In 2019 9 domestic 1 new drugs on the market!

(Source: NMPA)1, Lothian peptide - the first domestic long-acting GLP-1 agonist to be listed on the market
May, Jiangsu Howson independently developed a class 1 new drug polyglycol losenapeptide was approved by NMPA to be listed for adults to improve blood glucose control in patients with type 2 diabetes, becoming the first domestic long-acting GLP-1 preparation listed on the marketGLP-1 receptor agonists include short-acting and long-actingIn the current domestic approved short-term effects are Isenate peptide (2 times a day), liraglutide (once daily), Benalutide (3 times a day), lisna peptide (once daily);diabetes is one of the most serious health problems in the world, according to the International Diabetes Federation 2017 data, the number of adult diabetes cases in the world has reached 425 million, is expected to reach 629 million in 2045, China with 114 million people become the largest number of people with diabetesLong-acting GLP-1 receptor agonists are currently a hot research and development hotspot, and from the market performance, but also the fastest growth of the sugar-lowering drug market in a segmentThe global and Chinese GLP-1 agonists are expected to grow to $20.4 billion and $8.6 billion, respectively, by 2022, according to Forst and Sullivan2, Benvimod - domestic star psoriasis treatment drugsMay, NMPA approved the first class of innovative drug Benvimode cream (used by name: benzene mod, commodity name: Hinbik) listed for local treatment of adult light to moderate stability common psoriasisBen Vimod is a tyrosine protein kinase inhibitor developed by Beijing Wenfeng Tianji Pharmaceuticals, which can be therapeutic by inhibiting T-cell tyrosine protein kinase, interfering/blocking the release of cytokines and inflammatory media, T-cell migration and activation of skin cellsGlobally, new drugs for psoriasis have not been introduced for nearly 30 yearspsoriasis, commonly known as psoriasis, is a type of persistent disease in the skinAt present, there are about 8 million psoriasis patients and more than 80 million eczema patients, and is increasing year by yearSouthwest Securities research report pointed out that the domestic psoriasis market in more than 3 billion yuan, benzene mod is expected to replace the existing varieties, the development of more than 1 billion yuan of large varieties, in addition to psoriasis, Benvimod for eczema treatment market prospects are greaterIn July 2018, GSK announced that Dermavant Scientific had agreed to buy non-Chinese ownership of Benvimod, which is still in the clinical research phase, at a total value of $330 million, prompting intense concern, the Economic Daily reported3, alithromycin - domestic "super antibiotic"June, NMPA approved the Chinese Academy of Medical Sciences and Shenyang Tonglian Group jointly developed a new class of new drug Carrimycin (Carrimycin, commodity name: bit) listed for upper respiratory tract infectionscolycin is a large ring ester antibiotic for bacterial infection, developed using "synthetic biology technology", has been developed 16 domestic invention patents, 4 of which have been granted patents in the United States, Canada, Japan, South Korea, the European Union and other 12 PCT member countries, with 3 patentsthe drug has strong antibacterial activity, there is also significant inhibition activity on mycoplasma and chlamydia, and there is no significant cross resistance with similar drugsIn addition to the drug-resistant gramobacteria (such as methicillin-resistant Staphylococcus aureus and drug-resistant purulent streptococcus) and other effective, penicillin for some beta-lactamase-producing bacteria also have a good effect, some gram-negative bacteria (such as Clostridium difficile, influenza bacillus) and fungal white Candida also have better activityIn addition, the application of pentomycin in the anti-tuberculosis mycobacteria infection has been granted a domestic patentpentomycin has the advantages of low toxicity, low dose, low number of medicationand and convenience of taking, is the first choice for patients to pursue safe and effective drugs within the scope of adaptation, the effect is obviously better than the clinical first-line control drugs isoniazid and rifampycin4, flumartini - "upgraded" Grewe
In November, NMPA announced the approval of Hausson's class 1 new drug, methicilline (product name: flufort), for the treatment of chronic adult patients with chronic myeloid leukemia (Ph-CML) in PhiladelphiaMethasulta flumartinibinib is a tyrosine kinase inhibitor that is a second-generation TKI inhibitor drug for Bcr-Abl (a gene type) that, structurally, can be considered an upgraded version of GreviSales of chronic myeloid leukemia drugs in China reached RMB4.6 billion in 2018 and the market size is expected to grow to RMB14.2 billion by 2023, according to Frost and SullivanAs a domesticly listed second-generation Bcr-AblTKI inhibitor, Haussen flumartini will develop synergies with his own Imatinib in the field of chronic myeloid leukemia (CML) treatment, especially if the former can reach people who are resistant to Imatinibdetails "Explosion!" Howson Class 1 new drug fluoratinib is about to be approved for the market."5, glucosaccharide acid