CDE drug review weekly report (June 14, 2015 to June 27, 2015)

Introduction: 1 Hangzhou Zede Pharmaceutical Technology Co., Ltd applied for cn128 and tablets of class 1 new drug; 2 Jiangsu Wanbang Biochemical Medicine Co., Ltd was the first one in China to apply for dacaravir hydrochloride tablets; 3 Sichuan Guorui Pharmaceutical Co., Ltd was the second one in China to apply for ruijianuosheng injection, a cardiovascular contrast agent; 4 Sichuan Kelun Pharmaceutical Co., Ltd is the first company in China to apply for dexmedetomidine hydrochloride and sodium chloride injection; 5 Sanofi is the first company in China to apply for the biological product sar231893 for the treatment of asthma; 6 Pfizer is the first company in China to apply for the injection solution of tanezumab for the analgesic biological product; 7 Shanghai Rixin Biological Technology Co., Ltd is the first company in China to apply for the injection of dexmedetomidine hydrochloride and sodium chloride; 5 Sanofi is the first company to apply for the injection of sar231893 for the treatment of asthma; 8 Adefovir dipivoxil dispersible tablets of Hunan Fangsheng Pharmaceutical Co., Ltd are undergoing three in one review and will be approved for production; 9 Compound sodium acetate ringer injection of class 3.2 drug of Sichuan Kelun Pharmaceutical Co., Ltd has completed three in one review; 10 Diquafosol eye drops of Shentian Pharmaceutical Co., Ltd have been approved for clinical use; 11 Tianbian Mitsubishi Pharmaceutical Co., Ltd mp-214 tablet has been approved for clinical use; 12 Anhui Baker biopharmaceutical Co., Ltd class 3.2 new drug lamivudine tenofovir tablet has been approved for clinical use; in the review In the past two weeks (June 14, 2015 to June 27, 2015), 173 drugs (according to the acceptance number) have entered the review status, including 152 chemicals, 3 traditional Chinese medicines, 10 biological products for treatment and 8 pharmaceutical excipients The key points are as follows: 1 Cn128 tablets: This product is a class 1.1 chemical drug, which was declared by Hangzhou Zede Pharmaceutical Technology Co., Ltd without any information, even the company did not find any information You can tell Xiaobian if you have a known partner 2 Dakaravir hydrochloride tablets: developed by Bristol Myers Squibb, English name is daclatasvir, July 4, 2014, approved by the European Union, trade name is daklinza It is mainly used in combination with other drugs for the treatment of all adult patients with chronic hepatitis C (HCV) of genotype 1, 2, 3 and 4 Daklnza is a powerful pan genotype NS5A replication complex inhibitor In clinical trials, when combined with Gilead hepatitis C star drug sovaldi (daklnza + sovaldi), it achieved 100% cure rate, including patients with advanced liver disease, genotype 3 HCV and previous failure of protease inhibitor treatment Group At present, Jiangsu Wanbang Biochemical Medicine Co., Ltd is the first class 3 + 3 declaration in China, which is a subsidiary of Shanghai Fosun Pharmaceutical Co., Ltd 3 Regadenson injection: also known as regadenson, it is a selective adenosine receptor agonist, which can relax the coronary artery The drug is used for radionuclide myocardial perfusion imaging in patients who are unable to undergo exercise stress testing In October 2013, FDA listed this product on its latest quarterly monitoring product list, with potential signs of myocardial infarction (MI) and death risk At present, there are two domestic applications 4 Dexmedetomidine hydrochloride and sodium chloride injection: dexmedetomidine hydrochloride injection is mainly used for sedation during tracheal intubation and mechanical ventilation in patients undergoing general anesthesia Before administration, the product must be diluted with 0.9% sodium chloride solution to the concentration of 4G / ml, and then be injected slowly for more than 10 minutes At present, there are 4 listed companies in China, while the large volume injection has not been listed so far, and Sichuan Kelun is the first company to declare As early as June 2014, Hunan Kelun Pharmaceutical Co., Ltd., a subsidiary of Kelun Pharmaceutical Co., Ltd., declared dexmedetomidine hydrochloride injection and large volume injection, but it is speculated that it has been withdrawn At present, it is urgent to declare It can be seen that Kelun pharmaceutical wants to catch up with the big and the small 5 Sar231893 injection: developed by regenerant / Sanofi, this product is a complete human monoclonal antibody of interleukin-4 receptor alpha subunit, English name is duplimab, mainly for the treatment of moderate and severe persistent asthma, eczema and nasal polyps with increased eosinophil level This product is not on the market at