2012年1-10月，FDA批准的NMEs!

SYPHU_me

2012年获FDA批准的NMEs如下，包括药物的商品名、批准日期、活性成分以及适应症等。

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/default.htm

No.	Drug Name	Active Ingredient	Date	What it’s used for
28.	Fycompa	perampanel	10/22/12	To treat partial onset seizures in patients with epilepsy ages 12 years and older. Press Release
27.	Jetrea	ocriplasmin	10/18/12	To treat an eye condition called symptomatic vitreomacular adhesion (VMA). Press Release
26.	Stivarga	regorafenib	9/27/12	To treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic). Press Release
25.	Choline C 11 Injection	Choline C 11 Injection	9/12/12	A Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer. Press Release
24.	Aubagio	teriflunomide	9/12/12	For the treatment of adults with relapsing forms of multiple sclerosis (MS). Press Release
23.	Bosulif	bosutinib	9/4/12	To treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults. Press Release
22.	Xtandi	enzalutamide	8/31/12	To treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Press Release
21.	Linzess	linaclotide	8/30/12	To treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults. Press Release
20.	Neutroval	tbo-filgrastim	8/29/12	To reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils. Press Release
19.	Stribild	elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate	8/27/12	A once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection. Press Release
18.	Zaltrap	ziv-aflibercept	8/3/12	For use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer. Press Release
17.	Tudorza Pressair	aclidinium bromide	7/23/12	For the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Press Release
16.	Kyprolis	carfilzomib	7/20/12	To treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory. Press Release
15.	Prepopik	sodium picosulfate, magnesium oxide and citric acid	7/17/12	To help cleanse the colon in adults preparing for colonoscopy. Press Release
14.	Myrbetriq	mirabegron	6/28/12	To treat adults with overactive bladder. Press Release
13.	Belviq	lorcaserin hydrochloride	6/27/12	For chronic weight management. Press Release
12.	Perjeta	pertuzumab	6/8/12	To treat patients with HER2-positive late-stage (metastatic) breast cancer. Press Release
11.	Elelyso	taliglucerase alfa	5/1/12	For long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder Press Release
10.	Stendra	avanafil	4/27/12	To treat erectile dysfunction. Press Release
9.	Amyvid	Florbetapir F 18	4/6/12	Used as a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline.
8.	Omontys	peginesatide	3/27/12	To treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD). Press Release
7.	Surfaxin	lucinactant	3/6/12	For the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants. Press Release
6.	Zioptan	tafluprost	2/10/12	For reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Press Release
5.	Kalydeco	ivacaftor	1/31/12	For the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene. Press Release
4.	Erivedge	vismodegib	1/30/12	To treat adult patients with basal cell carcinoma, the most common type of skin cancer. Press Release
3.	Inlyta	axitinib	1/27/12	To treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer. Press Release
2.	Picato	ingenol mebutate	1/23/12	For the topical treatment of actinic keratosis.
1.	Voraxaze	glucarpidase	1/17/12	To treat patients with toxic levels of methotrexate in their blood due to kidney failure. Press Release

-从2002年以来，FDA平均每年批准NMEs24个，其中2002年最少17个，2004年高达36个，而今年有28个，与去年相当（PS:27）
在美国，申请新药流程大概是首先向FDA提交一份NDA，包括化学组成、生产工艺、动物和人体试验数据等，然后CDER审评，最后FDA panels批准是否获批。此过程，中国与其相似。

北京-构效

这个太有用了，尤其对国内搞模仿创新的公司

中科院-石头

另外，如果能找到上市药的专利过期时间总结，对于仿制药的选取应该会有较好的指引。要是谁有这方面资料共享下吧。

北京-构效

现在做仿创还是可以的，纯粹的仿制药个人感觉没有前途了

中科院-石头

赞同你的观点，我知道的仿制创新成功的有两个例子，一个是浙江贝达药业的Icotinib（如下图），另一个是郭宗儒的艾瑞昔布。Icotinib由原先阿斯利康的Erlotinib经过6,7位亲水链的环合，有效的规避专利的保护。其实，这里我之前也有个困惑的地方，这种me-too药物的研发（尤其是小改动）似乎对学术并没有多大贡献，仅仅是为了突破专利，降低风险和经济利益。这也许是面对国内药物研发现状所选择的一条妥协道路，正如郭宗儒所提倡的“仿制创新”概念一样。反观国外一些大学和公司的药物研发，往往是在庞大的生物医学知识基础下，或筛选，或设计，得到全新化合物的药物，反过来利用这些化合物促进生命科学的研究和治疗疾病。扯远一点说，前者是技术，后者是科学。

北京-构效

浙江贝达药业的Icotinib其实不是他们研发的，是老板所在国外公司筛选化合物中的一个，只是性质比另外一个药差就没有申报专利，他们运气特别好。
全新药物研发涉及到的领域太广，中国目前没有这样的综合实力。做企业首先要生存，才能有力量研发，仿创算是一种既适合国内研发实力又能给企业一些生存希望的平衡模式。

SYPHU_me

北京-构效 发表于 2012-10-26 13:28

                               
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浙江贝达药业的Icotinib其实不是他们研发的，是老板所在国外公司筛选化合物中的一个，只是性质比另外一个药 ...

十二五之后国家重视了有中国特色的新药研发，期望能有不错的未来。。。。。。

blue_cat

但是国家还是很鼓励仿制药的，特别是能产业化的，之前发改委还搞了个通用名药物的专项，每个项目都上千万的资助额。