In the first half of this year, who will be the winner of opening up the international market?

In the increasingly competitive international market, pharmaceutical companies from China are no longer rare On the basis of NDA, anda becomes an important reference factor to judge the international market position and competitiveness of a pharmaceutical enterprise In terms of quality and quantity, compared with the performance of Anda of Chinese pharmaceutical enterprises in 2016, the performance of each player in the first half of 2017 was better than that of other players First of all, the emergence of European medicine In 2016, only one metformin hydrochloride tablet was approved by andI, and only four of them were approved in the United States from 2008 to 2015 In the first half of 2017, three andas, namely montelukast sodium chewable tablets, clopidogrel bisulfate tablets and montelukast sodium tablets, were approved by Ouyi Secondly, Jiangsu Hengrui's heavyweight attack In January and February 2017, Jiangsu Hengrui's atracurium CIS benzenesulfonate injection and docetaxel injection were respectively approved One is the heavyweight product of Hengrui, with domestic sales of nearly 1 billion yuan in 2015; the other is one of the most commonly used anti-tumor drugs in clinical, with a market space of nearly 500 million dollars in the United States And regular visitors to the approved list of Anda in the United States, such as Huahai, Renfu, Nantong Lianya, will not be absent in 2017 Huahai, through its US subsidiary Princeton, has achieved three batches of Anda The indication range includes the main field of hypertension, and it has begun to further expand its spiritual product line Indomethacin sustained release capsule of Nantong Lianya has been approved successfully Humanwell pharmaceutical, through its wholly-owned subsidiary epic, has obtained anda of gabapentin capsule for the treatment of epilepsy 2 In 2016, the total sales in the United States reached 200 million dollars As of June 26, 2017, the application for anda of Chinese pharmaceutical enterprises 1 Ouyi: a new force emerged In the first half of 2017, Ouyi's performance in the approval of Anda was one of the highlights On the one hand, it is reflected in the progress of quantity With "innovation" and "internationalization" officially becoming the two core strategies of the group, the group has made great efforts in the layout of internationalization According to the information statistics on the official website of FDA, up to now, the group has 8 anda batches, 3 of which were obtained in the first half of 2017 Zhang Heming, vice president of Shiyao group, said in an interview with the media that at present, in addition to the 8 anda varieties that have been reported to the US FDA for approval, there are 17 varieties under development in Shiyao group At the same time, the first-class new drug butylphthalide soft capsule of Petrochemicals Group has also carried out phase II clinical practice in the United States, and the new drug application (ind) of Mitoxantrone Hydrochloride liposome injection in the United States has also been submitted to the FDA in March 2016 On the other hand, it is embodied in quality Previously, the product metformin hydrochloride tablets approved by anda of Ouyi Pharmaceutical Co., Ltd of petrochemicals have appeared in the list of CDE's proposed priority review, and the reason given by CDE is "generic drugs produced in the same production line and listed in the United States and applied for domestic listing" According to the relevant provisions of the consistency evaluation of the quality and efficacy of generic drugs, the drugs produced in the same production line in China and approved for marketing in the European Union, the United States or Japan are deemed to pass the consistency evaluation after the consistency evaluation is reviewed and approved according to the formula That is to say, the group can take the lead in killing the domestic market by applying for anda in the United States 2 Jiangsu Hengrui: tumor drug cluster has now returned to Jiangsu Hengrui, the leader of research and development As the most R & D-oriented pharmaceutical company in China, Hengrui pharmaceutical has been not obvious in the number of Anda approvals So far, Hengrui pharmaceutical has only 7 anda approval numbers However, it is not difficult to find out from the list of varieties that Hengrui is characterized by being small and precise Although the number is small, almost the approved products are heavyweight products that can bring a lot of profits On January 27, 2017, the Anda application of atracurium CIS benzenesulfonate, a narcotic drug of Hengrui medicine, was approved by FDA As one of the heavyweights of Hengrui medicine, its domestic sales volume in 2015 was nearly 1 billion yuan In the United States, atracurium has three suppliers, namely abbvie, Sandoz and Fresenius kabi, with a market size of about US $51 million After Hengrui's products are launched, the sales peak is expected to reach US $12-15 million Although the market volume is relatively small, the drug is still expected to help Hengrui's export business growth in the second half of 2017 Another approved docetaxel is one of the most commonly used anti-tumor drugs in clinic Before that, irinotecan, letrozole, oxaliplatin, cyclophosphamide and other approved anti-tumor drugs of Hengrui medicine in the United States were all anti-tumor drugs Therefore, the approval of docetaxel also marks the further enrichment of Hengrui's anti-tumor echelon, which is gradually forming an anti-tumor drug cluster 3 Huahai pharmaceutical: a group of enterprises represented by Huahai pharmaceutical, humanwell pharmaceutical and Nantong Lianya are gradually becoming the representatives of Chinese pharmaceutical enterprises in the U.S market, which can be seen from the continuous and stable batch number flow of Anda of several enterprises every year In the first half of 2017, Huahai pharmaceutical, through its US subsidiary Princeton, obtained three anda batches, namely duloxetine hydrochloride enteric coated capsules, Telmisartan Tablets and olmesartan ester hydrochlorothiazide tablets Intersecting with the previous characteristics of the main battlefield in the field of hypertension, the approval of duloxetine enteric coated capsule marks the further enrichment of its spiritual products Previously, Huahai pharmaceutical acquired the Charlotte factory in the United States in December 2016, and obtained 27 anda approvals at one stroke, mainly focusing on the control drugs of spirit and anesthesia Therefore, as a mental drug for the treatment of depression and generalized anxiety, the approval of duloxetine enteric coated capsule can form a cluster effect with its Charlotte factory Telmisartan, which is still in the field of hypertension, provides Huahai with the opportunity of import substitution As early as 2014, the patent of Telmisartan Tablets has expired Later, Watson Laboratories Inc successfully challenged the patent and obtained 180 days of market monopoly Due to the expiration of the patent, there are 13 generic pharmaceutical companies in the U.S market to obtain 39 different specifications of Anda, so the competition is still fierce However, considering that Huahai pharmaceutical is the largest supplier of sartan APIs in the world, it is expected to gain market share through cost advantage However, the greater advantages are reflected in China First, it belongs to the class B medicine of national medical insurance Moreover, 80% of the market is still occupied by the original research enterprise Bi, and the import substitution is very inadequate Therefore, the approval of the medicine in the United States gives Huahai an opportunity in the domestic market 4 Fosun Pharma: wait for a surprise Although at present, there is no domestic pharmaceutical giant Fosun Pharma in the US anda, it can not be ignored that in a short time, Fosun Pharma will also participate in the competition of Anda If it doesn't come, it will be a surprise This is because gland, an Indian pharmaceutical company previously acquired by Fosun Pharmaceutical, has always been one of the most common figures in Anda applications in the United States Although Chen Qiyu, chairman of Fosun Pharmaceutical, said in an interview with the media that Fosun Pharmaceutical mainly focuses on gland Pharma's strong R & D ability and quality control system in the field of injection, from an objective perspective, dozens of Anda batches owned by gland Pharma will also become an important resource of Fosun Pharmaceutical in the international market According to the data on the FDA website, gland has 43 anda batches, most of which are injections.