[yaocajun] Hengrui has applied for new drugs to be put on the market again. Zhengda Tianqing "fukewei" has the new year's indications, plus the first heavy imitation. Lilai and AstraZeneca

Highlights: 1 It's a happy day for both sides, with new indications and heavy weight of monoclonal antibody; 2 Lilaiqizhumab injection brings new hope for 6 million patients with psoriasis; 3 The lung cancer star drug oshitinib has become a first-line drug; 4 Pregabalin, with sales of more than 60 billion, will welcome new domestic competitors There are 38 new developments of review and approval in this week (August 30 to September 6) and the review and approval status of production acceptance number (22 varieties) is updated There are two varieties of new drugs and imported drugs, 18 generic drugs; it is worth noting that the new indications of Zhengda Tianqing's amlotinib hydrochloride capsule are approved for production, and ixekizumab injection of Lilly is approved for import; in addition, olacetam injection of Ma'anshan Fengyuan pharmaceutical and bortezomib for injection of Chengdu Tongde pharmaceutical fail to pass the customs clearance, which is not approved See the following table for more details: As a new type of small molecule multi-target receptor tyrosine kinase inhibitor, it can effectively inhibit VEGFR, PDGFR, FGFR, c-kit and other kinases, and has dual effects of anti-tumor angiogenesis and tumor growth inhibition At present, it is the only single effective oral preparation in the anti angiogenesis targeted drugs for advanced non-small cell lung cancer In 2018, enrotinib hydrochloride capsule was approved for the treatment of advanced non-small cell lung cancer In June this year, it was approved for the treatment of soft tissue sarcoma This week, the third indication of this product was approved for the market - the third line treatment for small cell lung cancer patients It is worth noting that the listing price of androtinib is 6200 yuan / box (885.71 yuan / capsule) After negotiation, the price of arotinib was reduced by 45%, and it was successfully included in the national medical insurance drug catalog at the price of 487 yuan / pill (12mg) According to the analysis of CITIC Securities, we learned from the grass-roots research that the sales momentum of arotini is strong The sales volume on the first day of listing in June reached 130 million yuan, and it has exceeded 300 million yuan in August The sales volume is faster than the market expectation It is expected that the annual sales volume will exceed 700 million yuan, which is expected to become the fastest innovative drug in China In addition, CITIC Securities Analysis believes that the sales volume of arotini is expected to continue to exceed the market expectation, and the peak sales volume is expected to exceed 4 billion yuan Fosapitam for injection fosapitam for injection fosapitam for injection is a selective high affinity receptor blocker of substance P / neurokinin-1 (NK-1), which is used as an adjuvant of chemotherapy in the process of tumor treatment to prevent nausea and vomiting caused by chemotherapy The original research enterprise is MSD, which was approved by FDA in January 2008 and EMA in November 2008 In 2018, the global sales of emend (including oral and injection) reached 522 million US dollars According to the statistics of drug registration and acceptance database, at present, there are no domestic imitated drugs of fosapitam for injection on the market There are 44 application documents for registration Only four acceptance numbers of Qilu, hausen and Zhengda Tianqing are reported for production Qilu and hausen's varieties are still under review and approval, and Zhengda Tianqing will be approved for the first time In 2015, fosapitam diglucomethylamine for injection of Zhengda Tianqing was put on the market According to the application of class 3.1 new drugs, after 722 clinical field verification, it was included in the priority review in September 2017, and after three rounds of supplementary information, it took four years to finally get the results Ixekizumab injection (iqizumab injection) is a targeted IL-17A inhibitor for the treatment of adult patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy In August 2018, it was included into 48 overseas listed new drug names urgently needed by the State Drug Administration At the end of February this year, it was declared for import, only six months after the approval was completed, and it was approved quickly, bringing good news to the patients with psoriasis in China It is reported that there are more than 6 million patients with psoriasis in China, which has a bright future in the domestic market As of March 2019, iquzumab injection has been approved for marketing in 57 countries and regions around the world Oxitinib mesylate tablets recently, two and a half years after its first launch in China, will soon be approved as a new indication for the first-line treatment of EGFR mutation positive local advanced or metastatic non-small cell lung cancer It is reported that oshitinib is the first EGFR-TKI drug identified by FDA as having positive OS results compared with the first generation EGFR-TKI According to AstraZeneca mid-2019, 84 countries in the world regard Teresa as the second-line treatment, 74 countries are approved as the first-line treatment, and markets in the United States, Europe and Japan have seen high growth Teresa's revenue in the first half of 2019 increased by 92% In addition, oxitinib mesylate tablet is the representative of high-priced tumor drugs, which is about 50000 / month (80mg30 tablets) in China In October 2018, it entered the national medical insurance catalogue through the "special negotiation on medical insurance access of anticancer drugs" As a second-line therapy for advanced non-small cell lung cancer, the decrease rate reached 70% Now it is approved as a first-line therapy, or it will further improve the market sales In addition, Haosen's ometinib mesylate tablets are currently in the process of accelerated listing as priority review and special review If it goes on the market smoothly, it will challenge the original R & D New developments in review and approval of new acceptance: the good news of this week's listing is continuous, and we dare not lag behind in reporting production acceptance This week, 20 acceptance numbers and 12 varieties were reported for production acceptance, and the 2.2 new drug pregabalin sustained-release tablet of Hengrui is worthy of attention Pregabalin sustained release tablets pregabalin is a GABA analogue developed by Pfizer In July 2004, EMA approved it for the first time for the treatment of partial seizures In December of the same year, the US FDA approved pregabalin for the treatment of diabetic peripheral neuralgia and postherpetic neuralgia; in June 2005, pregabalin was approved as an adjuvant for the treatment of partial epilepsy; in June 2007, pregabalin continued to be approved by the FDA as the first drug for the treatment of fibromyalgia syndrome; in June 2012, the FDA approved pregabalin as the first drug Drugs for the treatment of neuralgia caused by spinal cord injury; approved by FDA in 2017 for the management of neuropathic pain related to diabetic peripheral neuropathy, and for the management of postherpetic neuralgia At present, it has been approved by more than 130 countries and regions According to the database of pharmaceutical sales, Pfizer's pribalin sales have been on the rise since its launch, reaching a global sales volume of 64.784 billion yuan in 2018 In addition, according to the pharmaceutical intelligence data, only Pfizer and Chongqing Saiwei pharmaceutical are approved to be listed in the domestic market of pregabalin, and only "capsule" dosage forms are listed in Chongqing Saiwei pharmaceutical, while no enterprises are listed in the sustained-release tablets, and Sichuan Kelun and Qilu pharmaceutical are also under development For some information, please refer to: yaozhi.com, enterprise announcement, CITIC Securities statement: this opinion only 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