[yaocajun] 198 new drugs "approved - to be certified" are all traditional Chinese medicine; a number of heavyweight first-time imitations of competitive drugs have been launched in an explosive rush, and the first imitations in Beijing, Zhejiang Province

New drugs of Yaowen 01 in China: 198 traditional Chinese medicines have been approved and potential chemical and biological drugs have been applied for listing Last week (August 18-24), according to the data of pharmaceutical intelligence, in the production of new drugs, one biological drug and two chemical drugs have been undertaken, and 199 new drugs have been accepted and updated (attached with 199 drug lists), 198 of which show "approval completed pending certification", and one shows "under approval" The new drugs are olanzapine oral instant film, a new class 2.2 drug from Haosen, Jiangsu Province, and hepatitis B human immunoglobulin, a biological product for the treatment of Da'an pharmaceutical, Hebei Province Olanzapine was developed by EliLilly, approved by the European Drug Administration (EMA) on September 27, 1996, and then approved by the U.S Food and Drug Administration (FDA) on September 30, 1996 It is sold in various places by Lilly, and its product name is Zyprexa Olanzapine is an antagonist of dopamine and serotonin 5ht2 The drug is suitable for schizophrenia, moderate to severe manic episode, bipolar disorder At present, in addition to imports, the main domestic dosage forms are tablets Changzhou Huasheng pharmaceutical and Jiangsu Haosen have approval documents At present, the oral instant film dosage form is more and more recognized In addition, the tablet is not so convenient for many cases of depression medication I believe that the marketing attempt of the new dosage form of hausen will increase its chips in this market Human immunoglobulin of hepatitis B is mainly used for the prevention of hepatitis B According to the pharmaceutical intelligence data, among the top 50 annual sales of vaccine products, hepatitis B human immunoglobulin ranks 27th Since 2008, its total sales volume has reached 4.968 billion yuan At present, there are 24 enterprises with production approval documents in China, and Hebei Da'an Pharmaceutical Co., Ltd also has 3 specifications of approval documents before, but the market sales share is not much According to the pharmaceutical intelligence data, the best seller is Hualan biotechnology Cheng Co., Ltd., with sales of 1.09bn Among the 199 new traditional Chinese medicine drugs reported to be in the new processing state this week, 181 are of class 8 new drugs, and the rest are of class 9 new drugs In addition, from the date of undertaking, we can see that the drugs for this status update were undertaken more than ten years ago, mainly in 2005 and 2006, which can be said to be a long-term solution to the backlog of TCM approvals 02 generic situation: two first generic drugs will be approved soon, and several first generic competitive products will be undertaken This week, a total of 11 generic drugs will be declared for listing and undertaken; 10 generic drugs will be updated, including 8 generic drugs showing "approved - to be certified" and 2 generic drugs showing "under approval" 1 Report on the new undertaking of production of generic drugs Among the newly undertaken generic drugs, exenatide injection applied by Qinghai ChenFei Pharmaceutical Co., Ltd., apixaban tablet of Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd., weiglijing tablet of Shandong Yuxin Pharmaceutical Co., Ltd., posaconazole injection of Jiangsu aosaikang Pharmaceutical Co., Ltd and xigliptin phosphate tablet of Ouyi Pharmaceutical Co., Ltd are all the first generic drugs to compete; gefitinib tablet of Yangzijiang Pharmaceutical Co., Ltd is a product with better market prospect; Ouyi tablet of Shiyao Pharmaceutical Co., Ltd Irinotecan liposome is the first one to be listed Exenatide injection exenatide injection is a type 2 diabetes drug At present, there are no generic drugs on the market in China There are six enterprises applying for listing The four generic drugs applying for chemical drugs are Wuxi Hebang biological and Qinghai Chenfei pharmaceutical The application serial number of Hebang pharmaceutical is currently before Qinghai Chenfei, the first generic drugs may be Hualuo Hebang pharmaceutical As a heavy-duty target clotting factor Xa anticoagulant, apixaban, with a global sales volume of US $7.395 billion in 2017, ranked first in the global anticoagulants in 2017 Many domestic enterprises have carried out the first imitation competition, including Sichuan Kelun, Jiangxi Qingfeng, Zhengda Tianqing, Jiangsu Haosen and other enterprises Viagretin tablets developed by Novartis were approved by China food and