CDE priority review 12th batch list analysis: Novartis anti-heart failure drug LCZ696 finalist is the biggest highlight
December 23, 2016
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)]; On December 2nd, the CDE announced the twelfth batch of publications to be included in the application for registration of drugs for priority review procedures. A total of 32 acceptance numbers were included in the list.
Foreign countries have been listed on the same time to apply for domestically listed generic drugs <br> In this list of acceptance numbers, the reason for the selection is “foreign listed products that have been listed on the domestic market for simultaneous listingâ€, respectively, from 3 products involving 9 acceptance numbers, for Jiangsu Huayi's Fluorine [18F] Deoxyglucose Injection, Montelukast Sodium from Guangzhou Anxin, Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets from Shanghai Ambition Pharmaceuticals, and Valsartan from Zhejiang Huahai sheet. Once approved, the above products mean they can get the title of “consistency evaluationâ€.
The Hada Data V3.2 found that there were 4 companies in the first batch of self-examination, namely the July 24, 2015 self-examination list, which were Xindong Biotech (acceptance numbers JXHS1100042 and JXHS1100043). ), Yangzijiang Pharmaceutical Group Nanjing Hailing Pharmaceutical (acceptance number CYHS1190015), Beijing Wansheng Pharmaceutical (acceptance number CYHS1190034) and Beijing Hanmei (acceptance number CYHS1390027 and CYHS1390028). The acceptance number of Beijing Wansheng Pharmaceutical Co., Ltd. was withdrawn in the 21st Announcement of 2016, and the acceptance number of Beijing Hanmei was withdrawn in No. 264 of 2015 and No. 287 of 2015 respectively. Shanghai Ambushi Pharmaceutical's montelukast sodium chewable tablets are jointly reported with Hangzhou Minsheng Binjiang Pharmaceutical. It is expected that this priority review is also a human bioequivalence test. Currently listed companies with montelukast sodium chewable tablets and montelukast sodium tablets include Lunan Beit Pharmaceutical and Sichuan Daxie Pharmaceuticals, both of which need to accelerate the declaration of “consistency evaluationâ€.
The declaration of Zhejiang Huahai Pharmaceutical's 缬沙å¦ç‰‡ can be described as twists and turns. After entering the first self-inspection list, it was withdrawn in the announcement No. 255 of 2015. Although it has been approved by the FDA and listed in the US, this time it has received a priority review. The human bioequivalence test is still to be redone. At present, only one domestic manufacturer of Changzhou four drugs is listed on the valsartan tablets, and the capsule is more competitive.
First imitation variety <br> Moxifloxacin hydrochloride (acceptance number CXHS1400150) of Beijing Wansheng Pharmaceutical Co., Ltd. was selected in the first batch of self-examination lists and selected for the twelfth batch of priority review list on the grounds of “first imitation varietyâ€. Moxifloxacin hydrochloride tablets (acceptance number CYHS1490056), which is also in the on-site verification plan announcement (No. 8) of the drug clinical trial data, the corresponding sample hospital market size is 150 million yuan. The variety of Jiangsu Tianyishi Pharmaceutical and Chongqing Huabang Pharmaceutical, which were also in the first batch of self-examination, has been announced to be withdrawn. In addition, Peking University's moxifloxacin hydrochloride tablets (CYHS1690001) entered the fourth self-inspection, the self-inspection list on November 4, 2016. It is expected that moxifloxacin hydrochloride tablets will enter the era of generic drug competition.
AIDS drugs <br> CTTQ fumarate ester tenofovir disoproxil sheet (admissibility CYHS1600082) to "anti-AIDS drugs" by entering priority reviews. Zhengda Tianqing also entered the first self-check list and was withdrawn in the 21st Announcement 2016. The same companies have Zhuhai Federal Pharmaceutical Zhongshan Branch, Anhui Becker and Zhejiang Nanyang Pharmaceutical.
Chengdu Beite Pharmaceutical Co., Ltd., which was on the first self-check list, has undergone the on-site verification plan for the No. 1 drug clinical trial data in 2016. It is reported that it has been approved for production. Chengdu Bite's clinical indications for 2013 include chronic hepatitis B (for adult patients and children over 12 years old) and HIV-1 infection (combined with other antiretroviral drugs for adult patients and children 2 years of age and older) patient). If Chengdu Bite has approved the indications for anti-AIDS drugs, the reason for the priority review of tenofovir disoproxil fumarate tablets is doubtful.
The re-declared Anhui Baker Biological entered the third batch of self-inspection, which was the self-inspection list on September 1, 2016. At the same time, Qilu Pharmaceutical was also included in the third batch of self-inspection. The two companies also faced the No. 8 drug respectively. On-site verification plan for clinical trial data and on-site verification plan for drug clinical trial data No. 7.
Since 2015, there have been 5 products related to the priority of review and approval of anti-AIDS drugs. In the twelfth batch of priority review lists, in addition to tenofovir disoproxil fumarate tablets, there are also Jiangsu Aidi’s declarations. ACC007 API. ACC007 is a novel non-nucleoside reverse transcriptase inhibitor for the treatment of HIV. It is reported that in Korea, the first phase of the first phase of human volunteers has completed the first dose of SAD and multiple doses. Ascending MAD clinical research.
Rare disease <br> Beijing Nosland and Bayer HealthCare Ltd. Recombinant human factor VIII for injection is given a priority review for “rare disease†reasons, and is the third product that is expected to be reviewed for priority due to rare diseases. The indication is type A hemophilia.
There are 9 products with more clinical advantages due to more clinical advantages, and 12 in the twelfth batch, which are Pfizer's apixaban tablets, Beijing Novartis's Shakuba Qusarsar Sodium tablets, Bayer's Leocitin tablets and Xi'an Janssen's Ibubini capsules are all declared for production.
Domestic Apixaban tablets are listed by Bristol-Myers Squibb, which was jointly developed by Bristol-Myers Squibb and Pfizer, and the domestic sales rights were recently handed over to Pfizer. Pfizer's report is expected to increase the reduction of deep vein blood in the legs after initial treatment, based on the prevention of VTE in adult patients undergoing elective hip or knee replacement and the prevention of stroke and systemic embolism in NVAF adult patients. Indications for clots (ie, deep vein thrombosis) and recurrence of pulmonary embolism.
Shakuba Qusartan sodium tablets and Leocitin tablets entered the third self-inspection list. Shakuba trosartan sodium tablets, LCZ696, is a combination of angiotensin II inhibitor valsartan and enkephalinase inhibitor AHU-377. The indication is to reduce heart disease death and heart disease in patients with chronic heart failure. The risk of hospitalization. Leocitus tablets were approved by the FDA for the treatment of pulmonary hypertension on October 8, 2013. The indication for ibbutinib capsules is to treat newly diagnosed, relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Children's Medicine <br> A total of 14 products have received a priority review for children's medicines. The 12th batch of children's medicines that have received priority review is the oral five-valent reassortment rotavirus live vaccine (Vero cells) developed by Merck. In the past six months, 2 imported vaccines have been approved. In November 2016, Pfizer's 13-valent pneumococcal conjugate vaccine was approved, mainly for children. GlaxoSmithKline's human papillomavirus vaccination was approved in July 2016.
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