First-line treatment of liver cancer, rare diseases new drugs have been accepted 2 innovative drugs Qi approved Chinese medicine new drugs are also on

The textEvathis week:three innovative therapies (two heavy-duty innovative drugs) in China were approvedChinese medicine re-power, another new drug on the marketrare disease new drug, Roche IL-6 antibody domestic declaration listedfirst-line treatment of liver cancer! The application for the listing of the first new drug, Donafini, was acceptedthis issue (May 9-15) domestic innovative drugs news, May 14 approved 3 innovative therapies, including 2 drugs and 1 device, in addition to new Chinese medicine on the market, breakthrough therapy accepted and other good news ..This week CDE has 50 acceptance numbers (28 varieties) reported production status updates, of which 23 status updates "issued", including the previous analysis of the new multiple sclerosis drug Sinimod tablets and the first stiletto drug, this issue also has 2 heavy innovative drugs and 1 new Chinese medicine approved More dynamics are as follows:Takeda Pharmaceutical's injection with vibututoxil monoantigen was officially approved for treatment of recurrent or refractory systemic transsexual large cell lymphoma (sALCL) and recurrent or refractory classic Hodgkin's lymphoma (cHL)The drug is the second ADC drug approved for the domestic marketVibututosizumab (English trade name: Adcetris) was developed by Takeda Pharmaceuticals and Seattle Genetics, USA, and was initially approved by the FDA in August 2011, and has been approved for six indications, including Hodgkin's lymphoma, primary skin degenerative large cell lymphoma, systemic interstited large cell lymphoma, sarcosarous tumor, and hematoma.comIn 2019, the drug's global sales reached $1.121 billionSo far, the FDA has approved eight ADC drugs to the marketIn addition, according to statistics, there are more than 60 ADC projects in the world into the clinical, involving indications including urinary skin cancer, three-yin breast cancer, HER2-positive breast cancer, glioblastoma and so onAt present, in addition to Roche's Enmetu toe-behraly (Hercel) and Takeda Vibutusia two ADC drugs approved, Pfizer has submitted the Ipo application of Iju mono-amoemistar and has been included in the priority review, is expected to become the third Domestic Listed ADC drugDomestic pharmaceutical companies, including Baiotai, Hengrui Pharmaceuticals, Colum pharmaceutical, Shanghai Pharmaceuticals and other more than 10 local pharmaceutical companies have layout ADC, of which, baiota's BAT8001 development is the fastest, in the clinical stage III, the adaptation is HER2-positive advanced breast cancer, is expected to complete the clinical study summary report and declare China's NDA in 2021 Noandlialutide injection cardiovascular indications have been approved and are the only sugar-reducing drug in China with reduced cardiovascular risk indications liraglutide, a glucagon-like peptide-1 (GLP-1) analogue developed by Novo Nordisk, has been approved in more than 100 countries worldwide and treats more than 1.2 million people with type 2 diabetes Since its launch, the drug's global sales have been rising year by year, and in 2018 global sales reached RMB28.875 billion, ranking 1st among all sugar-lowering drugs in the world in 2011 liraglutide was approved in China, the commodity named NoheLi, in July 2017 into health insurance, in 2018 its sales increased by 73% to DKK 521 million, accounting for 87% of the domestic GLP-1 market market, accounting for 1.3% of the overall diabetes market share The domestic liraglutide market is still dominated by Novo Nordisk, and successfully renewed the 2019 health insurance, it is expected that with the approval of new indications, Lilalutide is expected to further usher in a new sales record in recent years, domestic generic pharmaceutical enterprises have begun to exert their power, Shenzhen Hanyu, Jianxiang are to the new 4 categories of chemical drugs listed, nine source genes (East China Medicine) and Tonghua Dongbao is currently in phase III clinical In addition, domestic East Sunshine Medicine, China Biopharmaceuticals, Fosun Pharma and other domestic manufacturers are also in the layout The 6.1 class of Chinese medicine new drugs lianhua qing cough tablets declared by Ling Pharmaceuticals were approved by NMPA for the treatment of acute trachea and bronchitis even flower clear cough tablets is after the flower clear plague capsules / particles, to Ling pharmaceutical industry around the common diseases of the respiratory system acute trachea - bronchitis research and development of another innovative Chinese medicine, the efficacy of venting pulmonary fever, sputum cough, for acute trachea - bronchitis sputum fever lung certificate, symptoms are mainly cough, cough, sputum white or yellow, accompanied by fever, thirsty, thirsty, upset, and so on This week CDE new production acceptance number 21 (17 varieties), including 2 new drugs, 4 imported drugs, 11 generic drugs, the specific dynamics are as follows: Zeze Pharmaceutical development of the country's 1 class of new drug toluene donafini tablets of new drug listing application (NDA) has been officially accepted by the State Drug Administration (NMPA) this application is applicable to the treatment of patients with advanced (surgical or metastatic) hepatocellular carcinoma, mainly based on the results of the trial of ZGDH3, which is currently the first large sample (668 cases) in China's liver cancer patients HCC first-line standard treatment drug clinical trials, the results reached the preset main endpoint and safety results, showing better clinical results than Soraphini China is a well-known liver cancer country, about half of the world's liver cancer, its pathogenesis is complex, the current confirmed effective target drugs for liver cancer such as: Sorafeni, Rigofini, Levatinib are multi-target drugs, single-point drug research has failed In the 10 years from 2007 to 2017, the only approved target drug for liver cancer was Sorafeni It is expected that Donatini will bring new treatment options to front-line patients and bring good news to the vast number of liver cancer patients in our country in addition to the treatment of hepatocellular carcinoma, Dadone's treatment of advanced colorectal cancer and iodine refractory differentiated thyroid cancer, and the clinical study of Adonini and anti-PD-1 monoantigen treatment of advanced hepatocellular carcinoma are under way Roche's IL-6 antibody satralizumab listing application in China was accepted This application for indications is used as a single-drug therapy or in combination with immunosuppressants for the treatment of adult and adolescent patients with psynocoeur syndrome (NMOSD) Satralizumab, an all-humanized IL-6 monoclonal antibody developed by Roche At the end of 2018, the FDA granted its breakthrough therapy recognition, the European Union, Japan, etc also granted Satralizumab orphan drug eligibility NMOSD is a rare, lifelong, decaying autoimmune disease that characterizes inflammatory diseases of the optic nerve and spinal cord, affecting hundreds of thousands of people worldwide, and severe NMOSD seizures can lead to death In June 2019, Soliris (eculizumab), the first tonic inhibitor of rare disease giant Alexion, was approved by the FDA for use in adult patients with anti-water channel protein-4 (AQP4) antibody-positive psypan protosino protochveoid disorder (NMOSD) In August 2019, it will be approved by the European Union again In the United States and the European Union, Soliris is the first and only drug approved to treat NMOSD application for the drug's listing in China has been accepted, we look forward to the successful regulatory review of the drug to benefit NMOSD patients at an early date.