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FDA approved 13 new drug reviews approved from January to June 2013
Release time: 2013-09-03 & nbsp & nbsp & nbsp Source: Anonymous

    Recently,Famous journals in the field of drug research and development、Nature Review Drug Discovery published a very short news,Briefly summarized 13 new medicines approved by the US FDA from January to June this year,The names of these new drugs、For manufacturers and adaptive symptoms, see Table below below。


 
  

    The number of 13 new drug approved by the US FDA from January to June this year is basically equivalent to the same period last year,FDA approved a total of 39 new medicines in 2012,Creating a new high for the past 15 years,It is estimated that this year is another harvest year for the pharmaceutical industry。
 
These 13 new drugs are mainly developed by 11 companies,Among them, look at the number of new drugs approved for,GlaxoSmot (GSK) is the biggest winner,There are three new drugs approved,The remaining 10 companies have only one new drug approval。These three new medicines of GSK,The indications of two medicines are basically the same,All are for melanoma。Just in the recent,That is, early August this year,GSK's fourth new drug this year (indication: AIDS) is also approved by FDA。So,Although GSK seems to be unfavorable in China this year,Scandal stake betting appof academic stake online sports bettingfraud and bribery in succession,But the good news of the above four new drugs seems to be diluted with these negative news。
 
It is worth mentioning that it is,Even if GSK is in a Chinese scandal,Never give up the Chinese market,Recently GSK decided to seek Chinese partners to jointly develop new vaccines。The research and development of new vaccines is my country's shortcomings,But the long item of GSK,I believe that the Chinese cooperative company in the GSK phase will benefit a lot,I hope that related companies in our country can also get leapfrog development from the cooperation with NB multinational pharmaceutical companies such as GSK。
 
Among the 13 new medicines approved,Some are still valuable,The first is the Ado-Trastuzumabemtansine (Inn in the United States (INN in the United States,Trademark name kadcyla)。
 
This medicine is based on the so-called ADC technology (Antibody-Drug Conjugates,Antibody Puppet Drug)。Because of this relatively new technology importance,This article focuses on introducing、Comments。ADC drugs are made of antibodies (or antibody fragments) and chemicals,The advantages of both biopharmaceuticals and chemicals,It is a new anti -tumor drug designed by the unique targeted properties of antibodies and the highly cytotoxic drugs,Able to accurately enrich the drugs in the tumor tissue,Therefore, there is basically no toxicity for normal cells while killing tumor cells。If general chemical drugs are scattered bullets that are commonly killed by normal cells and pathogenic cells (including cancer cells),and ADC -class medicines are precise guided missiles,So ADC medicine is also called & ldquo; biological missile & rdquo;。

At present, there are at least 30 candidates for candidates at least 30 ADC categories in the clinical experimental stage,Its indications are all different types of cancer (including physical tumors such as breast cancer and prostate cancer),Among them, a candidate new drug of Pfizer (formerly Wyeth) has been conducting Stake Sports Bettingphase stake online sports bettingIII clinical experiments,It is expected to end all clinical experiments at the end of next year。
 
Roche's new ADC new drug (ie KADCYLA) is the third ADC -based new drug approved by FDA,The first ADC new drug is Pfizer/Wyeth's Gemtuzumab ozogamicin,Approved in 2001,In June 2010, the right to approval was recovered by the FDA for some reason,So this medicine now,No sales in the market,So this medicine,Strictly speaking,I have been approved。
 
The second ADC new drug is Pentuximab Vedotin (Seattle Genesis Technology Company) at Seattle Genetics。Roche's Kadcyla will be a monoclonal antibody trastuzumab (that is, the famous HERCEPTIN,Herceptin) connected to the drug (ie DM1),Trastuzumab antibody itself is to inhibit the growth of tumor cells by targeting a targeted binding to HER2/neu receptor,and chemical small molecular medicine MERTANSINE enters cells,So as to kill cancer cells by combining microthelium protein,So,Kadcyla is to kill the cancer cells through the combination of biopharmaceuticals and chemical drugs,Because HER2 protein is only expressed in tumor cells,So the medicine only works for tumor cells,Basically there is basically no effect on normal cells。

Generally speaking, ADC -type medicines are due to the above advantages,Its toxic side effects are significantly lower than general chemicals,but,As the old words in our country & ldquo; ten medicines nine poisons & rdquo;,ADC medicines are not & ldquo; Shen medicine & rdquo;,There will still be thrombocytosis、Side effects such as neutral white blood cells and other side effects。
 
Another highlight new drug is Mipomersen Sodium (product name Kynamro),This medicine is an antisonation platform technology based on targeted MRNA,This is the second -generation antisonation oligonucleotide,After special treatment,This medicine is very stable in the body,It can not be degraded by nucleic acid enzyme,Patients only need to take medicine once a week。This medicine is a new drug reduction medicine,But it is not My stake betting appan stake sports betting appordinary cholesterol drug,is an orphan medicine specifically for a rare disease,That is to target patients with family hypercholesteroemia.,This drug was originally developed by ISIS Pharmaceutical Company,After II clinical experiments,High price (more than $ 1 billion) sold to Genzyme, a subsidiary of Sanofi。Jianzan as the main company in the field of orphan drugs,Kynamro's new drug approval,once again consolidated its leading status in the field of orphana drugs。
 
There are two other highlights of new medicines,One is the Canagliflozin of Janssen Pharmaceuticals owned by Johnson & Johnson,This medicine is the first SGLT2 inhibitor approved in the United States,SGLT2 is a sodium -dependent glucose transport protein,So the indication of Canagliflozin is type 2 diabetes。It is worth mentioning that the medicine was originally developed by Mitsubishi Tanabishi Tanabe Pharma, a subsidiary of Mitsubishi, Japan,After transferring to Janssen Company,The other is the trametinib of GSK,This small molecular chemical medicine,It is the first new drug in history。
 
The above 11 companies,In addition to some well -known large companies (such as Takeda in Japan,Sanofer's Jianzan,Roche's gene Tike,Purcell gene,Baijian Eddie,Bayer,GSK),There are also some small and medium -sized companies with less reputation。
 
These companies that are unknown to the industry are unknown even in the industry.,The new drug approved by the company is ospemifene,Used to treat moderate to severe sexual intercourse (sexual dysfunction)。European Pharmaceutical Giants Astraika's famous cholesterol drugs Rosuvastatin (Rosuvastatin,Crestor,can be determined),It was successfully developed by the company;
 
2) Navidea,This is a biopharmaceutical company in Dublin, Ohio, USA,Only 26 years of history,is a small company in the real sense,Only more than 40 employees,This company and some hundred -year history、Pharmaceutical giants with tens of thousands of employees,Can't compare Stake Sports Bettingit My stake betting appat all,but,& ldquo;,Eat all over the sky & rdquo;,Although the company is small,But focusing on medical imaging and imaging related platform technology,FDA approved the company's first new drug TECHNETIUM TC-99m Tilmanocept is a radioactive agent,lymph -based imaging technology,Clinical diagnosis for breast cancer or melanoma,So,The drug itself is not therapeutic;
 
3) Similar new drugs,and Gadotiamine approved by the first half of this year,This is a contrast agent used to show blood brain barrier,It was successfully developed by Guerbet,GUERBET is a company headquartered in France's professional R & D manufacturing agent,At least three types of combo agents that have been approved for the listing for X -rays and MRI。The company is not too small,There are thousands of employees,Annual sales revenue of hundreds of millions of euros。