[drug Kajun] Fosun has come to the market of 2.7 billion anti-cancer biological analogues, 3 billion grade products have passed the consistency evaluation, and the first-line oral generic drug of rare Gaucher disease has been put on the market
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Last Update: 2019-05-06
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Source: Internet
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Author: User
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Highlights: 1 The first-line oral drug of rare Gaucher's disease accelerated its listing; 2 The application for import of Fuxing and YANGSEN heavy drug products is proposed to be included in the priority review; 3 Fuhong Hanlin is the first anti-cancer star drug "Herceptin" biological similar drug in China to be listed; 4 The drug has passed the consistency evaluation, with 300 million grade products; 5 Zhongsheng Pharmaceutical Co., Ltd is a class I innovative drug for the treatment of influenza A, and the small RNA polymerase inhibitor has completed phase I clinical treatment; 6 Jingfeng pharmaceutical has won an anda market of 17 million US dollars This week (April 29 May 5), three drugs are to be included in the priority review, two of which are imported drugs and one is generic drugs On April 30, Fosun Pharmaceutical's application for the import of avatripopa tablets declared by Fosun Pharmaceutical is to be included in the priority review after being publicized by CDE Thrombocytopenia (CLDT) is mainly used in adult patients with chronic liver disease who are scheduled for diagnostic operation or operation In March 2018, Fosun Pharmaceutical obtained the license from akarx, Inc on the exclusive sales agency rights (including exclusive registration and development rights for sales) of the new drug in mainland China and Hong Kong SAR, and akarx is still the obligee of the new drug in the region Avatrappar tablets on the market all over the world are only doplet of akarx, and there is no similar product of the new drug on the market in China According to iqviamid ASTM data, doplet's global sales in 2018 were about $1.27 million In addition, Fosun also has a class 2.4 clinical application under review, which is mainly used for thrombocytopenia (CIT) caused by tumor chemotherapy Kailai Tiancheng medicine eligelusta capsule eligelusta capsule is the world's first oral drug for the treatment of Gaucher's disease It is suitable for the long-term treatment of adult patients with liver drug metabolizing enzyme cytochrome P4502D6 (CYP2D6) metabolizing genotype as weak metabolizing, medium metabolizing and fast metabolizing type 1 It is not suitable for a small number of patients with faster metabolizing or uncertain metabolizing speed confirmed by gene test (CYP2D6) It is the first-line oral drug for the treatment of geriatric disease Eliglostat was developed by Genzyme (now under Sanofi) and approved by the US Food and Drug Administration (FDA) on August 19, 2014 In January 2015, the drug was approved by EMA, and the trade name is cerdelga At present, the original research drug has not been listed in China, and Kailai Tiancheng pharmaceutical is expected to take the first imitation of eligrostal capsule Apalumide, a new generation of oral androgen receptor inhibitor, was developed by Johnson & Johnson and marketed in February 2018 It is a new generation of oral androgen receptor inhibitor for the treatment of non metastatic castration resistant prostate cancer Because androgen plays an important role in the development of prostate cancer, inhibiting androgen receptor can control the growth of prostate cancer, and then alleviate the disease The drug has also become the first FDA approved drug for the treatment of non metastatic castration resistant prostate cancer This week, the number of CDE new acceptance reports reached 16, including one for new drugs, five for imported drugs, involving two varieties, and the rest for generic drugs On April 29, Fuhong Hanlin's application for the listing of trastuzumab for injection was accepted by CDE Trastuzumab for injection is a monoclonal antibody bioequivalent drug independently developed by Fosun medicine, which is mainly used for indications of metastatic breast cancer and gastric cancer As of April 25, the indications of this product for breast cancer treatment were in phase