[drug Kajun] 2019 is a good start, 54 new drugs of category 1 are accepted, Haizheng, Beida, Erjian... And tadalafei generic drugs are coming!

Highlights: 1 In January 2019, 54 class 1 new drugs of the product specification were accepted; 2 The production of class 1 new drugs of Beida and Haizheng was accepted; 3 The domestic clinical application of class 1 new drugs under research by eljian, YANGSEN, BMS and other enterprises was accepted; 4 Tadalafil, the first heavy imitation drug, showed "approval in progress", with a sales volume of 3.932 billion US dollars in 2017; 5 Another enterprise was added to the competition for the first imitation of celecoxib capsule In January 2019 (as of January 25, 2019), CDE accepted the registration and application of 54 new drugs of category 1 of product specifications, 48 of which were reported clinically, involving 34 varieties; 6 of which were reported for production, involving 4 varieties In this week (January 18-24), 7 drug products showed "under approval", 26 drug products were accepted by CDE In January, CDE newly accepted the listing application of six new drugs of category 1 according to the regulations They are Haize Mabu APIs and tablets of Haizheng, Zhejiang Province, and ensatinib hydrochloride APIs and capsules of Beida pharmaceutical X-396 is a new molecular entity compound jointly developed by Beida pharmaceutical and its subsidiary xcoveryholdings, Inc., which has completely independent intellectual property rights It is a new generation of ALK inhibitor with strong effect and high selectivity It is "an innovative drug not listed at home and abroad" The drug is intended to be used in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after previous treatment with clozatinib or are resistant to clozatinib On January 23 this week, Beida released a notice, disclosing some latest clinical data The basis for ensatinib hydrochloride to apply for drug registration and listing is "phase II single arm, multi center clinical study to evaluate the efficacy and safety of x-396 capsule in the treatment of LK positive non-small cell lung cancer patients resistant to clozatinib" The results showed that ensatinib had good efficacy and safety in the treatment of LK positive NSCLC It can provide a new and effective treatment option for Chinese patients with ALK positive NSCLC In terms of efficacy, the overall Orr and disease control rate assessed by the Independent Review Committee (IRC) were 48.7%, 87.8%, 66.7% and 92.8% respectively The overall efficacy and intracranial efficacy achieved the expected targets In terms of safety, x-396 is well tolerated in patients with LK positive non-small cell lung cancer who are resistant to clozatinib The most common adverse reactions are rash, ALT rise and AST rise, most of which are mild to moderate After drug suspension and / or symptomatic treatment, it can be recovered or relieved, suggesting that ensatinib salt has a good controllable safety Haize Mabu of Haize Pharmaceutical Co., Ltd Haize Mabu is an innovative drug independently developed by Haizheng, and the same target drug that has been listed abroad is ezema (trade name "zetia"), which is mainly used for the treatment of primary hypercholesterolemia, homozygous familial hypercholesterolemia (hofh) and homozygous sitosteronemia (or phytosteroemia) It was approved to be listed in China in 2006 In 2017, zetia's global sales volume was about US $3.49 billion, and the sales volume in China was about US $10 million According to the announcement of Haizheng pharmaceutical, the company has invested about 238 million yuan in the research and development project of Haize Mabu In January, CDE newly accepted the clinical application of 48 new drugs of category 1, including 9 imported drugs, 32 chemical drugs of category 1, and 7 therapeutic biological products of category 1 Erjian agn-241751 agn-241751 is a new, oral, rapid acting antidepressant drug targeting at NMDAR, which is currently in phase II clinical development for the treatment of severe depression (MDD) Develop highly innovative antidepressant drugs for Allergan In July 2018, agn-241751 also won the FDA's fast track status of experimental drugs Agn-241751, as an important oral supplement of rapid acting antidepressant rapastinel, has a significant practical demand The latter is currently in phase III clinical development Xi'an YANGSEN pimodivir pimodivir (vx-787, jnj-63623872, jnj-872, vrt-0928787), the original research company is vertex pharmaceuticals, the development company is janssenpharmaceuticals, is a new influenza virus inhibitor, which can inhibit the replication of influenza virus, thus blocking the activity of pb2cap snapping in the influenza virus polymerase complex, and is suitable for the treatment of influenza A It is currently in phase II clinical development in the world Bms-986165 developed by Bristol Myers Squibb bms-986165 is an innovative oral specific Tyk2 inhibitor to treat psoriasis At present, it is in clinical practice On September 13, 2018, BMS announced that bms-986165 reached the primary end point of efficacy in the clinical phase 2 trial for patients with moderate to severe plaque psoriasis Later, the clinical phase 3 trial of bms-986165 in the treatment of moderate to severe psoriasis has been started, and the clinical phase 2 trial of bms-986165 in the treatment of lupus erythematosus and Crohn's disease is also in progress Cornerstone pharmaceutical blu-667 blu-667 is an oral, highly active, highly selective inhibitor of RET fusion, mutation and predictable drug-resistant mutations under development by blueprint medicine Non small cell lung cancer, medullary thyroid cancer, and other solid tumors used to treat RET gene changes Blu-667 has