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Breaking the monopoly pattern of 60 billion chemical drugs, the field of diabetes ushered in the first chinese medicine new drugs; the first imitation of the first multi-field, hepatitis C, anticoagulant field, rare diseases and other original research monopoly ushered in the impact; Norcheng Jianhua 1 new drug Obitini 2 adaptation to submit a listing application; stone medicine Oi Apster tablets, leading the original research, the first domestic newspaper productionreview and approval of new developments
March 13 to March 20 NMPA approval speed accelerated, of which the main approved drugs are: 2 domestic 1 class of new drugs, 1 new Chinese medicine, 3 different areas of heavy-duty drug first imitation, as follows:2 domestic 1 New drugmetasultine amate: the world's second third-generation EGFR-TKI innovation, and the world's first medium progression-free survival (mPFS) for more than 1 year (second-line use) of the three generations of EGFR-TKIUnsurprisingly, this week Howson Pharmaceuticals' innovative drug was approvedthis time, the approval of the amera ® (ametinib tablets) of Haussen Pharmaceuticals has been approved to provide clinicians with a new and effective, safe and available option to provide long-term, high-quality survival for more patients with advanced non-small cell lung cancer (NSCLC)benzene-ring ammonium bromide nasal spray: Is a new type 1.1 drug independently developed by Yingu Pharmaceuticals, is the first synthesis of a new international leading, high-selectivity M choline receptor antagonists, included in the Beijing Municipal Science and Technology Commission major tender topicMoreover, benzene ring ammonium bromide nasal spray toxic side effects are low, safe to use, applicable to a wide range of people, with a huge market prospects1 new Chinese medicine: Sanzhi Total Alkaloid tablets(the first new chinese medicine for diabetes in the last 10 years)Beijing Wu and Boao Pharmaceuticals 5 new drugs Sanzhi Total alkaloid tablets have been approved for the treatment of type 2 diabetesCompared with the internationally recognized chemical medicine (Akapo sugar) or with traditional Chinese medicine crude formulations, sanzhi alkaloids have a clear competitive advantage in the marketcompared with traditional Chinese medicine, it broke through the defects of unclear foundation, uncontrollable mass, inaccurate efficacy and no quantitative effectcompared with chemical drugs, make up for the long-term use of single-target drugs there are safety risks of the short boardThe mechanism of action of mulberry total alkaloid tablets is similar to that of Acapo sugar, II, III clinical is led by Beijing Concord Hospital, more than 30 Chinese and Western medical clinical institutions participate, with "chemical medicine" Acapo sugar as a positive control, "glycated hemoglobin" as a clinical evaluation of the efficacy index, the results show that the two can significantly reduce the efficacy of sugar, long-term use can significantly reduce fasting and post-meal blood sugar, but also effectively control "sugardata show that in 2018, the total sales of diabetes drugs 62.32 billion yuan, of which the sales of diabetes drugs 60.62 billion yuan The approval of the drug will change the oral sugar-reducing drug market has been dominated by chemical drugs Wuando Pharmaceuticals said that Sanzhi total alkaloid tablets are to create independent innovation of natural heavy drugs, once successfully developed, as an exclusive patented products, up to the annual sales of the post-partum is expected to exceed 1 billion yuan 3 blockbusters were born, the original research monopoly ushered in the impact of the -forward Neal the forefront of the drug is a forefront of the development of United Therapeutics, in April 2013, was approved for import in China, was China's "drug king", in 2015-2016 its maximum dose (20ml:200mg) with a high price of 99900 yuan / stake in the registration declaration, foreign enterprises Qu fore-nayl declaration number, domestic enterprises only zhaoke pharmaceutical enterprises carried out a generic drug listing application sophophosphate bubetablets sophosofbwe tablets, also known as "Ji generation", is a direct antiviral drug developed by Gilead (DAA), has been 4 generations, are approved in the domestic market At present, China's HCV (hepatitis C virus) antiviral market is almost monopolized by foreign enterprises days ago, A DAA drug, The Colopervir capsule, has been approved by NMPA in conjunction with sorphophobwe for the treatment of chronic HCV patients with primary or interferon treatment genes 1, 2, 3, 6 This time won the first imitation of the sophophobo bwe tablets, "combination fist" accelerated its layout in the field of hepatitis C pharmaceutical data show that at present, there are three other enterprises are in the market of sophobo- Dabigaster is the first new oral anticoagulant drug to be launched in 50 years, following the classic anticoagulant drug warfarin, and is a landmark development by Theburgin Ingeheim, Germany Domestic anti-thrombosis market size of more than 30 billion yuan, this is the day clear to take the first imitation of Darbygar group esters, will further consolidate the competitive advantage in the anti-coagulation market New acceptance for review and approval CDE new production acceptance number 31 (25 varieties), of which Noshen Jianhua Obutoni re-submitted new indications; stone medicine Oi Apster tablets, the first domestic production, more dynamics, details as follows: Obutoni Obutoni is a special lysing BTK inhibitor, independently developed by the Norsan Jianhua team, used to treat tumors and autoimmune diseases, access to major national support Currently, three BTK inhibitors have been approved worldwide: Ibutini of Johnson and Johnson, Akatini in AstraZeneca and Zebtini in Baiji Shenzhou this is the second application for a new drug to be accepted by the State Drug Administration for the treatment of patients with recurrent/difficult-treatment set of cell lymphoma (MCL) Previously, the NDA for the treatment of CLL/SLL patients was accepted by the NMPA in November 2019 and was included in the priority review in January 2020 currently, in addition to the above-mentioned ndA indications, Obbutini is also in China for recurrent/ difficult to treat marginal lymphoma (MZL), recurrent/difficult to treat central nervous system lymphoma (CNSL), relapse/difficult to treat Huahua cyloprotein globulin globulin (WM), relapse/difficult to treat CD20-B cell lymphoma, relapse/difficult to treat diffuse large B cell lymphoma (DLB) and systemic leukaemia (DLB) Apster film
Apster film (product name: Otezla) was developed by the United States New Base, launched in the United States in 2014, is currently approved for three indications: for the treatment of adult active psoriasis arthritis (PsA), for moderate to severe plaque psoriasis and for the treatment of Behchct disease-related mouth ulcers Full-year 2018 sales reached $1.608 billion data show that the original drug Otezla did not enter China Stone pharmaceutical group Apster tablets for the first domestic newspaper listing, is expected to lead the original research listed to win the first imitation in China At present, there are 25 enterprises to carry out the generic drug research, 9 enterprises have entered the clinical trial stage clinical trial stage enterprise screenshots data source: pharmaceutical data, corporate announcements and other network public data sources of information: pharmaceutical data, corporate announcements and other network public information the original title: "Pharmaceutical Curry Jun" heavy Chinese medicine impact 60 billion drug sugar market! Multi-field first imitation was born, the original research monopoly broke in that;