III clinical trials in China (excluding Hong Kong, Macao and Taiwan, the same below), Ukraine, Poland, Philippines and other countries As of March 2019, Fosun Group has invested about RMB 546 million 340 thousand (Unaudited) in the R & D of the new drug (including indications for metastatic breast cancer and gastric cancer) At present, trastuzumab injection on the market in China is Herceptin ® of Roche According to iqviachpa, the sales volume of Herceptin ® in China in 2018 is about 2.7 billion yuan On April 28, the import application of wibutuximab for injection declared by Takeda was accepted The commercial name of ibuproximab (adcetris) is Takeda and Seattle genetics, The anti-CD30 antibody drug conjugate developed jointly by Inc can specifically bind the CD30 antigen of tumor cells with the antibody component "butuximab (CD30 monoclonal antibody)", which is similar to the "biological missile" that precisely transports the coupled anti microtubule chemotherapy drug (MMAE, monomethylorestatin) to the tumor to play a precise anti-cancer role The drug was approved in the United States for the treatment of Hodgkin's lymphoma (HL) and systemic anaplastic large cell lymphoma (salcl) On April 30, Nanjing Hengsheng Pharmaceutical Co., Ltd.'s generic application for carbonation siram tablet was accepted, which was used for the treatment of hyperphosphatemia in patients with chronic kidney disease A phosphoric acid binding polymer developed by Genzyme was first approved by the FDA on October 30, 1998 (trade name Renagel), while renvela, the trade name of carbonate, obtained the passes for the markets of the United States and the European Union on July 19, 2007 and June 21, 2009 At present, the drug has been listed in more than 80 countries around the world At present, there are only four kinds of applications of Hengsheng pharmaceutical and the old six kinds of applications of Tianjin Pacific pharmaceutical, which are only imported by domestic manufacturers and apply for generic drug listing On April 29, the application for listing of the generic drug of tovaptan tablet declared by Hengrui pharmaceutical was accepted The indications of the drug are clinically significant hyponatremia of high blood volume and normal blood volume [patients whose serum sodium content is less than or equal to 125meq / L or whose hyponatremia cannot be changed after restriction of water intake], including patients with heart failure, cirrhosis and antidiuretic hormone secretion syndrome Tovaptan was developed by Otsuka pharmaceutical It was first approved by the US Food and Drug Administration (FDA) on May 19, 2009, then approved by the European Drug Administration (EMA) on August 3, 2009, and approved by the Japanese pharmaceutical medical device integration Agency (PMDA) on October 27, 2010 The product name is samsca At present, only Zhejiang Otsuka Pharmaceutical Co., Ltd holds the production approval Hot enterprises announced that the fourth metformin hydrochloride tablet of Shanghai Pharmaceutical passed the consistency evaluation On April 30, Shanghai Pharmaceutical Group Co., Ltd announced that its wholly-owned subsidiary, Shanghai Xinyi balance Pharmaceutical Co., Ltd., had become the fourth evaluated enterprise (another three evaluated Enterprises: Beijing Sihuan Pharmaceutical Co., Ltd., Guangdong South China Pharmaceutical Group, Guizhou Tian'an Pharmaceutical Co., Ltd.) through the consistency evaluation of quality and efficacy of generic drugs As of the announcement date, Shanghai Pharmaceutical has invested about 6.18 million yuan in the R & D cost for the consistency evaluation of the drug In 2018, Xinyi balance achieved sales revenue of RMB 15.82 million Metformin hydrochloride tablets are mainly used for the treatment of type 2 diabetes They were developed by Japan new drug Co., Ltd and first listed in Japan in 1961 According to the domestic drug database of pharmaceutical intelligence, at present, 113 domestic enterprises hold the production approval documents of the drug, 27 enterprises apply for conformity evaluation, and now 4 enterprises have passed the evaluation According to iqvia1 data, the hospital purchase amount of the drug in 2018 was 186 million yuan On April 30, the fourth CR Shuanghe metformin hydrochloride sustained-release tablet passed the consistency evaluation CR Shuanghe Pharmaceutical Co., Ltd issued a notice