[Zhou Jun] Nobel Prize in medicine - "blood oxygen" relationship reveals a new direction of drug research; Hurun pharmaceutical rich list, Hengrui becomes the most beautiful "baby"; challenges Pfizer's success

This week, we will focus on the drug management law, which will affect tens of millions of heart Nobel Prize in medicine - "blood oxygen" relationship to reveal the new drug research direction Hurun pharmaceutical rich list Hengrui has become the most beautiful "baby" to challenge Pfizer's success! Zhengda Tianqing was again awarded the first Chinese bio pharmaceutical innovation track research and Development Bureau important news drug management law, affecting tens of millions of hearts on the eve of National Day 2019, the National Drug Administration (nmpa) issued the "drug registration management measures" (Revised Draft for comments) This document, which has been reorganized and repositioned for the administration of drug registration in China, will surely pester the registrants and relevant technicians of pharmaceutical enterprises who love learning The measures for the administration of drug registration (Draft for comments) is divided into 11 chapters and 129 articles, covering all aspects of applying for drug listing in China, keeping pace with the latest laws and regulations in multiple fields, and covering the problems existing in reality and ignored in the previous laws and regulations The comprehensive introduction of the drug listing license holder system launched in 2016 can be said to be the core policy change in the drug administration reform in recent years The purpose is to separate the drug registration and holding from the drug production and sales, fully mobilize the enthusiasm of all sectors of society, and realize the optimal allocation of resources The future development of clinical trial management is the key to evaluate whether the drugs to be listed are effective and safe enough, and it is also one of the most expensive work in drug research and development Since July 22, 2015, the drug administration has maintained a continuous high pressure on the compliance inspection of clinical trials It should be said that the standardized management of clinical trials and the authenticity of data have been greatly strengthened and guaranteed The proposed readjustment of drug classification in each drug registration category has been affecting the nerves of drug enterprise registrants, because there is a significant gap in the amount of materials, application process, time and funds required for drug registration in different categories The draft measures for the administration of drug registration not only re describes the classification of chemical drugs, but also re describes the products of traditional Chinese medicine and biological products, showing the possibility of revising the registration classification of traditional Chinese medicine and biological products When we talk about this topic, we must clarify the responsibility of registration verification and GMP certification inspection in the past few years So far: the provincial bureau is mainly responsible for GMP certification and daily inspection of the enterprises under its jurisdiction; the National Bureau is responsible for all kinds of on-site development and production verification, as well as on-site verification and GMP inspection of overseas enterprises The Nobel Prize for medicine in the industry - "blood oxygen" reveals the new direction of drug research Three scientists won the prize for discovering the mechanism by which human cells feel and adapt to different oxygen environments When hypoxia occurs in human body, "hypoxia inducible factor" is activated, which will remind more than 300 genes, or accelerate the generation of red blood cells, or promote the growth of blood vessels, so as to speed up the delivery of oxygen - this is the mechanism of cell hypoxia protection Activate the mechanism of hypoxia protection, accelerate the supply of oxygen, can treat anemia, stroke, sudden heart disease and other diseases caused by hypoxia Inhibiting the mechanism of hypoxia protection and blocking oxygen supply can eliminate cancer cells that also depend on oxygen for survival The first drug to use this mechanism should be the anticancer drug Avastin (bevacizumab), which plays a role by inhibiting the biological activity of human vascular endothelial growth factor (VEGF) It was approved by FDA in 2004 and has been used to treat more than 1 million patients In the past few years, it has been ranked among the top 10 best-selling drugs in the world, with annual sales of US $67 billion According to the official statistics of Hurun, the manufacturing