[yaocajun] here you are! Mefalun has been approved for marketing in China. It is in urgent need of new drugs for rare diseases. There are also domestic monoclonal antibody PD-1 and 17 generic drugs

Highlights: 1 Domestic PD-1 monoclonal antibody will be approved soon; 2 Two kinds of rare diseases with heavy weight will be approved to be listed: mefalen hydrochloride and aimesuzumab; 3 The first generic drugs will appear; 3 The 1 billion varieties of generic drugs "issued" that Zhengda Tianqing, Haizheng and Hengrui are competing to declare; 4 The heavy generic drugs of another domestic enterprise will be listed, one of the top 10 best-selling drugs in the global cardiovascular system; 5 Hengrui tumor drug exclusive dosage form is about to be approved for the first time; 6 The consistency evaluation is reported to be successful, 5 drugs have been evaluated in the week, and 5 enterprise varieties are listed in 289 catalog This week (November 30 December 7), in the review and approval of drug status, there are 7 new drugs showing new trends, 12 imported drugs and 37 generic drugs See below for details Among the new dynamic new drugs reviewed and approved, there are 1 class 3 new drugs showing "issued", 2 drugs showing "approved pending certification", and 4 drugs showing "under approval", among which the PD-1 mAb treprizumab injection of Suzhou Zhonghe biomedical Co., Ltd is worthy of attention On December 3, the PD-1 mAb and trepril mAb injection of Suzhou Zhonghe trepril mAb showed that it was "under approval" As a hot target in the field of tumor, PD-1 has attracted much attention At present, the anti-PD-1 mAbs that have been listed in China include opdivo and keytruda And domestic enterprises are also scrambling for the first listing There are Xinda, Hengrui (Suzhou shengdia biological application) and Baiji Shenzhou that have applied for listing Now Junshi is likely to become the first listed company Among the imported drugs of this week, two drugs applying for clinical application have been approved for import because of the policy guidance, accelerating the speed of import registration of overseas listed new drugs in China, optimizing the review procedures for drugs for treatment of rare diseases and some drugs for prevention and treatment of serious life-threatening diseases, simplifying the listing requirements In addition, among the drugs reported for production, 1 drug is approved for import, 3 drugs are "issued", 2 drugs are "approved - to be prepared", and 4 drugs are "under approval" On November 30, rosizumab injection was approved for import to treat hemophilia A A patients with clotting factor Ⅷ inhibitor On January 30, 2018, aimesuzumab injection, as an urgently needed clinical product, was included in the 26th batch of the priority review procedure for the reason of "drugs for children, rare diseases" and accelerated the review and approval The drug, developed by Roche, is a recombinant humanized, bispecific monoclonal antibody, which can replace the cofactor activity of activated coagulation factor Ⅷ, promote the activation of F Ⅹ by F ⅸ a, and then lead to a significant increase in thrombin production, so as to achieve hemostasis in the bleeding sites of patients with F Ⅷ dysfunction or complete lack of F Ⅷ Yingchuangyuanda (Beijing) biological injection mephram hydrochloride November 30, yingchuangyuanda (Beijing) biological medicine technology declared that the injection mephram hydrochloride was approved for import for the treatment of multiple myeloma The drug is a rare disease drug in clinical shortage, and was included in the 19th batch of priority review on June 6, 2017 on the basis of "obvious treatment advantages compared with existing treatment methods" Among the generic drugs produced in this week's report, 12 drugs show "issued", 5 show "approved - to be certified", and 20 show "under approval" On December 5, cetrix acetate for injection in Shenzhen Hanyu Pharmaceutical Co., Ltd showed "delivered parts" Cetrix acetate was developed by Merck Serono, and was approved by the US Food and Drug Administration (FDA) for listing on August 11, 2000, under the trade name of cetrotide Cetrix acetate is a GnRH antagonist for injection The drug is suitable for preventing women from ovulating in advance under controlled ovarian stimulation, facilitating subsequent oocyte collection and assisted reproductive technology treatment At present, there are only imported drugs in