to encourage drug innovation, innovative drugs into the health insurance catalog of the path accelerated widening, all kinds of government funds, a large amount of social capital into the pharmaceutical innovation field At the same time, under the policy of consistency evaluation, procurement , generic drugs are facing increasing price reduction pressure, in this context, more enterprises to find a way out of pharmaceutical innovation Among them, through the introduction of global innovative drugs rapid layout of the domestic market, has become a domestic pharmaceutical enterprises to innovation transformation into a major weapon 　　In the first half of 2020, six of the 25 innovative drugs approved by the FDA have been introduced into the Chinese market by domestic pharmaceutical companies, with Cinda Bio, Haussen, Reding Pharmaceuticals, Green Leaf Pharmaceuticals, Keystone Pharmaceuticals and Fosun having rights to develop and commercialize in China, respectively, pemigatinib, inebilizumab, ripretinib, lunecnitedin, avaprinib, opicapone Table 3:6 domestic progress in the introduction of new drugs 　　They introduced these new drugs to the domestic Avapritinib: developed by Blueprint Pharmaceuticals and approved by the FDA in January 2020 for the treatment of patients with platelet-derived growth factor receptor alpha (PDGFRA) gene exon 18 mutations (including PDGFRA D842V mutations) of non-removable or metastatic gastrointestinal interstontic menoma (GIST) This is the world's first approved precision therapy for the treatment of GIST patient groups For patients with non-removable or metastatic GIST patients with PDGFRA exon 18 mutations (including PDGFRA D842V mutations), resistant to conventional drugs such as rigofenib, are no longer viable, and Avapritinib is expected to provide a new treatment option for these patients In June 2018, Keystone Pharmaceuticals and Blueprint Pharmaceuticals reached an exclusive cooperation and licensing agreement to promote the development and commercialization of single or combination therapy for three drugs, including avapritinib, in Chinese mainland and in Hong Kong, Macau and Taiwan 　　Pemigatinib: In April 2020, Incyte's target inge Pemigatinib was approved in the U.S for the treatment of adults with FGFR2 gene fusion or other resectionandable, non-surgically removable, local advanced or metastatic bile duct cancer who have previously been treated with FDA-approved methods Pemazyre is the first targeted drug approved for the treatment of bile duct cancer At the end of 2018, Cinda Bio and Incyte reached a strategic partnership on three clinical phase candidates for Incyte's pemigatinib, itacitinib and parsaclisib, and Cinda Bio has the rights to develop and commercialize the three drugs in China (including Hong Kong/Macau, Taiwan) 　　Opicapone: Onicapys also received FDA approval in April 2020 as a levodopa/kabidoba-assisted treatment for patients with Parkinson's disease who have experienced a "shutdown" period Ongentys is the first FDA-approved CATanophenol oxygen-level methyl transferase (COMT) inhibitor to reduce the "OFF" period and not cause movement disorders The drug was first developed by BIAL Pharmaceuticals, and in January 2018, Fosun Pharma obtained exclusive rights to the Chinese market from BIAL for $18 million 　　Inebilizumab: In June 2020, AstraZeneca subsidiary Viela Bio Pharmaceuticals approved the U.S market for the use of anti-water channel protein-4 (AQP4) antibody-positive patients with nMOSD Uplizna is the second innovative treatment approved worldwide for the treatment of AQP4 antibody-positive NMOSD patients Prior to that month, Howson Pharmaceuticals entered into a strategic partnership with Viela Bio, which has the right to develop and commercialize Inebilizumab for NMOSD and other potential inflammatory/autoimmune and hematologic malignancy indications in China 　　Ripretinib: In May 2020, Qinlock of Deciphera Pharmaceuticals received FDA approval for four-line treatment for advanced gastrointestinal interstitial oma (GIST) The drug is the first FDA-approved target drug for four-line treatment of gastrointestinal methoma Qinlock is intended for adult patients who have previously been treated with three or more kinase inhibitors, including Imartini, Shoneib, and Rigofini In June 2019, Reding Pharmaceuticals entered into an exclusive licensing agreement with Deciphera Pharmaceuticals to advance the development and commercialization of Ripretinib in Greater China (Chinese mainland, Hong Kong, Macau and Taiwan) 　　Lurbinectedin: In June 2020, PharmaMar, in collaboration with Jazz Pharmaceuticals, obtained FDA approval for second-line treatment for patients with metastatic small cell lung cancer (SCLC) who received chemotherapy for platinum-containing drugs or later In April 2019, Greenleaf Pharmaceuticals and PharmaMar entered into an authorized research and development cooperation agreement to obtain exclusive rights to the development and commercialization of lurbinectedin in China, including small cell lung cancer, all indications, and can require PharmaMar to carry out the technical transfer of the drug, produced by Greenleaf Pharmaceuticals in China Source: FDA Website, Corporate Bulletin, MoneNet Database
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