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

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 registration of ganlute sodium capsule (trade name "nine phase one"), which is used for mild to moderate Alzheimer's disease and improves the cognitive 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 Approved variety gv-971 in the field of Alzheimer's is known as the black hole of drug research and development In 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 Image source: https:// research shows that gv-971 can improve cognitive dysfunction 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 egg white 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) Photo source: https:// Shanghai Green Valley Pharmaceutical Co., Ltd was founded in 1997 / headquartered in Zhangjiang Science City, the leading sugar drug R & D and production capacity employees are about 1500 Green Valley Research Institute / academicians / 100 + sugar drug scientists focus on neuropsychology / cancer / cardio cerebrovascular / metabolic diseases / autoimmune diseases The leading technology platform for sugar drug research and development and the original product pipeline have attracted the attention of the government and the media for many times The picture comes from: https:// other varieties developed by Shanghai Green Valley, in addition to the "nine phase one" highlighted in this paper, the key cooperative development variety of Shanghai Green Valley is "Salvia miltiorrhiza polyphenolate 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 Image source: https:// 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 The picture comes from: yaozh data in addition to the above varieties, Shanghai Lvgu pharmaceutical also registered and declared ribavirin capsule, Telmisartan Tablets, metformin hydrochloride capsule, lijiangtang capsule, Danshen injection, omeprazole sodium for injection and other varieties Summary To sum up: gv-971 has made up for the gap in this field in China, and "conditional approval" also reflects the "four strictest" requirements of the latest drug administration law In recent years, the product incubation capacity of Shanghai Pharmaceutical Institute has become stronger and stronger, leading the research and development institutions in both high price transfer and achievement listing capacity Shanghai Green Valley pharmaceutical, relying on the technology of Shanghai Pharmaceutical Institute, has successfully incubated products Ability is also admired by the industry, and this mode is only applicable to a few enterprises I believe that the listing of gv-971 will definitely change the future life of Alzheimer's patients in China! 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