CDE drug review weekly report (2015.1.11-1.17)

There are 23 chemicals, 6 traditional Chinese medicines, 4 biological products for treatment, 2 biological products for prevention and 9 in vitro diagnostic reagents among the 44 drugs under approval The specific information of chemicals is as follows: Table 1 is the most in category 3.1 of the chemicals under review this week Except the enoxaparin sodium raw materials jointly declared with category 5, the rest are clinical applications The shortest one is atorvastatin strontium tablet, which was declared on March 31, 2012, and approved on January 15, 2015, lasting for 1020 days This product is strontium salt of atorvastatin, a lipid-lowering drug At present, only Hainan general Sanyo Pharmaceutical Co., Ltd has declared this product in China, while in foreign countries, this product is listed in Korea by Korea and America Pharmaceutical Co., Ltd., with four specifications of 10mg, 20mg, 40mg and 80mg At present, atorvastatin has four specifications Statine calcium only has the first three specifications in China I don't know what specifications Hainan GM applied for this time However, it took 1420 days to examine the laconamide tablets of Shandong innovative drug research and Development Co., Ltd., which was one year later than atorvastatin At present, this product has not been listed in China There are 11 manufacturers applying for this product Before Shandong innovation, three enterprises have obtained the clinical approval documents of this product, two of which are later than Shandong innovation It remains to be seen whether they can obtain the clinical approval documents successfully At present, this product has two kinds of application products in China: covertan hydrochloride injection (application from three enterprises) and covertan hydrochloride glucose injection (application from four enterprises) Beijing Furui Kangzheng Pharmaceutical Technology Research Institute is the first enterprise to be examined Xiao Bian went to the FDA to check At present, there are two specifications of konivertam hydrochloride on the market in the United States, namely 20mg of konivertam hydrochloride for injection and 20mg / 100ml of konivertam hydrochloride 5% glucose injection As for 20mg / 5ml of the injection, the prescription has been stopped The enoxaparin sodium + enoxaparin sodium for injection + enoxaparin sodium for injection declared by Chengdu Baiyu technology Pharmaceutical Co., Ltd in 3 + 5 + 6 can be described as the best of luck After 10 years, there is finally hope for production Besides blessing, we have to say that the products that can be produced in 10 years can stand the test of time Pharmaceutical companies should report and cherish Let's talk about imported products To be honest, I'm most afraid of code numbers or English declaration Because some statistics are easy to miss or you don't know that it has been declared at all, so every time you encounter this kind of drug, please note it down First, enmd-2076, developed by entremed, Inc., is an oral Aurora A / angiogenic kinase inhibitor with unique kinase selective properties and multiple mechanisms of action In addition to Aurora A kinase, enmd-2076 also has a distinct inhibitory property on angiogenesis At present, this product has completed a phase II clinical trial for ovarian cancer in the United States, while the phase II clinical trial for ovarian clear cell carcinoma and advanced / metastatic soft tissue sarcoma is being recruited Another phase II clinical trial for Sanyin breast cancer has been launched, which is still a long way from the market As for GlaxoSmithKline's pezopanil tablet, also known as pazopanil, is a new type of oral angiogenesis inhibitor that can interfere with the survival and growth of stubborn tumors It targets on the vascular endothelial growth factor receptor (VEGFR), and plays a role by inhibiting the new angiogenesis of tumor blood supply It is suitable for the treatment of advanced renal cell carcinoma (a type of renal cancer in which cancer cells are found in renal tubules), soft tissue sarcoma, epithelial ovarian cancer and non-small cell lung cancer At present, this product is not listed in China, and 5 domestic enterprises have applied for the clinical application of this product in category 3.1 Gsk573719 of GlaxoSmithKline (China) Investment Co., Ltd., also known as umeclidinium bromide, is a long-acting muscarinic receptor antagonist, which has been listed in the United States and used in patients with chronic obstructive pulmonary disease (COPD) This product is a kind of inhalant, and the compound preparation composed of another long-acting β 2 receptor agonist, vianterol, has also been listed in the United States Istaroxime for injection, declared by Zhaoke Pharmaceutical (Hefei) Co., Ltd (a wholly-owned subsidiary of Li's pharmaceutical factory Holding Co., Ltd.), is a new type of anti heart failure drug with dual effects of inhibiting Na + / K + - ATPase and activating sarcoplasmic reticulum calcium pump At present, a phase II clinical trial has been completed in the United States Among the 49 approved drugs, 45 chemicals, 1 Traditional Chinese medicine, 1 biological product for treatment, 1 biological product for prevention and 1 pharmaceutical auxiliary material Chemical medicine information is as follows: after the approval of Table 2, import and re registration of chemical medicine sofosbuvir tablets, Chinese name suofebuvir tablets or suofebuvir tablets, made headlines in 2014, and also made enough money for Gillette At present, in addition to the import of 6 domestic declaration of this product, the first one belongs to Beijing Kawei Biomedical Technology Co., Ltd., but it also has a long queue However, the import of sofosbuvir has been approved and the clinical opportunity will be available soon Table 3 new drugs approved and table 4 new drugs approved and generic drugs approved in China, new drugs and generic drugs have their own advantages The class 1.1 new drug of Guangzhou sepote Pharmaceutical Technology Co., Ltd has been approved, and has experienced a supplement during the period Now it has been approved successfully The sustained-release tablets of pioglitazone metformin of Jiangsu Haosen Pharmaceutical Co., Ltd have also been approved and approved for clinical use In addition, there are some peritoneal dialysate approved in this period, which will be supplemented once, waiting for conclusion Certificate preparation completed Of the 71 drugs, 44 chemicals, 10 traditional Chinese medicines, 15 biological products for treatment, and 2 biological products for prevention The information of chemicals is as follows: 5 chemicals are imported, involving 3 varieties, namely, the cycloserine raw materials and capsules of East Asia st Co., Ltd.; caglejing tablets (2 acceptance numbers) and terbinafine hydrochloride coating agent of Novartis Among them, caglejing tablet is approved for clinical use, and cycloserine capsule is an anti tuberculosis drug The conclusion is still unknown Table 5: after the completion of the preparation and certification of the domestic drug Yichang humanwell Pharmaceutical Co., Ltd., the application of propofol sodium for injection, a new drug of category 1.1, was filed in December 2013 After more than one year, it has also been approved for clinical use This drug has obtained a clinical approval in 2009, and may have been used in clinical bed This is the second time to obtain clinical application I hope it will continue to be successful Will the drug abandoned by Weicai and withdrawn by FDA rise up in China? In addition, class 1.1 new drug CM082 tablets of kananji Pharmaceutical Technology (Shanghai) Co., Ltd also obtained clinical approval For 6 kinds of generic drugs declared, Cefmetazole sodium for injection of Liaoning hisico Pharmaceutical Co., Ltd has been produced due to its bioequivalence test exemption This product was declared in September 2009 and lasted more than 5 years until it was approved.