Global drug R & D black hole 17 years later, Shanghai Green Valley gv-971 fills

On November 2, 2019, the pharmaceutical industry received the news of approval of "heavyweight" domestic class 1 new drug: the State Drug Administration has conditionally approved the application for listing and registration of ganlute sodium capsule (trade name "nine phase one"), which is used for mild to moderate Alzheimer's disease and improves the recognition function of patients As soon as the news came out, the domestic pharmaceutical industry was boiling, which was also a successful case of Shanghai pilot drug listing license holder system and promoting the rapid listing of innovative research and development achievements In the field of Alzheimer's, known as the black hole of drug research and development, over the past 20 years, major pharmaceutical companies around the world have invested hundreds of billions of dollars in the research and development of new Alzheimer's disease treatment drugs, and more than 320 drugs entering clinical research have failed Mannose sodium, code name "gv-971", trade name: phase 9, 1 ®, jointly developed by Shanghai Institute of medicine, Ocean University of China and Shanghai Green Valley pharmaceutical, is used for mild to moderate Alzheimer's disease and improves patients' cognitive function It is the first time that mannose sodium has been listed on the market in mainland China through the priority review and approval process in the world, which fills the gap that no new drug has been listed in this field for 17 years Picture from green leaf pharmaceutical official website The results show that gv-971 can improve cognitive impairment by remodeling the balance of intestinal flora, inhibiting the abnormal increase of specific metabolites of intestinal flora, reducing peripheral and central inflammation, reducing β - amyloid deposition and tau protein hyperphosphorylation On September 6, 2019, cell research online published nine issues of research results on the mechanism of action of one ® in the treatment of Alzheimer's disease by regulating intestinal flora, which was published as a cover article in the October issue of cell research The article was highly praised by authoritative experts at home and abroad and recommended by Nature magazine A total of 1199 subjects participated in the phase I, phase II and phase III clinical trials The results of a 36 week three-stage clinical study showed that nine stages and one ® can significantly improve the cognitive dysfunction of patients with mild and moderate Alzheimer's disease Compared with placebo group, the main efficacy index cognitive function improved significantly, and the cognitive function scale (ADAS COG) score improved by 2.54 points (P < 0.0001) In addition to the "nine phase one" which is mainly introduced in this paper, the key cooperative development variety of Shanghai Green Valley is "salvianolic acid salt for injection" PS: this variety comes from researcher Wang Yiping (model of the times) of Shanghai Institute of medicine Salvia miltiorrhiza polyphenolate, originated from Salvia miltiorrhiza, is extracted and screened by dozens of Salvia miltiorrhiza compounds Finally, Salvia miltiorrhiza magnesium acetate is the most important medicinal component of Salvia miltiorrhiza Furthermore, Salvia miltiorrhiza magnesium acetate powder injection is developed with Salvia miltiorrhiza magnesium acetate as the quality control standard The indications are coronary heart disease and angina pectoris In 2005, it won the new drug certificate and production approval (Chinese medicine class 2), was listed in the national medical insurance catalogue in 2009, and won the second prize of national technological invention It has been applied in more than 5000 hospitals across the country, with cumulative sales exceeding 25 billion yuan The manufacturer is Shanghai Green Valley Pharmaceutical Co., Ltd At present, after salvianolic acid salt and gv-971, Shanghai Lvgu also jointly applied for CMET antitumor drug "gumetinib", which was developed by Shanghai Pharmaceutical Research Institute and transferred to Lvgu pharmaceutical The clinical application of 1.1 new drug of its API and tablet was approved in March 2016, and then approved in January 2017 after special review Image from: yaozh data In addition to the above varieties, Shanghai Lvgu pharmaceutical also registered and applied for ribavirin capsules, Telmisartan Tablets, metformin hydrochloride capsules, lijiangtang capsules, Danshen injection, omeprazole sodium for injection and other varieties.