[Yao Kejun] drug review week: Hengrui first imitates and surpasses the original research; 10 billion prostate new drugs are approved for import; Nuo Cheng Jianhua's first new drug is applied for listing

The world's best-selling and heavyweight prostate new drug with a focus of more than 10 billion yuan has been approved for import; Hengrui medicine is the first to take the lead in the original research and is the first to be listed in China; Xintai Pharmaceutical Co., Ltd has entered the Bureau of fondagangui sodium injection, which has impacted the original research and Hengrui; Nuo Chengjianhua has submitted the first application for the listing of new drug albutine The new trend of nmpa approval 28 times reported to the production acceptance number (22 varieties) for approval this week, including 14 injections, many of which are heavyweight varieties, and the approval is on the way to market; in addition, the imported drug anzalutamide soft capsule has successfully entered China, with more details as follows: the new trend of production acceptance drug approval details of this week's report anzalutamide soft capsule Enzalutamide soft capsule is the second generation of androgen receptor antagonists, which is used for metastatic hormone sensitive prostate cancer It was jointly developed by medivation company of the United States and ansterai company of Japan, with the trade name of "xtandi" It was approved by FDA in August 2012 and listed on the market It is the first oral drug approved by FDA for both metastatic and non metastatic castration resistant prostate cancer It is worth mentioning that as soon as nzalutamide is listed on the market, it has become the world's anti-tumor heavy explosive ammunition, one of the top ten best-selling drugs in the world In 2018, the global sales reached 23.62 billion yuan According to the prediction of evaluatepharma, the drug ranked the fourth in the world in terms of tumor drug sales in 2021, and became the second in terms of sales of all products in Europe and the best-selling tumor drug in Europe in 2022 According to the pharmaceutical intelligence data, the patent period of nzalutamide is expected to be 2026 However, due to the successful challenge of the invention patent by Xingtai pharmaceutical, a subsidiary of Fosun Pharmaceutical, it has broken the original research patent barrier for domestic enterprises So far, six domestic enterprises have applied for registration, all of which have obtained clinical approval This week's first approval of the original research drug in China has brought new drug options for prostate cancer patients in China, while at the same time forcing domestic enterprises to accelerate R & D and compete for the market Fondagangui sodium injection is a kind of synthetic pentasaccharide similar compound, which is used in the major orthopedic operation of lower limbs, such as hip fracture, major knee operation or hip replacement, to prevent the occurrence of venous thromboembolism Fondaparinux sodium was developed by the American company mylanirellandldtd It was first approved for marketing by FDA on December 7, 2001 and listed in China in 2008 According to IMS database, in 2017, the sales volume of fondaparinux injection in the Chinese market was about $2.94 million, the sales volume in the U.S market was about $69.53 million, and the sales volume in the global market was about $190 million At present, in addition to the original research, in 2018, Hengrui medicine was approved as the first one by priority review, and was approved by FDA for listing in the same year In addition to Hengrui, there are seven domestic enterprises that have reported to produce the product This week, Xintai pharmaceutical's second one was approved, and will compete with the original research enterprise and Hengrui pharmaceutical to compete for the cake market Esmketamine hydrochloride injection esmketamine hydrochloride injection is a derivative of ketamine It is a heavy-duty antidepressant developed by Johnson & Johnson It is mainly used in the treatment of surgical analgesia, sedation and severe depression It is the first antidepressant with new mechanism approved by FDA in recent 30 years According to statistics, the global sales volume of esmketamine hydrochloride injection in 2017 was about 12 million US dollars According to Chi Chi data, at present, the original varieties of the variety are not listed in China yet, but Johnson hydrochloride ketamine ketamine spray has been in the 3 phase clinical trial The domestic company Heng Rui medicine has been successfully run ahead of the first prize, leading the original research and approval, and is about to get the first imitation qualification This week, 18 new CDE production acceptance numbers (14 varieties) were submitted for review and approval, including 2 new drugs, 1 imported drug and 11 generic drugs This week's detailed list of drug acceptance for registration and listing is worth noting that the first application for listing of new drug albutine submitted by Nuo Chengjianhua has been accepted Obutinib is a highly selective and irreversible Btk small molecule inhibitor for the treatment of tumor and autoimmune diseases At present, a number of clinical studies are under way by ncjh on obutini In addition to the indications for the first NDA submission, there are also a number of indications in the clinical research According to the announcement, in the United States, the phase I clinical trial of obutini on B-cell malignant tumor was approved to start in May 2019 According to the official website, the R & D team of Nuo Chengjianhua has developed nine candidate drugs with the potential to become bestinclass and firstinclass, including one candidate drug in the registration test, two candidate drugs in phase I / II clinical trials and six candidate drugs in the preparation stage of ind Photo source: ncjh official website † unless otherwise specified, all R & D status refers to the status in China Abbreviations: CLL = chronic lymphocytic leukemia; SLL = small lymphocytic lymphoma; MCL = mantle cell lymphoma; MZL = marginal zone lymphoma; CNSL = central nervous system lymphoma; GCB = germinal center B cell; DLBCL = diffuse large B cell lymphocarcinoma; WM = Fahrenheit megaglobulinemia; FL = follicular lymphocarcinoma; SLE = systemic lupus erythematosus; HCC = liver cell carcinoma *Refers to our core candidate product, ibtinib (icp-022) **Some indications may not require unregistered phase II clinical trials before the start of phase II or phase III clinical trials ***Some trials may need to complete phase III clinical trials before submitting a new drug application ****After the ind application, we launched the registration test in China Obutini is the fastest developing new drug under NCC Jianhua and the first product submitted to NDA by NCC Jianhua It has the potential of "best in class" It is of epoch-making significance to accept this application for listing Information source: network public information data sources such as yaozhi.com, yaoguanlan and enterprise announcement: network public data such as yaozhi.com, yaoguanlan and enterprise announcement With 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