The biggest winner of innovative drugs approved in 2019: Novartis
Last Update: 2020-06-19
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As of December 28, the U.SFDA approved 48 new drugs (including new molecular entities and new biological products), slightly lower than the 59 in 2018; the EU EMA approved 37 new drugs (including new active substances, excluding generic drugs and biological analogues), lower than the 64 in 2018; China nmpa approved 48 NEW drugs (including chemical drugs 1 and 5.1, Category 1 and 2 of biological products, traditional Chinese medicine and vaccines), slightly lower than the 53 in 2018< br / > in this paper, the approval of each regulatory agency is counted separately, and 20 enterprises with the largest number of new drugs approved in 2019 are counted from the enterprise dimensionThe results show that Novartis is the biggest winner in the approval of innovative drugs in 2019, with a total of 10 approvalsGSK, Pfizer and Johnson & Johnson were the next three drugs approvedLilly, aberway and AstraZeneca each have four items, the first three in total, Bayer and Weicai each have three itemsThe number of new drugs approved by these 10 enterprises in the regulatory market in Europe, America and China in 2019 ranks top 10 in the list< br / > enterprises with the largest number of approved innovative drugs in 2019 < br / > No.1 Novartis < br / > Novartis only received one new drug from FDA in 2018, and this year saw a great harvestSix new drugs were picked from FDA, ranking first on the FDA approval listIncluding: egaten (triclabendazole) in the treatment of 6-year-old patients with clonorchiasis, < br / > mayzent (siponimod) in the treatment of adult multiple sclerosis, < br / > piqray (Alpine) in the treatment of HR +, HER2 - PI3K α mutation in postmenopausal women with breast cancer after endocrine therapy in combination with fluvectin;Zolgensma (onasemnogene abeparvovac-xioi), a gene therapy product for patients under 2 years of age with spinal muscular atrophy (SMA) carrying mutations in two SMN1 alleles encoding motor neuron survival protein (SMN);Beovu (brolucizumab), a monoclonal antibody against wet age-related macular degeneration; < br / > adakveo (crizanlizumab TMCA), a monoclonal antibody used to reduce the frequency of vascular occlusion crisis in patients over 16 years old with sickle cell anemia, was approved by Novartis in 2019 < br / > source: the magic formula of medicine < br / > in addition to ranking first in the FDA, Novartis in 2019 was also the first in ChinaIt includes the treatment of psoriatic IL-17A monoclonal antibody drug, scuchiumab injection, the treatment of multiple sclerosis with fengomod hydrochloride capsule, and the treatment of BRAF V600 mutation positive non resectable or metastatic melanoma with dafetinib mesylate capsule and trimetinib tablets< br / > in fact, Novartis has not only gained the most new varieties in China in 2019, but also the biggest winner in the medical insurance negotiationSeven varieties, such as sakubatravsartan sodium tablets, omazumab for injection, and rapuzumab injection, have entered the national medical insurance through negotiation, Four drugs, i.eetrapa ethanolamine tablets, risperidone transdermal patch, metformin and viagliptin tablets, and 0.5% moxifloxacin hydrochloride eye drops, entered the medical insurance catalogue through routine access< br / > Dr John Tsai, head of global drug development and chief medical officer of Novartis, also said in public that in view of nmpa's accelerated review and approval of new drugs, Novartis plans to submit 50 new drug applications (NDAs) in China by 2023 < br / > at "R & D day of Novartis" on December 5, Dr Jay Bradner, President of Novartis biomedical research center (NIBR), said that NIBR is an important internal R & D engine of Novartis, with about 5600 scientists, 340 development projects and more than 90 new molecular entities (NME) under research One of the research and development focuses of NIBR is to develop a new generation of treatment model technology platform, which includes cell therapy, gene therapy, molecular glues, radioligand therapy and other emerging technology platforms < br / > previously, the evaluation Pharma report predicted that Novartis would surpass Pfizer and Roche in 2024, and become the world's largest