Review of 39 new biological drugs on the market in 2018

The 21st century is the century of life science At present, more than half of the academicians of the American Academy of sciences are engaged in research in the field of life science; more than half of the federal government's budget for funding scientific research is used for research in life science Therefore, compared with chemical drugs, biological drugs are developing more and more rapidly in the field of human disease treatment Biotechnological drugs are called Biopharmaceutics for short They are mainly divided into recombinant protein drugs, recombinant polypeptide drugs, recombinant DNA drugs and stem cell therapy drugs It is estimated that in 2022, the global biopharmaceutical market will reach 326 billion US dollars At the same time, Frost & Sullivan predicted that China's biopharmaceutical market would reach 326.9 billion yuan in 2021 In 2018, 93 new drugs were launched in the world There are 54 chemical drugs and 39 biological drugs First of all, let's take a comprehensive look at the targets and R & D information of these 39 drugs: 1 The caplacizumab developed by caplacizumab Ablynx was approved by EMA on August 31, 2018, with the trade name of cablivi ® It is a nanoantibody against von Willebrand factor and is approved for the treatment of acquired thrombocytopenic purpura (TTP) 2 Darvadstrocel darvadstrocel was approved by EMA on March 23, 2018, and its trade name is alofisel ® It is a fat cell allogeneic replacement therapy, which contains human allogeneic mesenchymal stem cells extracted from fat This product is approved for the treatment of anorectal fistula 3 Ys-on-001 ys-on-001 is developed and marketed by Yisheng biology, with the trade name of yiweika ®, which was approved for marketing in Cambodia in 2018, and is used to treat breast cancer, colorectal cancer, liver cancer, lung cancer and gastric cancer and other solid tumors 4 Etanercept biosimilar Etanercept biosimilars developed by Zhitian Pharmaceutical Co., Ltd were approved for marketing by PMDA on January 19, 2018 Etanercept biosimilars are tumor necrosis factor (TNF) blockers that can specifically bind to TNF molecules and inhibit the binding of TNF - α and TNF - β to TNF receptor on cell surface It is used to treat rheumatoid arthritis and juvenile idiopathic arthritis 5 Adalimumab biosimilar Hulio ® fkb-327 was developed by Fuji Union and Kirin biology Co., Ltd and was approved by EMA for listing in October 2018, with the trade name of Hulio ® It is an all human IgG1 type of adalimumab targeting at tumor necrosis factor α, which is approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, purulent sweat adenitis, Crohn's disease, ulcerative colitis, uveitis, juvenile rheumatoid arthritis and plaque psoriasis 6 Adalimumab biosimilar Hefiya® It is a biologically similar drug of adalimumab, which was approved by EMA on July 26, 2018 and developed by Sandoz company It is a tumor necrosis factor α (TNF α) inhibitor and approved for the treatment of spinal arthritis, uveitis, purulent sweat adenitis, psoriasis, juvenile idiopathic arthritis, psoriatic arthritis, papule squamous dermatosis Crohn's disease, ulcerative colitis and plaque psoriasis in children 7 Romosozumab romosozumab has been approved by EMA for marketing in January 2018 The trade name is evenity ® which is a monoclonal antibody targeting at sclerotin and is approved for the treatment of osteoporosis in postmenopausal women with high fracture risk and men with high fracture risk 8 Andexanet Alfa developed by andexanet Alfa Portola Pharmaceutical Co., Ltd has been approved by FDA for listing on May 3, 2018, and its trade name is andexxa ® It is a recombinant and modified coagulation factor Xa, which can combine with rivaroxaban and apixaban, the inhibitors of coagulation factor Xa, so as to play a role in promoting coagulation The drug is approved for reverse anticoagulation in patients treated with rivaroxaban and apixaban for life-threatening or uncontrollable bleeding 9 Pegvaliase-pqpz pegvaliase-pqpz was approved by FDA on May 24, 2018 It is a recombinant phenylalanine metabolizing enzyme, which is composed of recombinant phenylalanine aminolyase and N-hydroxysuccinimide (NHS) - methoxypolyethylene glycol (PEG) It can convert phenylalanine into ammonia and trans cinnamic acid The product is used to reduce the blood phenylalanine concentration of phenylketonuria patients (the blood phenylalanine concentration exceeds 600 μ mol / L) 10 On September 28, 2018, cemiplimab was approved by the FDA for marketing Its trade name is libtayo ®, which is a PD-1 monoclonal antibody It is approved for the treatment of metastatic skin squamous cell carcinoma (CSCC) or locally advanced CSCC patients who cannot receive curative surgery or radiotherapy 11 Sintilimab Sindilimab (ibi-308) is a PD-1 developed by Cinda biology, which is used for the treatment of relapsed or refractory classic Hodgkin's lymphoma after at least second-line system chemotherapy It was approved for marketing by nmpa on December 27, 2018 under the trade name of dabushu (tyvyt ®) In addition, it is used for the treatment of advanced or metastatic squamous non-small cell lung cancer, adenocarcinoma at the junction of stomach and stomach and esophagus Now In clinical stage III 12 Toripalimab trepril monoclonal antibody (js001) is named tuoyi ® On December 17, 2018, the application for listing of trepril monoclonal antibody injection was approved by nmpa to become the first PD-1 monoclonal antibody independently developed in China It is a humanized monoclonal antibody developed by Shanghai Junshi Biomedical Technology Co., Ltd and Suzhou Zhonghe Biomedical Technology Co., Ltd (Junshi biological subsidiary) It is targeted at programmed death receptor 1 (PD-1) It is used to treat unresectable or metastatic melanoma