November New Drug Approval S: 8 U.S. China 2 EU 1 (Below)

Above, we described the eight new drugs approved in November 2019 and continue today09
Sodium OligomannurarateGallut sodium was approved by NMPA Condition on 2 November 2019 for the treatment of mild moderate Alzheimer's disease, named Phase 9 ®The drug was jointly developed by China Ocean University and the Shanghai Pharmaceutical Institute of the Chinese Academy of Sciences and later licensed to Shanghai Green Valley Pharmaceuticalsnerve inflammation induced by intestinal flora disorder is one of the important pathogenesis of Alzheimer's diseaseThere are about 10 million people living with Alzheimer's disease in China, the largest number of people in the worldWith the aging of the population accelerating, it is expected that by 2050 the number of patients in our country will reach 40 millionPhase 9 Phase 1 ® new oligosaccharides, which are extracted from marine plants, improve cognitive dysfunction by reshaping the balance of intestinal flora, reducing peripheral and central nerve inflammation, reducing beta amyloid deposition and tau protein excessive phosphorylationOctober 2018, at the 11th CTAD Conference, the Ganlutna Clinical Data was made public and showed a statistically significant improvement (p 0.0001) in the primary endpoint Alzheimer's disease assessment scale, the Cognitive Component Scale (ADAS-Cog12)At 36 weeks, the average difference in ADAS-Cog12 scores between the treatment group and placebo was 2.54the listing of the nine-phase ®, filling the field for many years without innovative drugsHowever, the clinical efficacy of the nine-phase ® has been questioned by academic circles at home and abroadThe drug needs to continue to conduct extensive clinical trials to provide further evidence of efficacy10
FlumatinibFlumatinib, developed by Jiangsu Howson, was approved by NMPA on November 26, 2019 for the treatment of chronic myeloid leukemia (Ph-CML), a product called Haussen's ® CML, also known as chronic leukaemia, is characterized by bone marrow preparation of excessive white blood cells, often mixed with chromosome 9 ABL and 22 stained BCR into the Philadelphia chromosome CML is divided into three periods, chronic period, acceleration period and rapid change period According to the latest statistics from the American Cancer Society, there were 8,990 new diagnoses of CML in the United States in 2019, and about 1,140 patients died from CML In addition, 15% of new leukemias are CML, and 1/526 Americans will develop CML Haussen ® is a second-generation tyrosine kinase inhibitor (TKI) that inhibits the activity of Bcr-abl tyrosine kinase in cells 's approval for the Haussen ® was based on an open label, randomized phase III trial (NCT02204644), in which 400 patients were randomly accepted for flumatinib or imatinib In the 6th month after treatment, the remission rate was 35.2% in the flumatinib group, 19.3% in the imatinib group (p-0.0002), and in the 12th month, 57.2% and 39.2% (p-0.001) ( 34) flumatinib has achieved second-generation TKI levels compared to the imatinib of the first generation OfKI, and the security has improved significantly Flumatinib inhibits wild types and common mutations more powerfully, and the aBL kinase selectivity resistant to imatinib is better than the usual TKI, and the phenomenon of "off-targeting" is less 111 rVSV-EBOV Mersadong, rVSV-EBOV, has been approved by the EUROPEAN Union EMA conditions in November 2019 to prevent Ebola virus infection, named Ervebo ® In addition, the vaccine is in the FDA's priority review phase and the final results are expected in March 2020 rVSV-EBOV was originally developed by the Public Health Agency of the National Microbiology Laboratory of Canada, after which NewLink Genetics acquired the technology and granted Mercado the right to research and development and marketization Ebola virus infection is a rare and extremely serious disease In the past outbreak, the mortality rate was between 25 and 90% The worst outbreak to date was in West Africa in 2014-16, with more than 11,000 deaths At present, the continuing outbreak in the Democratic Republic of the Congo has a fatality rate of about 67 per cent According to the WHO report in July 2019, the number of people infected now exceeds 3,000 and there is no cure Ervebo ® is a detoxifying recombinant ostosis virus (rVSV) that replaces the membrane protein gene of VSV with the surface glycoprotein of the Zaire Ebola virus Ervebo ® was approved based on clinical use in the event of an outbreak of Ebola virus infection in West Africa Ervebo ® showed good immunity, safety and efficacy against Ebola in 16,000 individuals vaccinated Ervebo ® was developed in collaboration with Canadian laboratories, Mersadong, WHO and other agencies, and is another breakthrough after China approved the adenovirus vector Ebola vaccine in 2017 References
1 Drug transfer data: (accessed November 2019) 2 Zelop C, Benacerraf BR The cause and the natural history of the ascites Prenat Diagn 1994; 14: 941–946 2 3 Enders M Fetal morbidity and mortality after human parvovirus B19 infection inbei: prospective evaluation of 1018 cases Prenat Diagn 2004; 24:513–518 4 FDA Database pdf (accessed November 2019) 5 Drug Data: (accessed November 2019) 6 Galanello R, Origa R Beta-thalassemia .J Orphanet Journal of Rare Diseases, 2010, 5 (1): 1-15 7 FDA Database (accessed November 2019) 8 Drug Data: (accessed November 2019) 9 Sabih A, Leslie S W M Mayinary Tract Infections (M)/StatPearls (Internet) Stat Pearls Publicing, 2019 10 Community Consensus on diagnosis and treatment of urinary tract infections China Expert Consensus - Consensus of Chinese Experts on Diagnosis and Treatment of Urinary Tract Infections (2015 edition) - Complex Urological Infections (J) Chinese Journal of Urology, 2015, 36 (4):241-244.
11 FDA Database (accessed November 2019) 12 Drug Data: (accessed November 2019).
13 American Cancer Society 14 FDA Database pdf (accessed November 2019) 15 Drug Crossing Data: html (accessed November 2019) 16 Novartis: New Novartis na Adakveo ® (crizanlizumab) approved by FDA to reduce y frequenc of pain s in individuals livingsickle cell disease 17 FDA Database pdf (accessed November 2019) 18 Drug data: (accessed November 2019) 19 Wu Huimin, Hua Jing Assessment and long-term management recommendations for acute hepatic rickets Liver, 2018 20 FDA Database pdf (accessed November 2019) 21 Drug data: (accessed November 2019) 22 SK Corporation (Accessed November 2019) 23 FDA Database pdf (accessed November 2019) 24 Drug Data: html (accessed November 2019)
25 CDC website Sickle Cell Disease (SCD) Html (Accessed June 3, 2019) 26 Global Blood Therapeutics: (Accessed November 2019) 27 FDA Database pdf 28 Drug data: html (accessed November 2019) 29 Green Valley Pharmaceuticals html (accessedNovember 2019) 30 Novel Drug Treatment Show Show Cognitionin a Phase 3 Clinical Trial In Persons with Mild-to-Moderate Alzheimer's Disease in China, 2018/10 31 Drug Data: html (accessed Novembered 2019) 32 American Cancer Society: http:// 33 Jiangsu Howson: http://www.
.html 34 Flumatinib Show Promise in Chronic-Phase Chronic Myeloid American Society of Clinical Oncology (ASCO) June 2, 2019 35 Drug Ferry Data: html (accessed November 2019) 36 Merk's website (accessed November 2019) 37 EMA official website First vaccine to protect againstEbola Pressrelease 18/10/2019 (Accessed November 2019) 38 EMA official website Ervebo (accessed November 2019) original title : Global Approval of New Drugs in November 2019: 8 in the United States, 2 in China, 1 in the European Union (below)