Drug Administration (CFDA) on August 15, 2011, and sold in Europe by Novartis under the trade name galvus As a selective, competitive and reversible dipeptidyl peptidase (DPP-4) inhibitor, visgliptin is used to reduce hyperglycemia in type 2 diabetes mellitus At present, there are no generic drugs listed in China, and there are many competitive enterprises, including Qilu, Luoxin, Jiangsu Haosen, Beijing Taide and other enterprises Posaconazole injection, which was jointly developed by MSD, was approved by the US Food and Drug Administration (FDA) on September 15, 2006 and marketed by MSD The product name is noxafil The drug is suitable for the treatment of refractory fungal infections (such as invasive Aspergillus, Fusarium, yeast, Mycobacterium, coccidiosis) It is the first time for the treatment of thrush and the prevention of serious fungal infections At present, there are only imported drugs in China, and only Chengdu shengnuo biopharmaceutical and Jiangsu aosaikang Pharmaceutical Co., Ltd are in the production of generic drug report The listing serial number of shengnuo biopharmaceutical is located before aosaikang Cigliptin phosphate tablets were approved for marketing in 2007 for the treatment of type 2 diabetes At present, there are only imported drugs in China, and the competition of generic drug applications is fierce The listing applications of many enterprises are under review and approval Gefitinib, developed by AstraZeneca (AZ), was approved by the US Food and Drug Administration (FDA) on May 5, 2003 and sold by AstraZeneca under the name of IRESSA Gefitinib is the first EGFR tyrosine kinase selective inhibitor It is suitable for the continuous treatment of platinum and docetaxel chemotherapy failure of local advanced or metastatic non-small cell lung cancer At present, Qilu has won the first imitation in 2016, passed the consistency evaluation, and entered the catalogue of Chinese listed drugs There are many other enterprises reporting production The next listed enterprises will have the opportunity to share this market share Irinotecan liposome injection irinotecan liposome injection for the treatment of advanced pancreatic cancer On August 22, the listing application of Ouyi, a stone drug, was undertaken At present, 10 domestic enterprises have the production approval documents of irinotecan hydrochloride for injection, but there are still no liposome injection There are many enterprises that have been approved for clinical application, including Jiangsu Hengrui, Qilu, Jiangsu aosaikang, Nanjing LVYE and Sichuan Kelun In addition, irinotecan hydrochloride liposome injection of lithopone has also been approved by the FDA of the United States to conduct clinical trials Among the drugs in the new status of production of generic drugs in the new status of generic drugs, it should be noted that both micuronium chloride injection of Guangdong Jiabo pharmaceutical and pramipexole hydrochloride tablets of Zhejiang Jingxin are the first generic applications Micuronium chloride injection micuronium chloride injection was approved by FDA in 1992 The indication was non depolarizing muscle relaxant At present, there is no generic drug listed in China, and Guangdong Jiabo Pharmaceutical Co., Ltd will be the first generic enterprise if approved Pramipexole hydrochloride tablets, approved for marketing in 1997, are used to treat the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa At present, there are only imports in China On August 24, Zhejiang Jingxin announced that it has received the approval, obtained the approval of CDE and won the first imitation listing 03 situation of imported drugs: the approval of olapari, the world's first PARP inhibitor, has been completed, or the gap in the field of targeted treatment of ovarian cancer in China has been filled for nearly 30 years In terms of imported drugs, this week two drugs showed "approval completed - to be certified" It is worth noting that AstraZeneca's olapalin tablet is the world's first PARP inhibitor, which was approved by the FDA as early as December 2014 for the four line treatment of advanced BRCA + ovarian cancer In 2017, it was approved by the FDA for the treatment of adult ovarian epithelial cancer and fallopian tube cancer after response to platinum drugs Second line maintenance therapy for patients with primary peritoneal cancer This listing application in China was undertaken in December 2017, and then entered the priority review sequence If this application is approved, it also means that it may become the first PARP inhibitor listed in China, filling the gap in the field of targeted treatment of ovarian cancer in China for nearly 30 years Attachment: list of 199 traditional Chinese medicine new drugs source: intelligence data