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    Home > Medical News > Latest Medical News > [Yao Kejun] Chunfeng brings good news: China's innovative new drugs go out of the country, national research heavyweight drugs have been approved for clinical application, and new progress has been made in frontier research

    [Yao Kejun] Chunfeng brings good news: China's innovative new drugs go out of the country, national research heavyweight drugs have been approved for clinical application, and new progress has been made in frontier research

    • Last Update: 2018-03-12
    • Source: Internet
    • Author: User
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    New drugs on the market: hypoglycemic drugs are on the market in China, and the world's first drug to reduce the risk of cardiovascular death by 38% A few days ago, the bringer Ingelheim Lilly diabetes Alliance announced that the world's first oral hypoglycemic drug (trade name: otangin ®) which can reduce the risk of cardiovascular death by 38% has been on the market in China The drug is the most comprehensive SGLT2 inhibitor approved in China at present It can be used as a single drug, combined with metformin or combined with metformin and sulfonylurea, which provides a powerful weapon for endocrinologists to better manage the cardiovascular risk of diabetic patients, and also provides a new option for the majority of diabetic patients to further improve the cardiovascular outcome on the basis of glucose reduction According to the pharmaceutical intelligence data, 17 domestic enterprises, including Nanjing Haina, Beijing lairuisen, Chengdu Yuandong, Jichuan pharmaceutical, Nanjing Huawei, founder Pharmaceutical Research Institute, Zhengda Tianqing pharmaceutical, Jiangsu Haosen, Shandong Luoxin, Sichuan Kelun, have applied for class 3.1 new drugs of engliptin API and its tablets, all of which have been approved for clinical application The competition of the first imitation of these enterprises is going on fiercely, and it is believed that more choices will be brought to the domestic patients in the near future Trogarzo, the first HIV treatment drug made in China, is on the market The era of long-term injection has been realized on March 6 The U.S Food and Drug Administration (FDA) approved the first HIV drug with a new mechanism developed by taimed and its partner theratechnologies in nearly a decade The total price of the drug is set at US $118000 per person per year It's the only treatment that doesn't require daily medication It is a kind of intravenous immunoglobulin G4 monoclonal antibody It binds to the second extracellular region of CD4 + T cell receptor to prevent HIV virus from invading these cells It is similar to pro140, but different from other binding sites of drugs that have been used on the market It is also the first sterile biological preparation produced in China and approved by FDA to enter clinical trials in the United States In the middle stage, taimed medical company has provided enough data According to the clinical trial database of smart drugs, the clinical trials of ibalizumab are shown in Figure 1 These data ensure the priority evaluation of this breakthrough therapeutic drug, thus reducing the time required for FDA inspection Ibalizumab has been awarded breakthrough therapy certification, priority review qualification, fast track qualification and orphan drug qualification by the US FDA Figure 1 The drug will be produced by Yaoming biological company in Shanghai The cGMP preparation factory for producing ibalizumab sterile biological products has recently been completed, which is located in the same park as the cell culture factory The preparation line adopts the international advanced automatic small volume aseptic filling system, which can produce 2-50ml liquid and freeze-dried bottle products, and flexibly meet the production needs of global clinical trials and product marketing FDA also completed the inspection and approval of the first Chinese manufacturing plant, laying the foundation for commercial promotion Recently, two priority approval projects of Guangzhou Wanfu Biotechnology Co., Ltd were listed After examination, the State Food and Drug Administration approved the listing registration of two products of "rubella virus IgG antibody detection reagent (fluorescence immunochromatography)" and "measles virus IgG anti physical examination reagent (fluorescence immunochromatography)" applied by Guangzhou Wanfu Biotechnology Co., Ltd These two products are the third category of medical device products in China, all of which are priority approval items The indirect method and the principle of fluorescence immunochromatography were used for qualitative detection of rubella virus IgG and measles virus IgG antibody in human serum or plasma in vitro It can be used in clinical diagnosis of rubella virus and measles virus infection After systematic evaluation, it is recommended to approve the registration of the application project The review and approval of Shanghai Pharmaceutical Co., Ltd two new drugs under development were approved at the same time On the evening of March 7, Shanghai Pharmaceutical Co., Ltd announced that the first class of original chemical drug hydroxytriptolide tablets (0.5mg, 1mg) jointly developed by Shanghai