capsules - domestic Alzheimer's disease new drugearly November, NMPA conditional approval of ganlut sodium capsules (i.eGV-971, commodity name: phase 9 1) listed for the treatment of light to moderate Alzheimer's diseaseTHE GV-971, AN INNOVATIVE DRUG WITH INDEPENDENT INTELLECTUAL PROPERTY RIGHTS JOINTLY DEVELOPED BY SHANGHAI PHARMACEUTICAL RESEARCH INSTITUTE, OCEAN UNIVERSITY OF CHINA AND SHANGHAI GREEN VALLEY PHARMACEUTICALS, HAS POLARISED THE ATTITUDE OF THE OUTSIDE WORLD OVER ITS APPROVAL on the one hand, some people think that gv-971 market to fill the past 17 years in the field of Alzheimer's treatment no new drugs to the market gap, to provide patients with new drug options; 6, Carrey Pearl single resistance - the 3rd domestic PD-1 single resistance May, Hengrui Pharmaceuticals announced that its independent research and development of PD-1 Carrey Pearl monoantigen (commodity name: Erika) was officially approved by NMPA, for at least after the second-line system chemotherapy recurrence or treatment of the treatment of the treatment of the treatment of the treatment of the treatment of the classic Hodggold-type lymphoma, becoming the third domesticped PD-1 single resistance in addition, , Carrey Pearl in May and September, respectively, declared three new indications, respectively, the second-line treatment of hepatocellular carcinoma and esophageal squamous cancer, the first-line treatment of joint chemotherapy non-squamous NSCLC, the current Carreli Zhu is the most reported indications of domestic PD-1 monoantigen 7, Tyreli Zhu single anti- the 4th listed domestic PD-1 single resistance November, CDE has completed the PD-1 Pirelli Pearl single registration application of the technical review work, and has been submitted to NMPA for approval, the variety technical review recommendations for approval of production, indications for relapse / refractive classic Hodgkin's lymphoma (R/RcHL) Terelli Pearl Monoantigen is a human-derived monoclonal antibody developed by Baiji Shenzhou, is the first candidate drug developed by Baiji Shenzhou's immuno-oncology biological platform, and is currently being developed as a single-drug therapy and combination therapy for a range of solid tumor and blood tumor treatment indications Recurrent/incurable classic Hodgkin's lymphoma is the first declared indication of Terrey Zuma, and on June 3, its local late or metastatic urinary disease (UC) indication was also accepted by CDE, both of which were included in the priority review Among them, in the classic Hodgkin's lymphoma, the PD-1 objective remission rate (ORR) was highest in all domestic listings, at 87.1%, and total remission (CR) was 63% 8, Nirapali - the second domestic listed PARP inhibitor
In December, the first class of new drugs of re-ding medicine totoluene nilapapali (commodity name: Sule) has completed the technical review of the market, in the "approved" state, is expected to be approved for the market, indications for the full or partial mitigation of platinum chemotherapy for recurrent epithelial ovarian cancer, follicle cancer or primary peritone cancer adult treatment Nilapali is an efficient, selective daily oral PARP1/2 inhibitor In September 2016, Reeding Pharmaceuticals entered into a strategic cooperation agreement with TESARO to acquire exclusive research and development and sales rights in the Chinese market, and TESARO retains the option of possible participation in Nirapali's joint sales in China The drug was first approved in the United States in March 2017 and approved in Europe in November of the same year for the maintenance of patients with recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritonal cancer that have been fully or partially alleviated by platinum chemotherapy Based on the approval in the United States and Europe, Nirapali was approved for listing in Hong Kong, China, in October 2018 and Macau, China, in June 2019 three clinical trials in China have entered Phase III clinical trials, including platinum-sensitive relapsed ovarian cancer second-line maintenance therapy, first-line maintenance therapy and non-small cell lung cancer At present, the only APPROVEd PARP inhibitors in China are AstraZeneca's Olapari, and successfully entered the national health insurance directory, Nirapali will be the second on the domestic market for PARP inhibitors In addition, Hengrui's PARP inhibitor fluorozole pali has also recently been reported for the market 9, Remagleon - Hengrui 1 class of narcotic drugs
In December, NMPA official website shows that Hengrui's class 1 new drug Reimazolen listing review status changed to "in approval", is expected to be approved for listing soon toluene remagellaluon belongs to the benzodiazepine class, is a short-acting GABAa receptor agonist, suitable for intravenous general anesthesia during elective surgery Although Hengrui is listed as a class 1 new drug, it is not a completely original new drug, but on the basis of the old drug remaglin developed toluene-type compounds Remajunlun was originally developed as CeNeS in the United Kingdom, codenamed CNS7056, acquired by PAION in 2008, code-named ONO-2745, suitable for general anesthesia in elective surgery original title: New Drugs - 2019, these 9 domestic 1 class of new drugs on the market!