present, Sanofi has applied for clinical application for the first time in China Tanezumab injection: developed by Pfizer, it is a humanized monoclonal antibody targeting nerve growth factor (NGF) Nerve growth factor (NGF) is an important protein in the process of regeneration after nerve injury, which is involved in the survival and differentiation of sensory and sympathetic neurons There is evidence that it plays a role in the pathogenesis of chronic pain in knee osteoarthritis This product was previously tested in the clinical trials of bone pain, and was stopped by FDA due to safety issues In 2013, it signed a joint development agreement with Lilly However, at present, clinical trials of this product are not planned In the past two weeks (2015.6.14-2015.6.27), 30 drugs (calculated according to the acceptance number, the same below) entered the approval status, including 23 chemicals, 1 Traditional Chinese medicine, 5 biological products for treatment and 1 biological product for prevention Key drugs: 1 Phenylphosphothiamine tablets: phenylphosphothiamine is a fat soluble derivative of vitamin B1, which improves the low bioavailability of water-soluble vitamin B1, improves the concentration of thiamine in blood and tissues, and thus improves the efficacy Before that, it was mainly used to prevent side effects and complications of diabetes, and it can effectively treat and prevent diabetic retinopathy Shanghai Rixin applied for the new unlisted indications at home and abroad, which was undertaken by CDE in July 2013 and supplemented once in June 2014 At present, it has successfully obtained the clinical approval 2 Adefovir diphosphate dispersible tablets: adefovir diphosphate is a acyclic nucleoside analogue of adenosine monophosphate, which is phosphorylated into an active metabolite, adefovir diphosphate, under the action of cytokinase, and is mainly used for the treatment of chronic hepatitis B infection At present, there are two kinds of dosage forms in China, ordinary tablet and capsule At present, the dispersive tablets declared by Fangsheng pharmaceutical have completed the three in one review and are undergoing the three in one review, and will be mass produced soon 3 Compound sodium acetate ringer injection: This product is a compound preparation of sodium acetate ringer injection, no specific ingredients were found Sodium acetate ringer injection is a kind of body fluid supplement It is used to supplement the circulating blood volume and tissue fluid to reduce the extracellular fluid and metabolize acidosis At present, there is only one product on the market in China Kelun pharmaceutical declared compound sodium acetate ringer injection on August 3.2, 2012 At present, it has completed the three in one review and will be approved soon 4 Diquafosol eye drops: This product is developed by towering Pharmaceutical Co., Ltd and listed in Japan in 2010 It is the first P2Y2 receptor agonist eye drops approved for market in the world It is mainly used to treat dry eye In 2012, Shengtian pharmaceutical first applied for the clinical application of this product in China, and has been approved for clinical application so far In addition, at present, there are 2 domestic enterprises applying for the clinical application of class 3.1 See attached Fig 1 for the drugs approved in the approval 101 drugs have been approved in the past two weeks, including 92 chemical drugs, 7 traditional Chinese medicines, 1 biological product for treatment, and 1 pharmaceutical excipient Key drugs: 1 Mp-214 tablet: the English name of this product is cariprazine, developed by Gedeon Richter, which is used to treat schizophrenia At present, it is in the registration stage in the United States, which is jointly declared by atvis and Gedeon Richter This product has been rejected by FDA I wonder if it can be approved this time In China, this product is declared by taganabe Mitsubishi Pharmaceutical Co., Ltd and has been approved for clinical use See attached Fig 2 for the approved clinical drugs after approval In the past two weeks, 122 drugs were approved, including 89 chemical drugs, 21 traditional Chinese medicine, 6 biological products for treatment and 6 biological products for prevention Lamivudine tenofovir tablets: This product is a compound of two antiviral drugs, mainly used for the treatment of severe AIDS combined with chronic viral hepatitis B Lamivudine and tenofovir dipivoxil are both nucleotide antiretroviral inhibitors, which can reduce the resistance of the virus when used together This product has been approved by FDA for marketing At present, there is only one clinical application in China, which has been approved so far See attached Fig 3 for approved clinical drugs after approval Attached: