[Yao Kejun] in the new year's battle, the first domestic listed product was born! A number of first domestic heavy-duty anticancer drugs have been approved; Hengrui, Watson biology, Shiyao

This week's highlights: zaiding pharmaceutical was approved to be the first product in mainland China; the first osmotic pump controlled-release metformin drug sold in China and the United States was listed in China; another copy of stone drug was obtained, and sunitinib malate capsule was launched; new drugs were urgently needed for rare diseases, and the first deuterium drug in the world was listed in China At the same time, this product is the second approved PARP inhibitor in China, the first domestic recombinant human papillomavirus vaccine, the first domestic 13 valent pneumococcal polysaccharide conjugate vaccine, and the first innovative anesthetics for injection of Hengrui medicine In addition, gv-971, an original Alzheimer's disease drug, was officially launched and sold in DTP pharmacies in China Please refer to the following for more drug review trends this week: new trends of nmpa review and approval status update of 62 production acceptance numbers (44 varieties) of this week; details are as follows: metformin hydrochloride sustained release tablets Baiyang pharmaceutical is a newly approved metformin in China Its full name is metformin hydrochloride sustained-release tablets (Ⅲ) Nida It is the first osmotic pump controlled-release metformin drug sold in China and the United States The drug adopts osmotic pump controlled-release preparation technology, which makes the drug release in the body at a constant speed, and the blood drug concentration is stable Only once a day, it can effectively control blood sugar, bringing convenience and new options for Chinese type 2 diabetes patients Metformin plays a very important role in the clinical treatment of type 2 diabetes At present, it is the first choice, effective and irreplaceable antidiabetic drug From the perspective of market structure alone, there are many manufacturers of metformin, but at present, Squibb, the original research enterprise, still occupies the main market In 2018, more than 50% of the market share of domestic sample hospitals was occupied by the original research enterprise, with sales of 319 million yuan According to the pharmaceutical intelligence data, there are 58 enterprises applying for the consistency evaluation of metformin hydrochloride tablets at present, and more than 10 enterprises having been evaluated The market competition is particularly fierce Baiyang pharmaceutical's osmotic pump metformin is declared as a Class 3 new drug in China, and it is deemed to pass the consistency evaluation after being approved The diabetes market in the United States is dominated by slow and controlled-release dosage forms, with a market share of 94% As Baiyang pharmaceutical Neda is selling well in the United States, the original research product has been delisted in the United States According to Baiyang pharmaceutical, the price of Neda 60 Tablets / bottle specification is about 2100 US dollars in the United States, and the price of the product listed in China may be only 1% of the original research drug's market price in the United States Baiyang pharmaceutical's osmotic pump metformin is listed on the market, which greatly impacts the domestic metformin market, and is expected to change the monopoly situation of diabetes market of large international pharmaceutical companies Sunitinib malate capsule is a small multi-target receptor tyrosine kinase (RTKs) inhibitor, which has multiple functions of inhibiting tumor angiogenesis and tumor cell growth and metastasis The drug is used to treat gastrointestinal stromal tumor (GIST), advanced renal cell carcinoma (RCC) and pancreatic neuroendocrine tumor (PNET) Sunitinib malate was originally developed and produced by Pfizer, which was approved by FDA on January 26, 2006, and approved by EMA on July of the same year It entered China in 2007, with the Chinese trade name of sotan According to the sales data mining system of pharmaceutical intelligence data hospital, at present, there is only the original sunitinib malate Capsule on the market in China, which was included in the medical insurance after the negotiation of anti-cancer drug medical insurance in 2018, with a year-on-year increase of 53.8% 2016-2019 - sales time analysis of sunitinib malate capsule (annual statistics) (Note: the statistics of this figure are as of Q1 2019) Currently, the national bidding price of 12.5mg is 155 yuan, and the bidding price before the negotiation is about 438.16 yuan, a decrease of nearly 65% According to the pharmaceutical intelligence database, there are 11 enterprises in China currently engaged in the research and development of sunitinib malate, 9 of which are in the process of listing applications According to the status of enterprises in nmpa, it is expected that Zhengda Tianqing will become the second generic drug to take sunitinib malate capsule The approved product is lokelma, which is a highly selective oral potassium remover Originally developed by zspharma, it was acquired by AstraZeneca to obtain the development right of this potentially heavy drug Lokelma was approved by the European Commission in March 2018 and the US FDA in May 2018 for the treatment of adult patients with hyperkalemia In May this year, sodium zirconate cyclosilicate powder was included in the list of the second batch of clinically urgent overseas new drugs There are 37 new CDE production acceptance numbers (21 varieties) in this week's review and approval, including 1 new drug, 3 imported drugs and 17 generic drugs The details are as follows: deuteraterabenzine (Teva) is a kind of targeted VMAT-2 (veterinary monoamine transporter) 2) The indications of these inhibitors were tardive dyskinesia and Huntington's chorea Approved by the US FDA on April 3, 2017 for the treatment of Huntington's disease, it is the first deuterium drug approved by the FDA for marketing Deuterobutylbenzazine tablets were selected into the first batch of clinically urgent overseas new drugs list of CDE in China (released by CDE on November 1, 2018) According to the national attention to rare diseases, with the speed of the current drug review of rare diseases, DBB should soon enter the Chinese market Domestic enterprises in the development of deuterium drugs include: Zejing biology, Chengdu Haichuang pharmaceutical, yuanyuankang, etc Data source: drug intelligence data, enterprise announcement and other online public data information source: drug intelligence data, enterprise announcement and other online public information With high integration, in-depth analysis and intelligent intelligence of pharmaceutical intelligence data, the intelligent tool platform for pharmaceutical data has been specially built for VIP enterprise customers, covering core data such as drug registration, hospital sales, drug reports, enterprise reports, clinical trials, drug listing, drug bid winning, device listing, drug sales, etc., and providing all-round access to enterprise users from production, research and development, sales, and use And other information channels in various links to help enterprises in R & D and decision-making Mengmeng statement: this view only represents the author and does not represent the position of yaozhi.com 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.