Crazy pricing! Highlights and controversial points of Zhengda Tianqing dasatinib's listing at 1 / 8 of the price of the original research drug

Source: e-medicine Facebook July 24, 2014, Zhengda Tianqing's blockbuster new drug, dasatinib, has successively entered the record procurement in Shandong and Hubei, with the price only 1 / 8 of the original research drug In the view of the industry, this quotation is a crazy pricing strategy with courage and strength; not only the latecomers are basically sealed, but also the import substitution is expected to accelerate It is understood that in April and June, Zhengda Tianqing dashatini was successively incorporated into the record procurement of Shandong and Hubei provinces The price of 50mg specification is 70 yuan / tablet, and that of 20mg specification is 35 yuan / tablet, while the price of 50mg and 20mg of original manufacturer Bristol Myers Squibb is 526 yuan / tablet, and that of 20mg is 260 yuan / tablet The price difference is amazing 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 First of all, let us know about the listing of shatinib: Baishi Meishi Guibao obtained the import registration certificate of dashatini on September 7, 2011 Zhengda Tianqing successfully won the first imitation on September 17, 2013 We note that Bristol Myers Squibb has four specifications of 20mg, 50mg, 70mg and 100mg, while Zhengda Tianqing has only applied for and approved three specifications of 20mg, 50mg and 70mg It is understood that Shuanglu pharmaceutical is expected to win the second imitation, ranking 363 in the NDA sequence In 2013, 281 NDA review acceptance numbers have been completed At this speed, it is expected that dashatinib of Shuanglu pharmaceutical will complete the review in 15 months, plus the time for on-site verification and approval and certification, and it is expected that it will not be listed until the end of next year Moreover, when dashatinib of Shuanglu is listed, it is afraid that it will miss a batch of provincial and municipal bidding For other companies on the list, including hausen, there will be a fierce battle in the future Figure: the registration and application of dasatinib, especially Zhengda Tianqing's holding the first imitation advantage, playing a price war, making Zhengda Tianqing particularly prominent in market promotion Because CML is a chronic disease, if patients recognize a brand, they usually don't change it Zhengda Tianqing has a first mover advantage Secondly, considering the consumption habits of Chinese people, there are low-cost generic drugs, and ordinary people won't be willing to spend money to buy the original research drugs that are 8 times more expensive Zhengda Tianqing PK Shuanglu dashatini is a specific drug for the treatment of chronic myeloid leukemia It was listed by Bristol Myers Squibb in 2006 and imported to China for the first time 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 Shuanglu pharmaceutical has developed two crystal forms of dasatinib and applied for patent cn101891738 for protection 1 Time difference: the two manufacturers applied for clinical application almost at the same time, both of them were different from the original crystal type, but the final output was two years different 2 Does double Heron have advantages? Patent authorization means that the invention has significant progress compared with the existing technology, but the "progress" here is paper-based, which does not mean that there is substantial progress in the efficacy Only the drug regulatory department can certify that the drug has progress, but the drug can not apply for a patent until FDA or CFDA approves it Therefore, in the eyes of the patent office, new things generally have progress China's patented drugs have pricing advantages, but they don't have to be priced according to the patented drugs For example, you can apply for a patent on the drug packaging box, or develop a new drug production process, which are very easy, but it's difficult to sell high prices through this way Shuanglu has no ability to prove that his dasatinib is superior to the original research, or that his dasatinib is superior to Zhengda Tianqing In this case, the so-called patent is a piece of waste paper 3 Who is the first imitation? The first imitation refers to the first non-original research drug listed by domestic manufacturers The latter generic drugs must be priced according to its price, and must be lower than it It is obvious that Zhengda Tianqing is the first imitation, and the price it has set has come out The first copy had nothing to do with the 3 + 3 and 3 + 6 of the registration classification (nothing to do with the new drugs and generic drugs in the registration classification) It should be noted that Zhengda Tianqing relied on the cxhs120025-cxhs120028 four acceptance numbers Like Shuanglu pharmaceutical industry, it went according to the 3 + 3 procedure Zhengda Tianqing declared in September 2012 and got the approval number of CFDA in 2013, which took a whole year Shuanglu declared in April 2014 and could be approved at least next year Moreover, there is dasatinib in the market now, and CDE is not too anxious to review the second one, so Shuanglu can only watch Zhengda Tianqing attack the city 4 Where does Zhengda win? In the PK of Zhengda Tianqing and Shuanglu pharmaceutical industry, it can be said that Shuanglu pharmaceutical industry has failed completely Now, we can only watch the products of Zhengda Tianqing enter into various provinces and cities for sale, while our own products are still in line with CDE The two manufacturers apply for clinical application almost at the same time, both of which are different from the original research crystal form, but the final output is two years different Shuanglu should deeply reflect on why he did so slowly? This is really worth double Heron's reflection, but we have to say that double Heron does have an idea Applying for a crystal patent is nothing more than eating alone, but we should not despise the research and development ability of the opponent If you can solve the crystal problem, others may also solve it The fast one should do it with all his strength For generics, it is more important to take the lead than to eat alone Shuanglu thinks that with a patent, everything will be OK, and he falls short Zhengda Tianqing has entered the market by virtue of its first mover advantage and patent evasion Insiders point out that provincial bidding may be opened in the second half of the year In the bidding environment with "two standards in one" as the general trend, Zhengda Tianqing dashatini will take advantage of its first imitative qualification and pricing advantage to take the lead in layout in each province, and the marketing difficulty of Shuanglu pharmaceutical will be greatly increased after being approved This article synthesizes the medicine magic cube, the doubt night, the big wisdom correlation content