Who is more innovative in the 32 domestic batch-produced "China Class 1 New Drugs"? !
Last Update: 2020-06-19
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Caption < br / > recently, from domestic conditional approval of gv-971 to US FDA batch production of zebotinib, the efficacy of domestic innovative drugs once again ignited the discussion in the pharmaceutical industry< br / > since 2001, about 32 "China's class 1 new drug" chemicals have been approved for listing by China's drug regulatory authoritiesAmong these varieties, which are derived from real independent research and development, which are derived from excellent introduction and development, and which are truly reflected in outstanding innovation strength, and what is their degree of intellectual property protection? With the above questions, this manuscript sorts out the following categories< br / > 1From 2019 to now / 4 domestic class 1 new drugs < br / > from 2019 to now, 4 class 1 new drugs have been batch produced by the domestic drug regulatory department, which are gv-971, colistin, pegylated loseptide and benwemod respectivelyThere is no doubt that gv-971 is the most popular topic in the domestic pharmaceutical industry< br / > the oligosaccharide new drugs extracted from the marine plants were approved by the domestic drug administration in November 2019 for the treatment of mild to moderate Alzheimer's disease< br / > developer: Ocean University of China, Shanghai Institute of medicine, Chinese Academy of Sciences, Shanghai Green Valley Pharmaceutical Co., Ltd< br / > related patent: cn1408360a< br / > carramycin < br / > antibiotic drugs, approved by the domestic drug regulatory department in June 2019, are used for the treatment of upper respiratory tract infection< br / > developer: Institute of pharmaceutical biotechnology, Chinese Academy of Medical Sciences, Shenyang Tonglian Group Co., Ltd< br / > related patents: cn201010229139.5, cn201310082805.0, cn201110136228X, cn201511030787.7, cn201811132964.6, cn201110265025.0, cn201511028754.9, etc< br / > peg loxenatide < br / > long acting GLP-1 receptor agonist, which is the first independently innovated long acting GLP-1 receptor agonist in China and the first PEGylated long acting GLP-1 receptor agonist in the world, is used to improve the blood glucose control of adult type 2 diabetes patients< br / > developer: Jiangsu Haosen Pharmaceutical Co., Ltd< br / > related patents: cn103492412b (core), wo2017cn106355, etc< br / > benvitimod < br / > therapeutic aromatic receptor modulator, approved by the domestic drug regulatory department in May 2019, is the first innovative generation of non hormonal new small molecule chemicals for the treatment of inflammatory and autoimmune diseases in the world< br / > developer: Hebei Wenfeng< br / > related patents: wo2000ca01433, cn2015174560, etc< br / > 2In 2018 / 6 domestic class 1 new drugs < br / > 6 domestic class 1 new drugs were batch produced in 2018, including losartan, furaquinidine, pyrrolidine, danorivir sodium, ibovetai and enrotinibThe author believes that the domestic class 1 new drugs approved in 2018 have a relatively large number of focuses and good quality as a whole; the indications involve tumors, HIV, HCV, hematopathy, etc.; the targets are also hot as a whole; if you carefully inquire about the relevant clinical trial design and development, it is more material< br / > roxadustat < br / > hypoxia inducible factor proline hydroxylase (hif-ph) inhibitorIn December 2018, roxadusta was approved to be listed by the domestic drug regulatory department for the treatment of anemia caused by chronic kidney disease in patients undergoing dialysis treatmentIn August 2019, losartan was approved in China to treat anemia caused by non dialysis dependent chronic kidney disease< br / > developers: fibrogen, AstraZeneca, Astaire < br / > related patents: Compound patents wo1998us22704, wo2004us17773, wo2004us17773, us20060455200, wo2007us14157, wo2012us21363, wo2012us64140, wo2013us29851, wo2013us50538, tw20140105840, wo2014us41021, etc< br / > Fu fruquintinib < br / > oral inhibitor of vascular endothelial growth factor receptor (VEGFR)It was listed by the domestic drug regulatory department in September 2018, and the approved indication was metastatic colorectal cancer< br / > developer: Hutchison Whampoa medicine, Lilly< br / > related patents: cn101575333b, wo2009us43347, wo2015cn89035, etc< br / > pyrotinib maleate < br / > UBI erbB receptor tyrosine kinase inhibitor, approved by the domestic drug administration in August 2018, is used to treat HER2 positive metastatic breast cancer patients< br / > developer: Jiangsu Hengrui < br / > related patents: wo2007cn00256, wo2010cn01293, wo2012cn71015, wo2013cn76717, wo2017cn72212, wo2017cn72156, wo2017cn72155, wo2017cn102861, wo2018cn73386, etc< br / > danoprevir sodium < br / > NS3 / 4A protease inhibitor, approved by the domestic drug regulatory department in June 2018, was approved to be used in combination with pegylated interferon and ribavirin to treat hepatitis C < br / > developer: Roche, array biopharma, Geli China < br / > related patents: wo2004us33970, wo2008ep54518, wo2008us62552, wo2008ep56521, wo2008ep67309, wo2009ep53711, wo2009us40565, etc < br / > albuvirtide (ibovetai) < br / > HIV-1 fusion inhibitor, approved by the domestic drug administration in May 2018, is used in combination with other antiretroviral drugs to treat HIV-1 infected people who still have virus replication after antiviral treatment < br / > developer: Frontier biology < br / > related patents: wo2003us29815, cn20101142574, etc < br / > anlotinib dihydrochloride < br / > a multi-target tyrosine kinase inhibitor Its mechanism of action is similar to that of sorafenib and pezopanil, and its molecular structure is similar to that of sildenab, cabotinib and sunitinib In May 2018, it was approved by the domestic drug regulatory department to be put on the market for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who developed or relapsed after receiving at least two kinds of systematic chemotherapy in the past < br / > developer: Zhengda Tianqing, advanchen laboratories < br / > related patents: wo2008us54816, cn20101245688, wo2015cn80870, wo2015cn80863, wo2015cn80859, wo2015cn96777, wo2015cn96776, wo2017cn70352, wo2017cn80563, etc From 2013 to 2017, seven new class 1 drugs were approved in China, including nilaparil, heimpofen, ninofloxacin, sidabamide, apatinib, molinnidazole and alisartan ester Among them, the relatively hot varieties are nilaparil approved in 2017, siddabenzamine and apatinib approved in 2014 For example, nilaparil is a PARP inhibitor, which is more popular in women's tumors; the recent expansion information of sidabamide has attracted more attention in the industry; and the patent dispute case of apatinib is still concerned by the industry, etc < br / > niraparib < br / > polyadenyldiphosphate ribose polymerase 1 / 2 (PARP-1 and PARP-2) inhibitors were approved by the U.S Food and Drug Administration in March 2017, and then approved by the European Drug Administration in November 2017 Tesaro is responsible for marketing in the U.S and the European Union The product name is zejula ® In October 2018, zaiding pharmaceutical announced that nilapari was approved to be listed in Hong Kong, China, and its Chinese name is zele ® In December 2018, the application for production in Chinese mainland was accepted by the domestic drug administration It is approved for the maintenance treatment of recurrent epithelial ovarian cancer, salpingocarcinoma and peritoneal cancer, and adult patients who respond completely or partially to platinum chemotherapy developers: moshadong, Tesaro, heding medicine, Yang Sen, Takeda, GlaxoSmithKline related patents: WO2007GB50177, WO2009GB00041, WO2013US72711, WO2013US72710, US201514726682, WO2017US40039, WO2018US13029, WO2018US24603, WO2018US24597, WO2018US29131, WO2018US31876, WO2018US33437, etc < br / > hermoporfin < br / > photodynamic therapy for port wine