Shiyao overtakes again, and becomes the "second imitation" manufacturer of dashatini tablets?

The recent drug registration of Petrochemicals Group in China is really eye-catching For example: ① when petrochemicals and Hengrui are out of the game, the time left for metformin may not be much longer; ② when petrochemicals "montelukast sodium chewable tablet" is approved by FDA, it will "disturb" the consistency evaluation? Before long, the stone medicine gave you a surprise again According to the information on the CDE website on May 5, the production application of Ouyi pharmaceutical dashatini tablet of Shiyao group was officially accepted by CDE with the acceptance number of chys1790027 / 8 / 9 Generally speaking, the first 2 digits in the acceptance number represent the acceptance year, and the last 5 digits represent the acceptance serial number However, if the serial number of the acceptance number starts with 9, it means that the enterprise directly sends the data to the drug examination center of the State Administration for production after completing the bioequivalence Dasatinib is a heavyweight drug developed by BMS for the treatment of chronic myeloid leukemia (CML) In 2016, the global sales volume reached 1.824 billion US dollars At present, there are only the first imitations of BMS original research and Zhengda Tianqing in China, with 17 enterprises under research At present, petrochemicals is the fastest one among these 17 enterprises to apply for production and is expected to become the "second imitation" enterprise of dasatinib tablets Speaking of this, we have to mention Shuanglu pharmaceutical industry Zhengda Tianqing and Shuanglu are the first two manufacturers to apply for dasatinib in China They applied for clinical application according to class 3.1 new drugs in June 2010 and August 2010 respectively Although Shuanglu pharmaceutical industry is two months late, it also has its own advantage, that is, it has broken the original research crystal patent, which does not constitute a barrier to listing But in the process of clinical trials, Shuanglu pharmaceutical industry was gradually left behind by Zhengda Tianqing Dashatinib of Zhengda Tianqing was applied for production on September 24, 2012, and approved for listing on September 17, 2013 However, Shuanglu's production application (April 1, 2014) was delayed until Zhengda Tianqing's product was listed As a result of "procrastination", dashatinib of Shuanglu Pharmaceutical Co., Ltd caught up with the clinical data on July 22, 2015 for self-examination.. In this way, from the difference of the first two months, Shuanglu and Tianqing became the last to be listed as the first imitator, with boundless scenery, and one to return with defeat and tragic withdrawal Now, the group's dashatinib (6 categories) has also applied for listing, which adds some sadness to the dashatinib (3.1 categories) of Shuanglu pharmaceutical Ouyi, a stone drug, applies for listing according to six categories of drugs, that is to say, it only makes be, with short time and low cost Shuanglu applied for clinical treatment according to the new drug category 3.1 in that year, and made great efforts to do confirmatory clinical treatment after being approved However, she was unlucky and suffered withdrawal On the contrary, it made the stone medicine become the "second imitation" manufacturer of dasatinib However, in the development competition of dasatinib tablets, it is not only Shuanglu pharmaceutical industry that has been overtaken by stone medicine Nanjing Shenghe is the third enterprise applying for clinical application in China, which also applies for new drugs according to category 3.1 However, according to the information displayed on the publicity platform of clinical trials, the be trial of Shenghe pharmaceutical passed the ethical review on March 25, 2015, which is still in progress and has been done for more than two years However, it took only three months for the stone drug to start the be on June 8, 2016 and complete it on September 24, 2016 In fact, Haosen, Youke, chuangnio, Qilu, Sinopharm Yixin and other enterprises have received the clinical approval documents (Category 6) no later than stone medicine, but at present, only stone medicine has completed be and reported for production On the one hand, it shows the importance of the speed of clinical trials in the success of generic drugs On the other hand, it reminds us that the work efficiency of the provincial bureau is really crucial.. It should be noted that the specifications of dashatinib tablets of BMS include 20, 50, 70 and 100mg, while Zhengda Tianqing and Shiyao have only developed three specifications, which are supposed to be 20, 50 and 70mg Shenghe is made up of 4 specifications That is to say, if Shenghe completes be as soon as possible, it will still have the opportunity to become the first manufacturer of dashatini 100mg in China Finally, I will add some background information of dashatini as the end of today's story Dasatinib is a BCR ABL inhibitor BCR abl fusion gene exists in 95% of CML, 20% - 30% of all and 2% - 5% of all in children Other BCR ABL inhibitors on the market include imatinib, radotinib, ponatinib, bosudinib and nilotinib In China, only three BCR ABL inhibitors, imatinib, nilotinib and dasatinib, are on the market Imatinib is the first bcr-abl tyrosine kinase inhibitor, and also the first small molecule targeted anticancer drug in the world Imatinib has greatly prolonged the survival period of CML patients, and soon became the first-line drug of CML However, with its wide application, drug resistance has also rapidly emerged, so the second generation bcr-abl inhibitors such as dasatinib came into being The binding of dasatinib to bcr-abl is not as strict as imatinib's conformation requirement, so it can be used for all BCR ABL kinase mutations except t3151 Dasatinib vs imatinib binding site in 2006, dasatinib was first listed in the United States for the treatment of drug-resistant or intolerant Ph + all patients and Ph + CML patients Later, the indication of dasatinib was extended to the newly diagnosed Ph + CML patients In 2016, the global sales of BMS dasatinib reached US $1.824 billion, a record high 10 years after its listing BMS dasatinib global sales