6-pound drug will be listed on the market as a new rare disease drug and over 1 billion injections

Highlights: 1 Another new drug for rare diseases will be put on the market; 2 The most advantageous antipsychotics will be developed in Japan; 310 million potential broad-spectrum antibacterial drugs will be approved in China for the first time; 4 More than 1 billion varieties of star injection generic drugs will be approved, or seize the opportunity to apply for consistency evaluation; 5 More than one month after the original research and marketing, Jiangxi Qingfeng heavyweight first imitation will be approved soon; 6 Anhui Baker biotherapy HIV-1 heavyweight first imitation will be approved; 7 The import application of melanoma combination drugs with sales volume of 5.894 billion won the acceptance of CDE; 8 In 2017, the world's second-largest selling cardiovascular drugs, another application of generic drugs with sales volume of $6.59 billion won the acceptance of CDE This week (January 4-11), there are 27 product regulations reported to update the processing status of production drugs, all of which show that they are "under approval" and will be put on the market soon; six of them are included in the priority review and are highly expected In addition, this week, there are 14 drug regulatory reports that have been accepted by CDE, mainly for imported drugs and generic drugs, and there is no new drug listing application Let's take a look at the specific situation! On January 4, the new dynamic new drug Shanxi Kangbao biological human prothrombin complex was reviewed and approved The application for listing of Shanxi Kangbao biological products [human prothrombin complex] showed that it was "under examination and approval" The drug was mainly used to treat congenital and acquired coagulation factor Ⅱ, Ⅶ, Ⅸ, Ⅹ deficiency (single or combined deficiency) On June 6, 2017, Shanxi Kangbao bio's application was included in the 19th batch of priority review on the basis of "listing of new drugs for rare diseases" At present, 6 domestic enterprises hold the production approval documents of the drug According to the sales database of pharmaceutical intelligent biological products, Hualan biological products is the best one among the six enterprises at present Since its marketing, the total sales volume has reached 3.38 million (bottles (pieces)), and the sales volume is 766 million yuan According to the overall sales situation of the drug in China, since 2008, the sales volume has increased in a straight line, reaching a peak in 2017, reaching 212 million yuan, slightly reduced in 2018, reaching 208 million yuan On January 4, the application for listing of gliclazide sustained-release capsule declared by Guangzhou bersera Pharmaceutical Co., Ltd showed that it was "under examination and approval" The indications of the drug were type 2 diabetes mellitus in adults who could not control blood glucose level only by diet therapy, exercise therapy and weight loss At present, only two domestic enterprises hold the production approval documents of the drug form In addition, gliclazide preparation mainly includes tablets, dispersible tablets, sustained-release tablets and capsules On January 4, the import application for [evolocumab injection] applied by Amgen bio showed that it was "under approval" The indications of the drug were hypercholesterolemia and mixed lipid abnormality Developed by Amgen, it was approved by the European Drug Administration (EMA) on July 17, 2015, and approved by the U.S Food and Drug Administration (FDA) on August 28, 2015, and sold by Amgen in the U.S and European markets under the trade name repatha The drug was approved for import by China on July 31, 2018 for the first time This application was included in the 29th batch of priority review on the basis of "obvious treatment advantages compared with existing treatment methods" On January 4, Sumitomo pharmaceutical's import application for lulaxione hydrochloride tablet showed that it was "under examination and approval" It is a new antipsychotic drug with dual effects, and it has a high affinity for both 5-HT2A receptor and dopamine D2 receptor It has a significant effect on both positive and negative symptoms of patients with psychosis Developed by Sumitomo pharmaceutical company of Japan, the drug was approved by FDA to be listed in the United States on October 28, 2010, under the trade name of latuda According to industry insiders, although there are some adverse reactions, it is currently the most advantageous one of all antipsychotic drugs This application is the first time to apply for import It will supplement the types of domestic psychotropic drugs and give patients more choices On January 7, the application for import of sitafloxacin tablets from the first three Co., Ltd showed that it was "under examination and approval" The drug belongs to the broad-spectrum quinolones Developed by first pharmaceutical Co., Ltd., it was listed in Japan in 2008 According to data, from 2011 to 2012, the sales volume of xishataxin in Japan increased from $7.9 million to $18.6 million, an increase of 135.4% According to the analysis of the insiders, the variety has the potential of 1 billion varieties At present, it has not been listed in China This time, the approved import will open up the market of the drug In the face of such potential drugs, domestic enterprises also have a layout At present, the most rapid progress is the application of three types of generic listing of chemical drugs applied by xinlitai, which is likely to become the first one Sichuan Huiyu docetaxel injection On January 4, Sichuan Huiyu's application for listing of [docetaxel injection] generic drug showed that it was "under approval" Docetaxel is a semi synthetic product of taxane, which has stronger activity than paclitaxel It is an anticancer drug acting on microtubules, which can promote the aggregation of microtubule proteins and inhibit the depolymerization of microtubules, thus inhibiting mitosis and leading to tumor cell death It was approved by FDA in 1996 for the treatment of advanced breast cancer, and then gradually expanded to non-small cell lung cancer, hormone refractory prostate cancer, gastric cancer, head and neck cancer, etc Docetaxel injection is a large variety with a sales volume of more than 1 