saying that the metformin hydrochloride sustained-release tablet of its wholly-owned subsidiary Beijing Wanhui Shuanghe Pharmaceutical Co., Ltd passed the consistency evaluation of quality and efficacy of generic drugs Become the fourth evaluated enterprise (another 3 evaluated Enterprises: Jiangsu Deyuan pharmaceutical, yuekang Pharmaceutical Group, Shanghai Shangyao Xinyi) Since the consistency evaluation of Wanhui Shuanghe, the cumulative R & D investment has been RMB 13878900 (Unaudited) Metformin hydrochloride sustained-release tablets as a separate treatment, it is recommended to combine diet and exercise therapy, to achieve the control of blood glucose in type 2 diabetes The drug can be used in combination with sulfonylureas or insulin to control blood sugar in adults Metformin hydrochloride sustained-release tablets were listed in the United States in 2000, with the trade name of "glucophagexr ®" The original manufacturer was Merck sero limited In the international market, the sales volume of metformin hydrochloride sustained-release tablets in 2017 was USD 1.739 billion According to the pharmaceutical intelligence data, 46 domestic enterprises hold production approval documents, 11 enterprises apply for conformity assessment, and 4 enterprises have passed the conformity assessment through supplementary application According to IMS data, in 2018, the national sales volume of metformin hydrochloride sustained-release tablets was 457 million yuan; the top five enterprises were Chongqing kangkeri Pharmaceutical Co., Ltd 22.29%, Qingdao Huanghai Pharmaceutical Co., Ltd 19.57%, Zhengda Tianqing Pharmaceutical Group 11.81%, Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd 6.61%, Jiangsu Deyuan Pharmaceutical Co., Ltd 6.10% The sales revenue of Wanhui Shuanghe metformin hydrochloride sustained release tablets accounts for 4.09% of the national sales On April 29th, Jiangsu Wuzhong Industry Co., Ltd issued a notice that its wholly-owned subsidiary, Jiangsu Wuzhong Pharmaceutical Group Co., Ltd., a subsidiary of Jiangsu Wuzhong Pharmaceutical Group Co., Ltd., has passed the consistency evaluation of quality and efficacy of generic drugs As of the announcement date, the company has invested a total R & D cost of about 8.01 million yuan in the trimetazidine hydrochloride tablet project Trimetazidine hydrochloride tablets, as an additional drug, are used for the symptomatic treatment of adult patients with stable angina pectoris who are poorly controlled or intolerable in the first-line anti angina treatment It was first developed by Servier and listed on the market in France It is a common tablet It is used as an additional therapy in adults for symptomatic treatment of stable angina patients with poor or intolerable first-line anti angina therapy It was approved to be listed in China in 2000 At present, 11 domestic enterprises hold domestic approval documents for trimetazidine hydrochloride tablets, 3 enterprises apply for consistency evaluation, and Jiangsu Wuzhong industry is the first one to have been evaluated According to IMS sales database, the global sales volume of trimetazidine hydrochloride tablets (including other dosage forms) in 2018 is about $393 million, and the sales volume in China is about $127 million On April 30, Fujian guangshengtang Pharmaceutical Co., Ltd issued a notice that its adefovir dipivoxil tablets passed the consistency evaluation of quality and efficacy of generic drugs Adefovir dipivoxil is the best combination of lamivudine, telbivudine or entecavir Adefovir dipivoxil is the precursor of adefovir It is hydrolyzed to adefovir in vivo to play an antiviral role It is a nucleoside (acid) anti hepatitis B drug It is suitable for the treatment of adult chronic hepatitis B patients with evidence of hepatitis B virus active replication, accompanied by continuous elevation of serum amino acid transferase (ALT or AST) or liver histological active lesions At present, 16 domestic enterprises hold production approval documents, 3 enterprises apply for conformity evaluation, and 2 enterprises of Qilu and guangshengtang have been evaluated Recently, Zhongsheng Pharmaceutical Co., Ltd announced that its holding subsidiary Guangdong Zhongsheng RuiChuang Biotechnology Co., Ltd was used to prevent and treat influenza A and human avian influenza
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