The price of Zhengda Tianqing dasatinib is only 1 / 8 of the original research drug, and the import substitution is also expected to accelerate

In April and June, Zhengda Tianqing dashatini was successively incorporated into the record procurement of Shandong and Hubei Province The price of 50mg specification was 70 yuan / tablet and 20mg specification was 35 yuan / tablet, while the price of 50mg and 20mg of original research manufacturer Bristol Myers Squibb was 526 yuan / tablet and 260 yuan / tablet, with a staggering price difference It is worth noting that in Hubei's record procurement, both Zhengda Tianqing and Bristol Myers Squibb have been selected, but the price gap is obvious; while Shandong market has seen signs of import substitution, and Zhengda Tianqing dominates the whole market Dasatinib is a specific drug for the treatment of chronic myeloid leukemia It was listed by Bristol Myers Squibb in 2006 and first imported to China in 2011 At present, it is only sold in Hainan, Yunnan, Hubei, Jiangsu and Jilin provinces In China, only Zhengda Tianqing and Shuanglu pharmaceutical have declared according to category 3.1, and other manufacturers have declared production according to category 6 generic drugs since 2013 Zhengda Tianqing started the project development of this product in 2009 It took 4 years of unremitting efforts to explore new process routes, and finally successfully developed dasatinib In the process of research and development, scientific researchers strictly control all impurities according to the technical requirements of the European drug review agency (EMEA), so that the total impurity content of "enishu" is less than 0.2%, and the single impurity content is about 0.05% The purity of Zhengda Tianqing "yinishu" is more than 99.8%, the stability is good, and the quality is not inferior to the imported preparation At present, Shuanglu Pharmaceutical Co., Ltd is still in the stage of "review", and the company expects to be approved for production by the end of the year Before that, the company also made its first attempt Shuanglu pharmaceutical has repeatedly questioned Zhengda Tianqing's patent for the drug It has pointed out that the patent protection period of dasatinib is about 10 years, and other enterprises' listing and sales within the patent period constitute infringement Many foreign new drugs have obtained the production approval for the imitations of many manufacturers during the patent period, "but all enterprises dare to go on sale only the next day after the patent expires" However, Zhengda Tianqing has entered the market by virtue of its first mover advantage and patent evasion Insiders pointed out that provincial bidding could be opened in the second half of the year In the bidding environment of "two standards in one", Zhengda Tianqing dashatini will take advantage of its first imitative qualification and pricing advantage to take the lead in layout in each province After being approved, the marketing difficulty of Shuanglu pharmaceutical will be greatly increased Add Dasatinib, formerly known as BMS-354825, is a cancer treatment drug produced by Bristol Myers Squibb and sold in the name of "sprycel" In 2012, Zhengda Tianqing evaluated the bioequivalence of "enisu" with "starxay" produced by Bristol Myers Squibb as the reference preparation The results showed that the pharmacokinetic parameters of the two preparations were the same, and the bioavailability of "yinishu" relative to "shidasai" was 115.8%; the product of Zhengda Tianqing was bioequivalent with the imported preparation, and the safety indexes were the same In the course of CML treatment, a considerable number of patients are resistant to imatinib, and with the increase of the number of years of treatment and the aggravation of the disease, the probability of drug resistance also increases Dasatinib is the life-saving drug for these patients Dasatinib was approved by FDA on June 28, 2006 and entered China in September 2011 However, at present, dasatinib is only sold as an imported preparation, which is expensive and not affordable for ordinary families The high drug price makes the patients with imatinib resistance unable to pay can only watch the disease worsen Domestic patients have been looking forward to the listing of domestic dasatinib for a long time The approval of Zhengda Tianqing dasatinib to market will fill the gap of this product in China, break the current situation of high price of imported drugs, reduce the cost of clinical treatment, and open a life door for patients with leukemia who are intolerant to imatinib