been granted orphan drug status by the U.S Food and drug administration On June 4, 2018, cornerstone pharmaceutical and blueprint medicines announced to reach an exclusive cooperation and licensing agreement to promote the clinical development and commercialization of three drugs in mainland China, Hong Kong, Macao and Taiwan, including blu-667, and blueprint medicines will retain all rights to related products in other countries around the world Beida pharmaceutical bpi-23314 Bpi-23314 is a new molecular entity compound independently researched and developed by Beida Pharmaceutical Co., Ltd., which has completely independent intellectual property rights It is "an innovative drug not listed at home and abroad" It is a powerful and highly selective oral small molecule inhibitor of bromine domain and end-of-line domain (BET) It can specifically inhibit the function of bet family protein, regulate the transcription and expression of cancer-related genes, and then affect the fine Cell growth, proliferation, apoptosis and other physiological processes, and ultimately achieve the goal of inhibiting tumor growth At present, the drugs targeted at bet are all in the early clinical stage, and there is no drug on the market at home and abroad Geli biological asc21 asc21 is the third innovative drug for hepatitis C of Geli company It is a nucleotide inhibitor combined with NS5B polymerase, which can prevent chronic hepatitis C virus infection by inhibiting the activity of NS5B polymerase Preclinical studies show that asc21 is an effective pan genotype drug with high resistance gene barrier GOLLY plans to use it in combination with ravidavir to treat patients with refractory, cirrhosis and HCV / HIV co infection By blocking the PD1 and PD-L1 immunosuppressive pathway, the anti-pd1 monoclonal antibody drugs of Anke biology and baiaotai biology can remove the immune escape function of tumor cells and restore the recognition and killing ability of immune cells to tumor At present, many domestic enterprises have entered the preclinical or clinical research stage of PD1 monoclonal antibody The first tier is currently approved to be listed by Cinda biology and Junshi biology In addition, Hengrui and Baiji Shenzhou have reported to be listed faster This week's review and approval dynamic report on the new status of the production of drugs January 18, Changchun Haiyue tadalafei tablet, a generic drug of Changchun Haiyue, showed "in the process of approval" Tadalafil was developed by Eli Lilly It was first approved by the European Drug Administration (EMA) on November 12, 2002, approved by the U.S Food and Drug Administration (FDA) on November 21, 2003, and approved by the Japanese pharmaceutical medical device integration Agency (PMDA) on July 31, 2007 Sold by Lilly in the UK and Germany under the name Cialis Tadalafil is a phosphodiesterase 5 (PDE-5) inhibitor It is used to treat erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) Compared with the main PDE5 inhibitors, tadalafil's sales and growth are very considerable, with sales of USD 3932 million in 2017 (photo source: article of "exclusive] Tadanafil Asian male trial" by yaozhi.com) at present, there are no generic drugs listed in China, and many enterprises have applied for generic drugs, including dongyangguang, Qilu, Zhengda Tianqing, humanwell pharmaceutical, etc At present, Changchun Haiyue has the fastest progress and has entered the "in approval" stage, or will be approved for the first time Changchun Haiyue's application was included in the drug clinical trial data on-site verification category catalog on January 30, 2017, and then was included in the 24th batch of priority review on November 22, 2017 on the basis of "drug production application one year before the expiration of patent" Among the 26 new drugs accepted this week, 7 are imported drugs, 1 is generic drugs, 19 is generic drugs, and 1 is important generic drugs On January 23, celecoxib capsule of Guowei Pharmaceutical Co., Ltd., Sichuan Guowei Pharmaceutical Co., Ltd accepted the listing application of celecoxib generic drugs Celecoxib is a cyclooxygenase (COX-2) inhibitor for the treatment of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis (as), acute pain (AP), primary dysmenorrhea (PD), and rheumatoid arthritis (JRA) in children over 2 years old Celecoxib was jointly developed by Pfizer and Astellas It was first approved by FDA on December 31, 1998, approved by EMA on October 17, 2003, and approved by PMDA on January 26, 2007 Pfizer is responsible for its listing in the United States and Europe, with the commodity names of Celebrex and onsenal respectively; Ansteel is responsible for its listing in Japan, with the commodity name of celecox At present, there is no domestic approval document for this drug preparation in China, only the API production approval documents of Jiangsu Zhengda Qingjiang Pharmaceutical Co., Ltd and Jiangsu Shengdi Pharmaceutical Co., Ltd There are 66 production acceptance numbers of celecoxib capsule imitations, 43 of which have been approved for clinical application with 6 categories of original chemicals At present, the enterprises declared according to the new registration classification are Hengrui (priority review), Jiangsu Zhengda Qingjiang (priority review), Qingdao Baiyang Pharmaceutical (priority review), Sinopharm Ouyi (priority review), Qilu, Tianjin Jinyao pharmaceutical, and Sichuan Guowei pharmaceutical Who should be expected to make the first imitation Data source: Yao Zhi data statement: This article only represents the author, not the position of Yao Zhi Com Welcome to exchange and supplement in the message area If you need to reprint, please be sure to indicate the author and source of the article.