Pharmaceutical Research Institute of Chinese Academy of Sciences was approved for clinical use The indications were chronic abnormal immune activation of AIDS in the field of anti infection Figure 2 in addition, the recombinant anti HER2 humanized monoclonal antibody mcc-dm1 coupling agent for injection jointly developed by its wholly-owned subsidiary Shanghai cross linked drug research and Development Co., Ltd also obtained the clinical trial approval The drug is a cross-linked product of human monoclonal antibody and small molecule drug, which is intended to be used in HER2 positive local advanced or metastatic breast cancer Kadcyla ® (ADO trastuzumabemtanine, t-dm1) has been developed by Roche / immunogen Inc at present, domestic similar research is in the clinical exploration stage, and there is no similar product listed in China In 2017, kadcyla's overseas sales totaled 928 million US dollars Figure 3 progress in research and development to overcome sleep disorders Recently, Eisai and Purdue Pharma announced that the main results of many studies on lemborexant were positive Lamborexant is currently under study as an experimental drug for the treatment of multiple sleep disorders Lemborexant is a kind of orexin receptor antagonist It is a small molecule compound discovered and developed by Weicai company It can inhibit the neurotransmission of orexin by competitive binding with two subtypes of orexin receptor (orexin receptor 1 and 2) In patients with sleep disorders, the orexin system that regulates sleep and arousal may not function properly During normal sleep, orexin system activity is inhibited, indicating that inappropriate arousal can be purposefully suppressed, and the start and maintenance of sleep can be promoted by interfering with orexin neurotransmission New drugs to solve the jet lag are coming In this era of globalization, transnational travel has become the norm for business people However, travel across time zones can disturb people's biological rhythms, make people depressed during the day and hard to sleep at night Such a state is neither conducive to work nor to health On March 6, Vanda pharmaceuticals, a biotech company based in Washington, DC, announced good news that it had achieved good results in a phase 3 clinical trial of its new drug, hetlioz (tasimelteon), which was a step closer to being approved If all goes well, the new drug could bring good news to millions of people around the world who suffer from jet lag In the latest study, Vanda pharmaceuticals has identified jet lag as the main attack direction of hetlioz In a phase 3 clinical trial involving 318 healthy volunteers, the efficacy of hetlioz was confirmed Huntington's disease (hd) is a rare autosomal dominant genetic disease Recently, Ionis pharmaceuticals released biomarker data for a phase I / II study, which shows that the new drug Ionis httrx (rg6042) is the first new drug that can reduce the pathogenic protein in HD patients Onis-httrx is an innovative Anti Sense therapy targeting htt protein By binding to mRNA encoding htt protein, Ionis httrx can reduce the occurrence of all htt protein translation, so no matter where the gene mutation encoding htt occurs, the drug can reduce the production of toxic mhtt It has been awarded orphan drug qualification by FDA and European drug administration At the same time, the study also drove Roche, the pharmaceutical giant, to continue to pay $45 million in option fees to Ionis httrx (rg6042) In February this year, the Wall Street Journal published a report, which directly pushed the honey refining Chuanbei loquat cream, known as the "herbal supplement of honey and loquat" by the Americans, to the American hot search Alex schweder, a professor and architect at Pratt, the world's ninth largest art school, coughed for more than a week and began to take loquat cream 15 minutes later, the report said One stone arouses thousands of waves, and loquat cream becomes the topic center Recently, according to a number of media reprints of the Wall Street Journal, Chuanbei loquat cream has turned red and purple, and many people have said its magic effect, and the sales volume abroad has increased dramatically! However, according to domestic professionals, Chuanbei loquat cream is not a "magic drug" and can only play an auxiliary role in relieving cough In fact, according to the report, this loquat cream is introduced into the U.S market as a herbal dietary supplement The U.S Food and Drug Administration (FDA) recommends that consumers communicate with medical service providers before taking such supplements, and be alert to the exaggerated publicity of such products However, FDA has no right to review the safety and effectiveness of the supplements At present, many people like to use Chuanbei loquat cream when they have a cold and cough There are even reports that some people in the United States use Chuanbei loquat cream to spread sandwiches and make cocktails However, domestic professionals still remind you not to take them without permission You should differentiate according to the specific conditions Taking cough medicine without permission may lead to aggravation of the disease Content source: Yao mingkant, press release, medialliance, Wu Zhiying, new Beijing News, etc
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