stains was approved by the domestic drug regulatory department in September 2016 This product was developed and sold by Shanghai Fudan Zhangjiang biomedical Co., Ltd the product is named fumida ®, approved for the treatment of port wine stains and became the first drug approved for the treatment of port wine stains in the world < br / > developer: Shanghai Fudan Zhangjiang biomedicine < br / > related patent: us20100848755, etc < br / > nemonoxacin malate < br / > type II DNA topoisomerase inhibitor, approved by the domestic drug administration in May 2016, is used to treat community-acquired bacterial pneumonia < br / > developer: Taijing biotechnology, r-pharm, Zhejiang medicine < br / > related patents: wo1995us09647, wo2007ib51055, wo2008us72210, wo2008us75549, wo2009us49364, wo2009us50241, wo2009us67817, etc < br / > chidamide < br / > histone deacetylase (HDAC) inhibitor, approved by the domestic drug administration in December 2014, is used for the treatment of recurrent or refractory peripheral T-cell lymphoma < br / > developer: micro core biology, huashangshengyi < br / > related patents: wo2004ib00401, wo2014cn80585, etc < br / > apatinib mesylate (apatinib mesylate) < br / > oral tyrosine kinase inhibitor, approved by the domestic drug administration in October 2014, is used for the treatment of metastatic gastric cancer < br / > developers: advanchen laboratories, Jiangsu Hengrui, HLB life science, LSK biopharma < br / > related patents: wo2004us17915, wo2009cn72239, cn201710645483, cn201710754993, cn201710841641, wo2017cn105410, wo2017cn113899, etc < br / > morinidazole (morpholinidazole) < br / > nitroimidazole antibiotics, approved by the domestic drug administration in February 2014, are suitable for the treatment of appendicitis and pelvic inflammation caused by sensitive anaerobic bacteria < br / > developer: Jiangsu Haosen pharmaceutical < br / > related patents: cn1605586, cn100344626c, cn100427094c, cn104829541a, cn104844522a, etc < br / > Allisartan isoproxil (alisartan ester) < br / > angiotensin II receptor antagonist, approved by the domestic drug administration in October 2013, is used for the treatment of hypertension < br / > developer: Shanghai Ellis, xinlitai < br / > related patents: wo2006cn01914, wo2006cn03301, wo2008cn00048, wo2008cn71213, wo2008cn01715, wo2009cn00629, wo2014cn89775, wo2015cn79352, wo2015cn80914, wo2015cn82994, etc < br / > 4 As early as 2011, three new class 1 drugs were approved in 2011 / China, namely, three new class 1 drugs, namely, iramod, exetinib and iricoxib There is no doubt that Berta's ektinib is relatively well known, especially in the process of healthcare negotiations in recent years In fact, the development strategy of elamud was also very avant-garde at that time, and it is worth learning from domestic pharmaceutical companies < br / > Iguratimod (alamod) < br / > an inhibitor of NF - κ B activation, approved by the domestic drug administration in August 2011, for the treatment of rheumatoid arthritis < br / > developer: Xiansheng pharmaceutical, Tianjin Pharmaceutical Research Institute < br / > related patents: us19880255121, wo1994jp00585, jp20000386174, wo2004jp03057, cn2005115340, cn20101236615, cn20101236636, cn20101236651, cn2006114448, jp20070016185, cn2009128066, cn2009125605, wo2012jp71840, cn20131124889, wo2014jp69026, etc < br / > icotinib hydrocloride (cetinib hydrochloride) < br / > EGFR-TKI inhibitor, approved by the domestic drug regulatory department in June 2011, is suitable for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with sensitive gene mutation of EGFR < br / > developer: Beida pharmaceutical, beta < br / > related patents: wo2003us09593, wo2012cn87802, wo2013us55485, wo2014cn79491, wo2014cn79488, wo2014cn79484, us201414448070, wo2014cn88344, etc < br / > irexib < br / > selective epoxide hydrolase-2 inhibitor, approved by the domestic drug regulatory department in May 2011, is used to alleviate osteoarthritis
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