CDE drug review weekly report (2015.1.19-1.25)

1 Of the 40 drugs under examination and approval, there are 32 chemicals, 7 biological products for treatment and 1 biological product for prevention No Chinese medicine has entered the examination and approval process in this period Let's take a look at the chemicals reviewed this week: there are a lot of imported and re registered drugs entering the approval process this week, accounting for 16 For imported re registered drugs, there are 4: L-tryptophan, diquinium chloride lozenge (2), and isosorbide mononitrate tablets However, most of the imported drugs are nervous system drugs, anti-tumor drugs and immunomodulators For details, see Table 1: for the imported drugs that enter the approval process, Gramsci's trametinib and dabrafenib are both drugs used to treat melanoma, which were approved by FDA in May 2013 At present, only GlaxoSmithKline has applied for dabrafenib and dabrafenib in China This is the first time that these two drugs have entered the approval process In addition, recent studies have shown that darafinil combined with trimetazidine can improve the anti-tumor activity, so the two may be combined in the future The sustained-release tablet of hydromorphone hydrochloride is a kind of analgesic In 2010, the sustained-release tablet was listed in the United States At present, only the hydromorphone hydrochloride raw material and its injection of Yichang humanwell Pharmaceutical Co., Ltd are listed in China For hydromorphone hydrochloride sustained-release tablets, there is no listing, only two enterprises apply, namely Johnson & Johnson and Qinghai pharmaceutical factory Qinghai pharmaceutical factory has obtained clinical approval, while Johnson & Johnson's hydromorphone hydrochloride sustained-release tablets have just entered the approval stage For the domestic drugs entering the approval stage this week, most of them are new drugs, including 2 new drugs of 1.5 class, 7 new drugs of 3.1 class and 2 new drugs of 3.2 class The specific information is as follows: for the new drug of 1.5 class (new compound preparation), the sustained-release capsule of calodopa is composed of calodopa and levodopa according to 1:4 At present, only the controlled-release tablets of calodopa are imported into the market in China, but the advantages of the sustained-release capsules and the controlled-release tablets are still unknown until the clinical trial Meputanol hydrochloride is an analgesic drug originally developed by Wyeth The main dosage forms are injection, freeze-drying, capsule and tablet The approval history of this drug is very poor Tablets, injections and lyophilization have all been killed Therefore, caution should be taken when declaring this drug Injection is the most widely applied dosage form Before that, 5 have obtained clinical approval documents, and Sichuan Chuantou Pharmaceutical Biotechnology Co., Ltd was the first to obtain them Formoterol l-tartrate inhalation solution is exclusively declared by Beijing Wanquan sunshine Medical Technology Co., Ltd This product is used to treat chronic obstructive pulmonary disease Compared with formoterol, the dosage is reduced At present, there are 2 enterprises listed in daparin sodium injection, 4 enterprises apply for imitation, and Nanjing Jianyou Pharmaceutical Co., Ltd is the fastest 2 Only 21 drugs have been approved this week, including 11 chemical drugs, 6 traditional Chinese medicine and 4 biological products for treatment For 11 chemicals, most of them are in category 3.1 It seems that category 3.1 this week occupied most of the time of the leaders of the National Bureau Specific table 3: nevirapine sustained release tablets are not on the market in China at present This product is used to fight HIV infection and is also effective for children and adolescents The main dosage forms listed in China are tablets, capsules and suspensions For sustained-release tablets, bringer Ingelheim is the only enterprise to declare 3 Of the 32 drugs completed in this period, only half of them are chemical drugs, i.e 16, the other half are biological products, 6 biological products for treatment and 10 biological products for prevention For 16 chemicals, there is one imported re registered product: polysulfonate mucopolysaccharide cream, which is mainly used for treating skin diseases, inhibiting scars and eliminating scars At present, only one import company is producing this product in China, and three other document numbers have been cancelled Specific drug information is shown in Table 4: of the drugs that have been certified in this period, the most imported products are imported, and only topiramate tablets are declared for production For the generic drugs, the bioequivalence is to be approved, but there is no declaration of bioequivalence completed.