patients who have received systemic treatment failure in the past It is intended to be used to treat breast cancer, lymphoma, and malignant melanoma Sex melanoma, urogenital system cancer and other kinds of solid tumors, 13 Velmanase alfa, developed by velmanase Alfa zymenex (a subsidiary of chiesi farmaceuti), was approved by EMA on March 23, 2018 and listed under the trade name of lamzede ® It is a recombinant α - mannosidase, which can supplement or replace natural α - mannosidase to reduce the storage of mannose The drug is approved for the treatment of mild to moderate alpha mannoside storage 14 Lanadelumab lanadelumab was approved by FDA on August 23, 2018, and its trade name is takhzyro ® It is a human monoclonal IgG1 antibody targeting at plasma kallikrein (pkal), which is used to prevent the onset of angioedema in patients aged 12 and over with hereditary angioedema (HAE) 15 The meningococcal A / C vaccine developed by meningococcal A / C vaccine was approved by nmpa on March 20, 2018 Group A and group C meningococcal vaccines are approved for the prevention of epidemic cerebrospinal meningitis caused by group A and group C meningococci 16 House dust mite allergy immunotherapy, developed by lofarma, was approved for marketing in 2018 Its trade name is Lais mites sublingual tables ® It is an immunotherapy approved for the treatment of allergic asthma, rhinitis and rhinoconjunctivitis 17 Tagraxofus tagraxofus Erzs was approved for marketing by FDA in December 2018, and its trade name is elzonris ® The drug is a cytotoxin targeting CD123 It is a recombinant fusion protein formed by some fragments of interleukin-3 and diphtheria toxin The drug is approved for the treatment of acute plasmacytoid dendritic cell tumor (bpdcn) in adults and children over 2 years old 18 Tildrakizumab aSMn tildrakizumab aSMn was approved by FDA on March 20, 2018, and then approved by EMA on September 17, 2018 Ilumya ®, a humanized IgG1 - κ monoclonal antibody, targets P19 subunit of interleukin 23 (IL-23), and blocks the interaction between P19 subunit and IL-23 receptor The drug is approved for the treatment of moderate to severe plaque psoriasis in adults 19 Emapalumab was approved by FDA on November 20, 2018 The drug, developed and sold by novimune SA and marketed as gamifant ®, is an all human monoclonal antibody targeting interferon - γ (IFN - γ) and approved for the treatment of adult or infant patients with primary Haemophilus lymphohistiocytosis (HLH) 20 Recombinant cytokine gene derived protein
This product was developed by Jiehua biology and approved by nmpa on April 12, 2018 It is a recombinant cytokine gene derived protein Its structure is very different from the natural interferon sequence, which can inhibit virus replication, enhance antiviral immunity, at the same time, it can also enhance self immunity and inhibit tumor cell proliferation and tumor vascular growth, so as to block tumor Blood supply for the treatment of chronic hepatitis B 21 Trastuzumab biosimilar kanjinti ® was approved by EMA on May 16, 2018 and PMDA on September 21, 2018 The product is a biological analogue of trastuzumab, a humanized IgG1 monoclonal antibody targeting HER2, which is used to treat HER2 + early breast cancer and gastric cancer 22 Trastuzumab biosimilar trazimera ® is a biological analogue of trastuzumab, which was developed by Pfizer company and approved by EMA on July 26, 2018 It is a humanized IgG1 monoclonal antibody It binds to HER2 on tumor cells and mediates antibody dependent cytotoxicity (ADCC) The drug is used to treat breast cancer with overexpression of HER2, metastatic gastric cancer with overexpression of HER2 or adenocarcinoma at the junction of esophagus and stomach 23 Agalysidase beta biosimilar JCR pharmaceuticals developed by agalysidase beta biosimilar JCR pharmaceuticals was approved for marketing by PMDA on September 21, 2018 Agassidase β is a recombinant galactosidase α, which has been approved for the treatment of Fabry's disease 24 Condoliase condoliase was developed by biochemical industry Co., Ltd and was approved by PMDA for listing in March 2018, with the trade name of hernicore ® It is a glycosaminoglycan degrading enzyme that can induce the dissolution of chondroitin-6 sulfate proteoglycan in intervertebral disc tissue The product is approved for the treatment of disc displacement 25 Burosumab twza, originally developed by Kyowa Hakko Kirin, has been approved by EMA on February 19, 2018, and approved by FDA on April 17, 2018 It is a kind of all human IgG1 monoclonal antibody targeting fibroblast growth factor 23 (FGF23) and approved for the treatment of X-linked hypophosphatemia (XLH) This is the first orphan drug approved to treat X-linked hypophosphatemia (XLH) in children and adults aged 1 and over 26 Damotocog Alfa pegol jivi ® (damotocog Alfa pegol), a polyglycolic recombinant human coagulation factor VIII developed by Bayer, was approved by FDA on August 29, 2018 Jivi ® is a recombinant factor VIII (rFVIII) replacement therapy, which can replace the missing coagulation factor VIII Jivi ® is approved for haemophilia A in previously treated adults and adolescents (12 years and older) for on-demand treatment and control of bleeding events; perioperative bleeding; and routine prevention to reduce the frequency of bleeding episodes 27 Thiopefigeristine, developed by mecapegfilgrastim Jiangsu Hengrui, has been approved for listing by nmpa on May 8, 2018, with the trade name of aido ® The product is a PEGylated recombinant granulocyte colony stimulating factor for chemotherapy-induced neutropenia 28 Pegfilgrastim biosimilar (cinfa biotech) was approved by EMA on November 20, 2018 It is a subcutaneous injection solution with pegylated recombinant granulocyte colony stimulating factor as the active ingredient for the treatment of neutrophils caused by chemotherapy