prescription drug company with a revenue of 53.2 billion US dollars According to the pace of new drug application and approval, Novartis will soon return to the top of the industry (see: in 2024, Novartis will become the world's largest pharmaceutical company?) < br / > No.2 GSK < br / > in 2019, GSK did not harvest new products from FDA of the United States, but EMA of Europe and nmpa of China respectively approved the listing of three new drugs < br / > GlaxoSmithKline was approved as a new drug in 2019 < br / > source: medicine magic cube < br / > GSK's current advantages focus on respiratory disease, AIDS and vaccines Unfortunately, in a complete reply letter, FDA recently refused to approve cabenuva (CAB / RPV), a long-acting HIV group injection developed by Viiv healthcare, a holding company of GSK, because of the "CMC related" issue < br / > No.3 Pfizer < br / > Pfizer obtained 4 new drugs from FDA in 2018, but only 1 in 2019 The good news is that EMA and nmpa have brought good news for it, making it up to six new drugs approved annually < br / > Pfizer was approved as a new drug in 2019 < br / > source: medicine magic cube < br / > No.4 Johnson & Johnson < br / > in April this year, FDA approved balversa (erdafitinib), a subsidiary of Johnson & Johnson, to treat adult patients with locally advanced or metastatic bladder cancer Balversa has been awarded the breakthrough treatment certification, and a companion diagnostic device developed by Qiagen has been approved to detect mutations in FGFR2 and FGFR3 The device will be used to select patients with FGFR2 and FGFR3 mutations for balversa treatment < br / > Johnson & Johnson was approved as a new drug in 2019 < br / > source: medicine magic cube < br / > in addition, Johnson & Johnson has also taken off two new drug marketing rights in the EU: erlada (aplutamide) for the treatment of adult male non metastatic castration resistance to prostate cancer and spravato (esketamine) for the treatment of severe depression The three new drugs approved by Johnson & Johnson in China are the multiple myeloma drug Zhaoke (daretozumab injection), castration resistant prostate cancer ansenke (apatamide tablets), and tenoya (gusecyiumab injection) for the treatment of moderate and severe plaque psoriasis Among them, daretozumab is the first anti-CD38 monoclonal antibody in the world, and gussechiumab has been listed in the first batch of new drugs urgently needed abroad < br / > No.5 abwi < br / > in June this year, abwi and Erjian announced that they have signed a final transaction agreement, under which abwi will purchase eljian in the form of cash and stock transactions, with a transaction amount of up to US $63 billion < br / > EBV was approved in 2019 < br / > source: drug magic cube < br / > EBV took two new drugs from FDA in 2019, namely skyrizi (risankizumab rzaa) for plaque psoriasis and rinvoq (upadacitinib) for moderate and severe rheumatoid arthritis patients who were not responsive or tolerant to MTX Among them, skyrizi (risankizumab rzaa) was also approved by EMA two days after FDA approval Aibowei's DAA drug for hepatitis C infection with gene 1-6, enoxavir (gremivir tablets), was approved for marketing by China's nmpa in May this year < br / > on December 23, Erjian announced that FDA approved the listing application of ubrogepant for acute treatment of adult migraine patients, which is also the first oral small molecule calcitonin gene-related peptide (CGRP) receptor antagonist approved by FDA The new drug is not under the name of Aberdeen because the deal between Aberdeen and Elgin has not yet been settled < br / > No.6 Lilly < br / > is different from other multinational pharmaceutical companies in the arrangement of tumor drugs Lilly has chosen to work in the fields of diabetes, autoimmune diseases and migraine In 2019, Lilly has 3 new drugs approved in China, which is second only to Novartis, the same as GSK and AstraZeneca < br / > Lilly was approved as a new drug in 2019 < br / > source: drug magic cube < br / > in October this year, FDA approved the launch of Lilly migraine drug reyvow (lasmiditan), which was first developed by Lilly, authorized to biological technology company colucid with $1 million in the middle, and finally recovered by Lilly with $960 million, He wrote the story of "abandoned son" becoming "Prince" in the field of new drug development (see: after 12 years, the new migraine drug lasmiditan returned to Lilly) < br / > No.7 AstraZeneca < br / > in April this year, AstraZeneca spent 6.9 billion US dollars to introduce the development and commercialization rights and interests of trastuzumab deluxtecan (ds-8201), an antibody coupling drug, from the first three companies in the world (excluding Japan) Surprisingly, just eight months later, the product was approved by the FDA to treat adult patients with unresectable or metastatic HER2 positive breast cancer who had previously received more than two HER2 targeted therapies < br / > AstraZeneca was approved in 2019 < br / > source: drug cube < br / > AstraZeneca launched three new drugs in China in 2019, They are Ling zeshu (linalopeptide capsule) for irritable bowel syndrome and constipation, yingfeifan (duvaliutab injection) for unresectable, stage III non-small cell lung cancer (NSCLC) patients without disease progression after chemotherapy and concurrent radiotherapy based on platinum drugs, and bectoreling Chang (budigfrey inhalation) for COPD patients Enter aerosol) < br / > in addition, the indications of AstraZeneca's tumor heavyweight drugs in China have been further expanded: oxitinib has been approved for the first-line treatment of EGFR mutation positive local advanced or metastatic non-small cell lung cancer (NSCLC) adult patients; olapari, a PARP inhibitor, has been approved for the first-line maintenance treatment of BRCA mutation advanced ovarian cancer patients < br / > No.8 the first three in total < br / > cetifloxacin is a broad-spectrum quinolones antibacterial drug, which was first approved for marketing in Japan on January 25, 2008, for the treatment of community-acquired pneumonia and urinary tract infection Sitafloxacin has not been approved for listing in the United States, and the approval process in China is relatively long It took 1629 days from August 2014 to the approval < br / > the first three drugs were approved in 2019 < br / > source: drug magic cube < br / > terrario (pexidartinib) is a colony stimulating factor-1 receptor (csf1r) inhibitor developed by the first three companies, which was approved by FDA in August this year for the treatment of adult patients with symptomatic tendon sheath giant cell tumor (TGCT) These patients' diseases cause severe functional limitations and cannot be improved by surgery It is worth mentioning that pexidartinib is the first and only approved treatment for TGCT < br / > No.9 Bayer < br / > Bayer will harvest a new drug in Europe, the United States and China in 2019 Thalidomide phosphate tablets / thalidomide phosphate for injection is an oxazolidinone antibiotic It was first developed by Dong-A pharmaceutical in South Korea After rolling, it authorized trius, cubist (Merck & CO) and Bayer to carry out commercial development Listed in the United States in June 2014, in the European Union in June 2015, and approved by China nmpa in March 2019, it is used for adult acute bacterial skin and skin structure infection caused by sensitive bacteria < br / > Bayer's new drug approved in 2019 < br / > source: medicine magic cube < br / > on July 30, FDA approved Bayer's nubeqa (darolutamide) to be on the market to treat non metastatic castration resistant prostate cancer (nmcrpc) patients Darolutamide, an androgen receptor antagonist, was awarded the FDA's priority review qualification in April this year The approval is three months ahead of the FDA's target action date < br / > vitrakvi (larotrecinib) was approved by FDA in November 2018 It is used to treat adult and child patients with locally advanced or metastatic solid tumors carrying ntrk gene fusion, without considering the occurrence area of cancer Larotrecinib is a targeted drug for ntrk1, NTRK2 or ntrk3 gene fusion It was first developed by Loxo oncology company Bayer obtained commercial rights and interests of larotrecinib in December 2017 with an advance of 400 million US dollars < br / > in September 2019, larotrecinib was approved by the European Union It is the first cancer drug approved by the European Union to be used for the treatment of cancer drugs with ntrk gene fusion, and for the treatment of local late and remote metastasis
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