Give priority to review and encourage the outbreak of children's drug research and development! 46 new drugs, 16 approved

Highlights recently, CDE released a new batch of publicity of drug registration applications to be included in the priority review process, which is the 33rd batch of list since December 2015 On December 21, 2015, CDE released the first batch of children's drug use registration application list that implemented priority review and approval, which aroused hot discussion in the industry At the national level, CDE has made full determination on the development of children's drugs, and also brought new hope to children's drug manufacturers Minenet has sorted out the list of 33 batches to be included in the priority review In the list of 33 batches, 63 products (calculated by "product name + application enterprise") are used for children's drugs, and 57 children's drugs are finally included successfully Figure 1: review status of children's drugs in the priority review list of 33 batches (unit: PCs.) (source: medchina drug review database 2.0 of minenet) As of October 22, 2018, 36 of the 57 children's drugs successfully included in the priority review have completed the review, of which 18 products have been approved (including production approval, import approval, clinical approval), and the review results of the remaining 18 products are none or others Among the 18 products approved successfully, 16 are new drugs and 2 are generic drugs none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; font-variant-numeric: normal; font-variant-east-asian: normal; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> 16 children's new drugs have been approved successfully: 7 new drugs have been put on the market, 9 new drugs have been clinically applied From the perspective of application items, 57 products have been included in the priority review procedure, 46 products have been applied for new drugs to be put on the market and new drugs have been clinically applied for, 33 products have completed the review and approval procedure, and 16 products have been approved for production, import and clinical application Table 1: 7 children's drugs approved for marketing (source: medchina drug review database 2.0 of minenet) 2 of the 7 children's drugs approved for marketing are domestic new drugs, all from Inner Mongolia Baiyi Pharmaceutical Co., Ltd Children's Multivitamin injection (13) and injection of children's Multivitamin (13) can fully supplement all essential vitamins for children The other five are imported new drugs, of which megestat capsule is used for the treatment of rare disease C-type Niemann peak disease; toluzumab injection is used for systemic juvenile idiopathic arthritis; ekuzumab injection is used for the treatment of rare disease adults and children paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome Table 2: 9 children's drugs approved for clinical use (source: medchina drug review database 2.0 of minenet) Among the 9 children's new drugs approved for clinical use, 7 are domestic new drugs, among which 3 are proprietary Chinese drugs, including Peitu Qingxin granules, Xiaoer Malong Zhike Pingchuan granules and Xiaoer Qingzhen oral liquid The other two are imported new drugs Exenatide injection is used to improve blood glucose control in patients with type 2 diabetes At present, the safety and effectiveness of exenatide injection, which has been put on the market, has not been determined in children The main group of patients approved for clinical research this time is children Faropenem is an atypical β - lactam antibiotic, which belongs to Penicilline derivatives The mechanism of action is to block the synthesis of bacterial cell wall and have strong binding with penicillin binding protein (PBP), so as to play a bactericidal role The approved clinical children's use of lopenan sodium dry syrup is the product's special dosage form for children none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; font-variant-numeric: normal; font-variant-east-asian: normal; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> two generic drugs have been approved for marketing: one is approved for production and one is approved for clinical application From the perspective of application items, among the 57 products included in the priority review process, there are 10 products applying for generic drugs to be listed and imitated for clinical application, and at present, there are 2 products that have completed the review and approval process Table 3: the main competitors of montelukast sodium granules in the market of approved children's generic drugs (source: mienei Med China drug review database 2.0) are MSD In 2017, the sales of the product in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) terminals exceeded 180 million yuan The product is suitable for the prevention and long-term treatment of asthma in children over 1 year old, including the prevention of daytime and nighttime asthma symptoms, the treatment of asthma patients sensitive to aspirin, the prevention of exercise-induced bronchoconstriction, and the alleviation of symptoms caused by allergic rhinitis (seasonal allergic rhinitis and perennial allergic rhinitis in children aged 2-5 years) At present, there are only tablets and capsules for aripiprazole in the domestic market, and there is no oral solution formulation Aripiprazole oral solution was jointly developed by Bristol Myers Squibb and Otsuka pharmaceutical and approved by FDA in 2005 In addition to new drugs and generic drugs, there is also a supplementary application, which is Sanofi's insulin glargine injection The product is used for children and is suitable for type 1 diabetes At present, the supplementary application has completed the review and approval process, and the result is not available none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; font-variant-numeric: normal; font-variant-east-asian: normal; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> 21 children's drugs are still on the way of evaluation: 8 new drugs to be listed are worthy of attention Up to now, 21 children's drugs are still in the process of evaluation and approval, including 13 new drugs on the market and clinical new drugs, 8 generic drugs on the market and clinical generic drugs Table 4:13 the situation of children 's new drugs under review (source: MED China drug evaluation database 2) of 8 children' s drugs applying for new drugs on the market, 4 of them are domestic products and all of them are biological products, including 13 valent pneumococcal polysaccharide conjugate vaccine, group A meningococcal polysaccharide conjugate vaccine, nasal spray freeze-dried influenza live vaccine and Recombinant Human Growth Hormone Injection Among them, the 13 valent pneumococcal polysaccharide conjugate vaccine on the market is only produced by Pfizer at present, and there is no enterprise to produce the nasal spray freeze-dried live attenuated influenza vaccine Table 5: situation of 8 children's generic drugs under review (source: medmedchina drug review database 2.0 on minenet) data source: CDE official website, minenet database