CDE drug review weekly report (March 23-29, 2015)

Among the 28 drugs approved to enter the approval process this week, 27 chemicals and 1 pharmaceutical excipient Among the 27 chemical drugs, there are no imported drugs, and 6 categories account for the majority, as follows: for the new drugs of category 3.1, I want to talk about the exclusive sivemeline hydrochloride from the applicant This product was developed by snow brand pharmaceutical company (Japan) and first launched in the United States in March 2000 This product is a cholinergic agonist binding to muscarinic receptor Like other muscarinic agonists, sufficient doses of muscarinic agonists can promote the secretion of exocrine glands (such as salivary glands and sweat glands), and increase the tension of smooth muscle of gastrointestinal tract and urethra The indications were dry mouth symptoms in patients with Sjogren's syndrome At present, Zhuhai Yibang Pharmaceutical Co., Ltd has exclusively applied for raw materials and two dosage forms Maybe the indications are too narrow, so there are not so many imitations The other one is memantine hydrochloride, which is widely used in the treatment of Alzheimer's disease Of course, there are many applicants, but only two are on the market, one is imported and the other is made in China (Zhuhai federal government) This week, memantine hydrochloride from both companies entered the approval stage, with one raw material and one preparation According to the small editor, these two should be 3 + 6 related reviews Yabao pharmaceutical provides preparations to medacom pharmaceutical At present, the product has obtained the clinical approval of bioequivalence There is still a long way to go before it goes on the market Come on Among the 22 drugs approved this week, 18 chemicals, 3 biological products for treatment, and 1 in vitro diagnostic reagent: among the drugs approved this week, the first class new drug sodium huaporphyrin and the imported drug e5501 have been introduced in the previous weekly report Let's talk about the rhinoceros extract tablet of Hunan Mingrui Pharmaceutical Co., Ltd This product has been monopolized by a Japanese import enterprise in China, and the application of domestic enterprises also ended in failure Xiaobian inquired about the diachronic declaration of this medicine, and found that there are both those declared according to traditional Chinese medicine and those declared according to chemical medicine, but no matter what kind of declaration, they were killed Let the exclusive come more fiercely! 3 Of the 46 drugs, 37 chemicals, 8 traditional Chinese medicines and 1 biological product for prevention The following mainly talks about the chemical information: most of the chemicals in this week are classified as 1.1, as shown in Table 1: the drug information has been introduced in detail in the previous weekly reports of 1.1 NEW drugs in this week, all of which have obtained the clinical approval documents In recent years, a large number of domestic enterprises have applied for class 1.1 drugs, and the main field of treatment is anti-tumor, which shows that the level of research and development of domestic enterprises is also gradually improving But what Xiaobian wants to say is that there are also 1.1 drugs on the market, but in terms of sales, they are not very optimistic The return on investment of new drugs in China is too low The class 3.1 drugs for clinical application have obtained the clinical approval documents, while the aminophenol tramadol tablets of Harbin Sanlian Pharmaceutical Co., Ltd have been applied for production, and entered the CDE review sequence in November 2010, and issued and supplemented once in January 2012 At present, the three in one review has been completed, and will be ready for listing It is composed of tramadol hydrochloride and paracetamol and is used for the treatment of moderate to severe acute pain At present, there are 6 domestic enterprises listed in aminophenol tramadol tablets and 1 enterprise listed in aminophenol tramadol capsules In addition, there are two kinds of enteral nutrition emulsions of fissenyuscapi in the drugs that have been proved, which should be approved for clinical use.