billion in China At present, 20 enterprises hold the production approval documents of the drug, and 2 enterprises have applied for conformity assessment At present, none of them have passed the application This time, Sichuan Huiyu pharmaceutical has applied for new registration and classification, and it has been included in the 29th batch of priority review on the basis of "the same production line, listed in the European Union in 2013" If approved, The advantage will probably surpass Hengrui and Zhengda Tianqing On January 7, Shanghai xuantai Haimen Pharmaceutical Co., Ltd reported that the generic application of [metformin hydrochloride sustained-release tablets] in Shanghai xuantai Haimen Pharmaceutical Co., Ltd showed that it was "under approval" The indications of the drug were as follows: 1 For patients with type 2 diabetes who were not satisfied with simple diet control, especially those who were obese, they might also have the effect of reducing weight 2 It is effective for some patients with poor efficacy of sulfonylureas 3 It can be combined with sulfonylurea or insulin to improve blood glucose control At present, 44 domestic enterprises hold the production approval documents of the drug, and 10 enterprises have applied for conformity assessment, and 3 enterprises have passed This time, haixuantai Haimen Pharmaceutical Co., Ltd applied according to the new registration classification of 4 categories, and was included in the 29th batch of priority review for the reason of "production in the same production line, listed in the United States in 2018" If approved, it will compete with the enterprises passing the consistency evaluation in the market On January 7, the application for listing of the generic drug "lakosamide tablet" declared by Jiangxi Qingfeng pharmaceutical industry showed that it was "under approval" The drug was used for the combination treatment of partial seizures with or without secondary comprehensive seizures in adults and adolescents (16-18 years old) with epilepsy In 2017, the global sales reached 970 million euros The drug was developed by UCB In September 2008, lacosamide was first listed in the European Union as an adjuvant therapy for adult and adolescent patients (16-18 years old, with or without secondary systemic seizures), including film coated tablets, syrup and injection dosage forms It was approved by FDA in May 2009 On November 21, 2018, it was approved in China, becoming the first approved third-generation new antiepileptic drug in the Chinese market in 11 years More than one month later, the generic drugs declared by Jiangxi Qingfeng Pharmaceutical Co., Ltd are about to be approved, and this application is included in the 26th batch of priority review on the basis of "the applicant voluntarily withdraws and re declares the generic drug registration application (January 30, 2018) which is improved according to the standards consistent with the quality and efficacy of the original research drugs" Jiangxi Qingfeng may not only be listed for the first time, but also have quality assurance 。 On January 4, the generic application of lamivudine tenofovir tablets declared by Anhui Baker biological group showed that it was "under approval" The drug can be used together with other antiretroviral drugs to treat HIV-1 infection in adults over 18 years old Lamivudine and tenofovir dipivoxil, both of which belong to nucleotide antiretroviral inhibitors, have been approved by FDA to be on the market At present, it is not listed in China, only Anhui Baker bio has applied for the drug, and it is included in the 25th batch of priority review for the reason that "the applicant voluntarily withdraws and changes to the generic registration application which is improved according to the standard consistent with the quality and efficacy of the original research drug" Anhui Baker is likely to become the first listed company of the product, and it will also become the current domestic product The only listed company On January 7, the application for import of darafinil and trimetinib was accepted by CDE, Developed by GlaxoSmithKline (GSK), dalafeni was approved by FDA on May 29, 2013, and then approved by EMA on August 26, 2013 It is used to treat unresectable or metastatic melanoma with BRAF V600E or v600k mutation confirmed by FDA approval test Trimetazidine, developed by GlaxoSmithKline (GSK), was approved by the U.S Food and Drug Administration (FDA) on May 29, 2013, and then approved by the European Drug Administration (EMA) on June 30, 2014, under the name of mekinist As a single drug and in combination with darafinil, the drug is used to treat unresectable or metastatic melanoma with BRAF V600E or v600k mutation confirmed by FDA approval test Combination therapy is based on the need for sustained response rates, but has not been shown to improve related symptoms or overall survival The combined use of darafinil and trimetinib has a straight-line increase in sales in 2015, 2016 and 2017, reaching 873 million US dollars and 5.894 billion yuan in 2017 Shanghai huilun Jiangsu Pharmaceutical Co., Ltd rivaroxaban tablets on January 7, the generic application of [rivaroxaban tablets] declared by Shanghai huilun Jiangsu Pharmaceutical Co., Ltd was accepted by CDE Rivaroxaban is mainly a drug for the treatment of adult venous thrombosis, which is also an XA factor inhibitor Rivaroxaban was first listed in Canada on September 15, 2008 On July 1, 2011, it was approved by FDA to be listed in the United States In June 2009, rivaroxaban produced by Bayer entered China for the prevention of venous thrombosis in adults after elective total hip or total knee arthroplasty In May 2015, two new indications of rivaroxaban tablets (bairituo) were approved by CFDA, respectively, for the treatment and prevention of deep vein thrombosis and prevention of pulmonary embolism, and stroke prevention in patients with atrial fibrillation In 2017, xarelto's sales reached US $6.59 billion, an increase of 22.64% year-on-year, making it the world's second-largest selling cardiovascular drug At present, no imitated products have been listed in the domestic market, but many enterprises have made layout, including Sinopharm group, Harbin Pharmaceutical Group, Shuanglu pharmaceutical, Zhengda Tianqing, Sichuan Kelun, Chongqing Huabang, Chongqing shenghuaxi, etc.