New drug approval in November: 8 in the United States, 2 in China, 1 in the European Union

In November 2019, the world's first approval of new drugs mainly concentrated in the United States, China and the European Union Us food and Drug Administration (FDA) approved six new molecular substance (NME) as contrast agent air polymer type for the detection of fallopian tube patency A Cefiderocol for the treatment of complex urinary tract infection, zanubrutinib for the treatment of mantle cell lymphoma, givosiran for the treatment of acute intermittent porphyria, cenobamate for the treatment of partial seizure epilepsy and voxelotor for the treatment of sickle cell anemia The National Drug Administration (nmpa) approved two NME drugs, namely, the sodium oligoannurate for Alzheimer's disease and flumatinib for chronic myeloid leukemia In addition, FDA approved two new biological products, namely, lustatercept for the treatment of thalassemia and crizanlizumab for the treatment of sickle cell anemia The European Drug Administration (EMA) approved a new vaccine for the prevention of rbsv EBOV infection We have introduced the 8 new drugs approved in November 2019, and continue today Mannose sodium was approved by nmpa on November 2, 2019 for the treatment of mild to moderate Alzheimer's disease, and the trade name is phase 9-1 The drug was jointly developed by Ocean University of China and Shanghai Institute of medicine, Chinese Academy of Sciences, and later authorized to Shanghai Lvgu pharmaceutical [28] The neuroinflammation induced by intestinal flora disorder is one of the important pathogenesis of Alzheimer's disease There are about 10 million people with Alzheimer's disease in China, which is the largest number of patients in the world With the acceleration of population aging, it is estimated that the number of patients in China will reach 40 million by 2050 [29] Phase 9-1 ® is a new oligosaccharide drug extracted from marine plants It can reduce peripheral and central nervous inflammation, β - amyloid protein deposition and tau protein hyperphosphorylation, and improve cognitive dysfunction by reshaping the balance of intestinal flora In October 2018, at the 11th ctad meeting, the clinical data of manntner was disclosed, which showed a statistically significant improvement (P < 0.0001) in the main endpoint of Alzheimer's disease rating scale cognitive subscale (ADAS cog12) At 36 weeks, the mean difference between the treatment group and placebo in ADAS cog12 score was 2.54 [30] The listing of phase IX and phase I has filled in the situation that there has been no innovative drugs in this field for many years However, the clinical efficacy of nine phase one ® has been questioned by the academic circles at home and abroad The drug needs to continue to carry out a wide range of clinical trials to provide further evidence for efficacy Flumatinib, developed by Haosen, Jiangsu Province, was approved by nmpa on November 26, 2019 for the treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph + CML), trade name is Haosen Xinfu ® [31] CML, also known as CML, is characterized by excessive white blood cells prepared from bone marrow It is often fused into Philadelphia chromosome by ABL on chromosome 9 and BCR on chromosome 22 CML can be divided into three periods: chronic, accelerated and cataclysmic According to the latest statistics of the American Cancer Association, 8990 new CML cases were diagnosed in the United States in 2019, and about 1140 patients died of CML In addition, 15% of new leukemia is CML, and 1 / 526 of Americans will suffer from CML [32] Hausen Xinfu ® is a second generation tyrosine kinase inhibitor (TKI), which can inhibit the activity of BCR ABL tyrosine kinase in cells [33] Hausen Xinfu ® was approved on the basis of an open label, randomized phase III trial (nct02204644) in which 400 patients were randomized to flumatinib or imatinib At the 6th month, the remission rate was 35.2% in flumatinib group and 19.3% in imatinib group (P = 0.0002); at the 12th month, 57.2% and 39.2% respectively (P = 0.001) [34] Compared with the imatinib of the first generation TKI, flumatinib has reached the level of the second generation TKI, while the security has been improved significantly Flumatinib has a stronger inhibitory effect on wild-type and common mutations, and the selectivity of ABL kinase resistant to imatinib is better than that of TKI, and the phenomenon of "Miss target" is less The rvsv-ebov developed by MSD has been approved by the European Union EMA in November 2019 for the prevention of Ebola virus infection Its trade name is ervebo ® In addition, the vaccine is in the FDA's priority review stage, and the final results are expected in March 2020 RVSV EBOV was initially developed by the public health agency of the National Microbiology Laboratory of Canada, and then newlink genetics obtained relevant technologies and granted the R & D and marketization rights of MSD [35,36] Ebola virus infection is a rare and extremely serious disease In the past, the mortality rate of patients was between 25% and 90% The most serious outbreak so far was in West Africa in 2014-2016, with more than 11000 deaths At present, there is a sustained outbreak in the Democratic Congo, with a fatality rate of about 67% According to the report of who in July 2019, at present, the number of infected people has exceeded 3000, and there is no treatment [37] Ervebo ® is a attenuated recombinant vesicular stomatitis virus (rVSV), replacing the membrane protein gene of VSV with the surface glycoprotein of Zaire Ebola virus [38] The approval of ervebo ® is based on the clinical efficacy of the Ebola virus in West Africa Ervebo ® showed good immunity, safety and efficacy against Ebola in 16000 vaccinated individuals [36] The R & D of ervebo ® was facilitated by the cooperation of Canadian laboratories, MSD, who and other institutions It is another breakthrough achievement after China approved the adenovirus vector Ebola vaccine in 2017.