Opening the door of Chinese medicine again in the new year

Highlights of this week: 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 See the following for more information about drug trials this week: 62 production acceptance numbers (44 varieties) will be submitted this week for review and approval status update The details are as follows: 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 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 capsules (annual statistics) (Note: Statistics of this figure is up to Q1 in 2019) At present, the national bidding price of 12.5mg is 155 yuan, and the bidding price before negotiation is 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 sodium zirconate cyclosilicate powder of AstraZeneca is a hyperkalemia drug, trade name 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 This week, CDE reported 37 new production acceptance numbers (21 varieties), including 1 new drug, 3 imported drugs and 17 generic drugs Details are as follows: Deuterium benzozine (Teva) is a small molecule oral inhibitor targeting VMAT-2 Its indications are 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 Deuterium butylbenzazine 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.