China, only 2 domestic enterprises applying for listing of generic drugs, and Shenzhen Hanyu is about to obtain the first copy Praecoxib sodium for injection of Zhengda Tianqing, Haizheng and Hengrui On December 5, panaxib sodium for injection, a generic drug declared by Zhengda Tianqing, Haizheng and Hengrui, all showed "issued pieces" The drug was jointly developed by Pfizer and famasia company, with the trade name of dynastat In 2002, panaxib sodium for injection was first listed in Europe At present, it has been listed in at least 15 countries such as Germany, France and the United Kingdom The first imitation in China is Kelun pharmaceutical industry, and Qilu is the second approved enterprise According to the prediction of the insiders, the generic drug is expected to become a 1 billion level large variety, which is currently included in the 2017 national medical insurance category B now the three approvals are completed and the competition is intensified On December 3, risuvastatin calcium tablets of Changzhou pharmaceutical factory showed "approval completed - to be certified" Risuvastatin calcium was jointly developed by Shionogi and AZ It was approved to be listed by the US FDA in 2003, and began to enter the Chinese market in 2007, with the trade name of "determinable" As a new generation of statins and cholesterol lowering drugs, it is known as "super statins" because of its obvious lipid-lowering effect, and it is the heavyweight product of AstraZeneca Since 2010, the global market sales volume of "Keding" has been maintained at more than 5 billion US dollars After the patent expires, the generic drugs are listed, and the sales volume has decreased In 2017, Crestor's sales volume was US $2.66 billion, ranking third among the top 10 best-selling drugs for cardiovascular system in the world At present, 5 domestic enterprises hold the production approval documents of the drug, and all of them have applied for the conformity evaluation, and have passed 4 The drug market is huge, so there are many enterprises applying for listing, such as Hefei Yingtai Pharmaceutical Co., Ltd., Shijiazhuang No.4 Pharmaceutical Co., Ltd., Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd., Hefei Heyuan Pharmaceutical Co., Ltd., Beijing Wansheng Pharmaceutical Co., Ltd and Guangzhou Baiyunshan Pharmaceutical Group On June 5, 2018, the listing application of Changzhou pharmaceutical factory was included in the priority review on the basis of "production in the same production line, listing in the United States in 2016" Now it is about to be approved and will further carve up the market On December 3, the listing application of temozolomide for injection by Hengrui showed that it was "under examination and approval" The drug is a first-line drug for the treatment of malignant brain tumors It was first developed by Schering plough and listed in the United States in 1999 Temozolomide for injection was listed in the United States in 2009 At present, only two domestic enterprises have been approved to market the capsule, and there is no injection dosage form Jiangsu Hengrui is the only one that has applied for listing In the first week of December, the good news of consistency evaluation continued In the week, there were 5 drugs that had been evaluated, among which clindamycin hydrochloride and amlodipine besylate tablets were 289 catalogue varieties, and the number of amlodipine besylate tablets has reached 5 at present In addition, citalopram hydrobromide tablet of Sichuan Kelun was the first evaluated variety, while tenofovir dipivoxil fumarate of Fujian guangshengtang was the first evaluated variety of capsule For specific information about the drugs, please refer to the article: [1] in December, the first 5 enterprises in the 289 catalogue had reviewed the drugs [2] the exclusive dosage form of the first-line hepatitis B preferred drug passed the consistency evaluation, adding AIDS indications! 【3】 Good news in December! Kelun 2 drug passed the consistency evaluation, 289 catalog varieties, first-line antidepressants.. Review and approve a total of 12 newly accepted drugs this week, including 4 generic drugs applications, 4 imported drugs applications, and one application for in vitro diagnostic reagents The specific situation is as follows: data source: Yaozhi database statement: this point of view only represents the author and does not represent the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.