[yaocajun] 198 approved traditional Chinese medicines, 40 "issued"; Btk inhibitor of Baiji Shenzhou, the first "Yaowang" biological similar medicine in China, the first Parkinson's imitated medicine

Last week (August 25 to August 31), there were some important developments in the review and approval of new drugs and generic drugs in China The details are as follows: CDE drug processing status update report to new drug production: 198 new drugs of traditional Chinese medicine were approved, followed by 40 new drugs showing "issued" In last week's "approval pending certification" of 198 new drugs of "approval pending certification" of "drug Kejun", all of which are traditional Chinese medicine; a number of heavy first imitation competitive drugs are in explosive scramble to go on the market, and Zhejiang Jingxin first imitation.. ", 198 new drugs of traditional Chinese medicine showing" approval pending certification "were compiled and sorted out (based on the acceptance number, the same below) This week, 40 of these drugs are in the same state It has been updated to show "issued products" Among them, Changzhou Tianpu pharmaceutical has 7 drugs, Jiangsu Kangyuan pharmaceutical has 4 drugs, Hefei Jinyue pharmaceutical has 3 drugs, as shown in the following figure: it is reported to produce generic drugs: Jingxin Parkinson's drugs are first imitated on the market, Shanghai New creatine phosphite shows "issued products" Zhejiang Jingxin Parkinson's treatment drugs are first imitated on the market in China On August 27, pramipexole hydrochloride tablets of Zhejiang Jingxin Pharmaceutical Co., Ltd were approved and first imitated Pramipexole hydrochloride tablets are the signs and symptoms for the treatment of idiopathic Parkinson's disease developed by bringer Ingelheim Pharmaceutical Co., Ltd Jingxin pharmaceutical is the first enterprise to submit pramipexole hydrochloride tablet listing application, and was included in the priority review by CDE on December 18, 2017 due to the "first imitation" After Beijing New Pharmaceutical Co., Ltd., Xiansheng Dongyuan, Qilu Pharmaceutical Co., Ltd and Ouyi Pharmaceutical Co., Ltd of Shiyao group also reported production successively On August 27, Shanghai Xinya's Sodium phosphocreatine drug substance and its injection showed the "hair piece" The drug is mainly used to protect the abnormal myocardial metabolism under the condition of myocardial ischemia by adding the cardioplegic solution during the cardiac operation At present, 4 domestic enterprises have approval documents for APIs, and 6 domestic enterprises have approval documents for injections Report of new drugs undertaken by CDE: Baiji Shenzhou has applied for drug listing for the first time in China, and zanubrutinib, Btk inhibitor of Baiji Shenzhou, has applied for listing for the first time On August 29, zanubrutinib, a new chemical drug of Baiji Shenzhou, was applied for listing, which is also the first drug of Baiji Shenzhou in CDE Zanubrutinib (Btk inhibitor) is a potential therapy for patients with recurrent / refractory mantle cell lymphoma (MCL) At present, Baiji Shenzhou is also developing as a single drug and combined with other therapies to treat a variety of hematological malignancies around the world Ebtinib is the first Btk inhibitor in the world, which was approved by FDA in November 2013 At present, the indications of ebtinib include chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, Waldenstr ö m macroglobulinemia In the first half of 2018, ebtini's global sales were $2819 million AstraZeneca acalabrutinib is the second Btk inhibitor in the world Zanubrutinib is expected to become the third Btk inhibitor in the world On August 27, the first domestic application for the listing of adamumumab similar drugs was accepted, and Baiao biological adamumumab injection was accepted Adalimumab, trade name xiumeile, is a kind of antibody drug developed by EBV It has been approved to treat rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis, purulent sweat adenitis, uveitis and other different indications in the United States and European Union since 2002 In 2017, xiumeile's global sales reached US $18.5 billion, and so far, its cumulative sales have exceeded US $100 billion, known as the "king of medicine" in the world At present, xiumeile has been approved for three indications in China: rheumatoid arthritis, ankylosing spondylitis and psoriasis At present, there are no listed varieties in domestic enterprises, and there are many enterprises under research, including Qilu, Zhengda Tianqing, Haizheng, Xinda biology, etc Report for production of generic drugs: 3 varieties compete for the first copy, and many varieties declared according to the new classification, if approved, will seize the listed generic drug market, dongyangguang 2 varieties will be declared for listing, and entacapone tablets may be listed for the first copy This week, olanzapine tablets and entacapone tablets declared by dongyangguang were undertaken on 27th and 29th respectively At present, entacapone tablets only have imported drugs in China, and there are three domestic enterprises including dongyangguang, all of which are old six kinds of applications, which have been approved for clinical application Currently, only dongyangguang has declared four kinds of chemicals and has entered the Anda sequence, which is likely to be the first imitated listing Entacapone tablet can be used as an adjuvant of the standard drug levodopa / benzhydrazine or levodopa / carbidopa to treat Parkinson's disease and end-of-life phenomenon (symptom fluctuation) which can not be controlled by the above drugs On August 30, Jiangsu Haosen and Suzhou Teri declared four generic drugs of erlotinib hydrochloride Erlotinib was approved by FDA in 2004 as the first EGFR-TKI inhibitor Erlotinib is suitable for locally advanced or metastatic NSCLC after the failure of at least one previous chemotherapy regimen As early as 2013, Jiangsu Haosen applied for the domestic listing of generic drugs, while Suzhou Teri also applied for the domestic listing in 2015, and all of them were approved to continue to do relevant clinical trials There are many domestic enterprises that have applied for listing At present, Shanghai chuangnio Pharmaceutical Co., Ltd is at the forefront The application acceptance number of the enterprise has been included in the priority review, followed by Nanjing Youke Pharmaceutical Co., Ltd which was undertaken in June, 2018 It is worth looking forward to who will be the first to imitate flowers Solafinil toluenesulfonate tablets of Jiangxi Shanxiang Pharmaceutical Co., Ltd joined in the first imitation war On August 27, sulafinil toluenesulfonate tablets declared by Jiangxi Shanxiang Pharmaceutical Co., Ltd were accepted Sulafinil is the first oral multi kinase inhibitor, which is applicable to the treatment of unresectable liver cell carcinoma, advanced renal cell carcinoma and thyroid carcinoma with local recurrence or metastasis, gradual and differentiated type and difficult to treat with radioiodine At present, there are only Bayer's imported drugs in China, and the compound patent expires in 2020 There are many domestic enterprises applying for generic drug listing, among which Chongqing Yaoyou, which has made rapid progress, has been applied by anda in January, and now Tianjiang Xishan pharmaceutical industry is competing with it A number of new generic applications will seize the listed generic market This week's generic drug applications are classified into four categories of new chemicals and three categories of chemicals According to relevant policies, generic drugs declared according to the new registration classification need to be consistent with the quality and efficacy of the original drugs because they are reviewed according to the new classification standards If approved, they will be deemed to have passed the consistency evaluation In this form, these varieties are likely to seize the market of generic drugs which are now on the market in China without consistency evaluation Information source: drug intelligence data, drug intelligence website, official information of Baiji Shenzhou, and public information statement on the Internet: this opinion only represents the author, not the position of drug intelligence website, and you are 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.