industry is still the most important source of wealth for the entrepreneurs on the list, but the proportion of the number of people dropped to 24.5% from 26.1% last year; real estate is still the second, accounting for 14.8%, basically the same as last year; financial investment is the fourth, accounting for 11.4% from 11.6%; medicine is still the fifth, from 7.1% to 7.6% The pharmaceutical industry has maintained steady growth over the years This year, the number of people on the list is 0.5 percentage points higher than last year, reaching 7.6%, twice that of a decade ago At the same time, for the first time this year, there are entrepreneurs from the pharmaceutical industry in the top 10 Sun piaoyan and Zhong Huijuan, from Hengrui pharmaceutical and Hansen pharmaceutical, ranked fifth in the list with a wealth of 175 billion yuan this year In addition, a total of 129 "pharmaceutical" industry related persons were listed, and the vast majority of them were also famous pharmaceutical enterprises Hengrui, Chinese biology and Yangtze River are all well-known names However, as the only person who has exceeded 100 billion yuan in the list, Hengrui has undoubtedly become the most "beautiful" kid in the whole medical circle With Hansen pharmaceutical listed on the Hong Kong Stock Exchange in June this year, sun piaoyang and Zhong Huijuan, two listed companies, ranked fifth in the top 10 with 175 billion wealth, up 15 places from last year In the first half of this year, Hansen pharmaceutical realized sales revenue of 4.6 billion yuan, an increase of 122% over the same period of last year In the first half of the year, Hengrui pharmaceutical achieved an operating revenue of 10 billion yuan, up 29% year on year "Mr and Mrs sun piaoyang and Zhong Huijuan have created a world No 1 company, and both of them have established a sizable independent enterprise," Hurun said However, what's more amazing is that the company with the largest number of people on the list is also Hengrui No 1 Has Hengrui really become a manufacturing machine for the pharmaceutical rich?? This still does not include sun piaoyang, Zhong Huijuan's couple's Oh!! Shenzhen Stock Exchange of enterprise information: Recently, the listing of Changsheng Biotechnology Co., Ltd was terminated The Shenzhen Stock Exchange announced that on October 8, 2019, the Exchange decided to terminate the listing of Changsheng biotechnology, and entered the delisting period from October 16, 2019 On the next trading day after the expiration of the delisting period, the exchange will delist the company's shares Previously, the listing of Changsheng biological stock was suspended from March 15, 2019 Humanwell medicine: potassium chloride sustained release tablets have been approved by FDA On October 9, humanwell Pharmaceutical Group Co., Ltd (hereinafter referred to as "humanwell pharmaceutical") announced that recently, Yichang humanwell Pharmaceutical Co., Ltd (hereinafter referred to as "Yichang humanwell"), a subsidiary of humanwell pharmaceutical Holding Co., Ltd (hereinafter referred to as "Yichang humanwell") received the approval number of the United States Food and Drug Administration (FDA) on potassium chloride sustained release tablets The reference preparation of potassium chloride sustained-release tablets approved by Yichang humanwell is k-tabextended-releasetables (original research) of abbvie Inc., and the indications are to treat hypokalemia caused by various reasons, such as inadequate feeding, vomiting, severe diarrhea, application of potassium excreting diuretics, hypokalemic familial weekly paralysis, long-term application of glucocorticoids and hyperosmotic glucose supplement Eight billion dollars! Johnson & Johnson Risperdal lost the lawsuit and demanded to pay the sky high compensation, Reuters reported A jury in Philadelphia, Pennsylvania, ruled that Johnson & Johnson should be responsible for the abnormal breast development of Nicholas Murray while taking the Johnson & Johnson antipsychotic Risperdal, and demanded that Johnson & Johnson compensate the patient for 8 billion US dollars Challenge Pfizer successfully! Zhengda Tianqing wins the first track of bio pharmaceutical innovation in China On the evening of October 9, China biopharmaceutical Co., Ltd issued a notice, saying that its holding subsidiary, Zhengda Tianqing Pharmaceutical Group Co., Ltd (hereinafter referred to as "Zhengda Tianqing"), a drug for the treatment of rheumatoid arthritis, has obtained the drug registration approval document issued by the State Drug Administration Statement: this opinion only represents the author, not the position of yaozhi.com, 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.