Tnp-2092, a class 1 new drug of Danuo medicine, was accepted by CDE

Tnp-2092, a class 1.1 new drug of Danuo Pharmaceutical (Suzhou) Co., Ltd., was undertaken by CDE on April 10 and entered the evaluation center, involving the acceptance numbers of cxhl1500175, cxhl1500176 and cxhl1500177 The drug is the 23rd new class 1.1 drug declared since 2015, which is basically the same as the number of new class 1.1 drugs declared in the same period last year Tnp-2092, a double target molecule, has not been established for a long time It has not been more than two years since 2013 There are three new drug candidates on the R & D line, all of which are double target molecules These new drugs are aimed at the field of digestive tract infection, including Helicobacter pylori infection, Clostridium difficile infection, hepatic encephalopathy, intestinal bacterial overgrowth and Crohn's disease The declared tnp-2092 (patent may be wo2009120789) is a kind of drug against Helicobacter pylori, Clostridium difficile infection and other important gastrointestinal pathogenic bacteria infection, and has completed phase I clinical trial in the United States The other two new drug candidates are tnp-2198 and tnp-2500, which have not been declared Dr Ma Zhenkun, chief scientist of the global TB alliance, is the leader of Dano pharmaceutical in the field of digestive system diseases He has also obtained investment from Tonghe capital, Wuxi apptec, American 2m company and Suzhou Yuanhe holding His intellectual property rights and drug candidates are based on the acquisition of Cumbre and TB alliance has obtained 11 patents More and more new drug R & D companies are focusing on category 1.1 new drugs, but most of them are pursuing hot treatment areas and targets Dano, a company with a large number of competitors, is not a small company, focusing on the digestive system disease field with fewer competitors, and hopes to fundamentally solve the problems of drug resistance in the existing standard triple drug or quadruple drug solutions Dano Pharmaceutical (Suzhou) Co., Ltd., founded in 2013, is located in the Biological Nanotechnology Park of Suzhou Industrial Park It is an innovative biopharmaceutical enterprise specializing in the research, development, production and sales of new drugs for the treatment of gastrointestinal infection Related news: China is a country with high incidence of gastric cancer, and nearly 300000 people die of gastric cancer every year However, due to the high technical threshold, few new drug R & D enterprises declare war on Helicobacter pylori, the culprit of gastric cancer In Suzhou BioBAY, Dano Pharmaceutical (Suzhou) Co., Ltd is one of the "few" enterprises Dano pharmaceutical is an enterprise specialized in the research and development of new drugs of digestive tract diseases, which has a unique double target molecular new drug research and development platform and global protection of intellectual property rights "At present, the first candidate drug of Dano pharmaceutical has completed clinical phase I in the United States, and will enter the clinical phase in China in a year and a half," said Dr Ma Zhenkun, founder and chief executive officer of Dano pharmaceutical Helicobacter pylori infection is the main cause of chronic gastritis, gastric ulcer and gastric cancer The infection rate in China is over 50% "However, such a terrible disease, to a large extent, can not be properly detected and treated," Ma Zhenkun said worriedly "The reason is that the existing treatment scheme is too complicated, the curative effect is poor, the side effects are high, and the burden of patients is too heavy." Local infection of Helicobacter pylori in gastric mucosa In the past, it took a long time to take "triple drugs" or "quadruple drugs" to treat Helicobacter pylori patients These drugs need to be absorbed into the blood circulation system through the system before they can return to the stomach to fight against bacterial infection Only a few drugs played the sterilization role they should play "Not only is the utilization rate of the drug particularly low, but it also has high side effects and organ toxicity With the increasing use of drugs, the drug resistance of bacteria is higher and higher The cure rate of 90% is only about 60% now " In fact, the goal of Dano medicine is to fundamentally solve these problems The key lies in how to overcome the existing drug resistance and reduce the risk of drug resistance in the future "Drugs to their molecular targets are like keys to locks The dilemma of drugs in the past is that one key can open one lock As long as the lock is broken, or gene mutation occurs, the key can't open the lock, thus losing its bactericidal effect." Ma Zhenkun explained, "the dual target technology of Dano medicine is equivalent to one key can open two locks at the same time When the key cannot open one of the locks, another door leading to the sterilization direction can be opened by opening another lock Only when two locks cannot be opened at the same time, i.e two targets mutate at the same time, will the key lose its function, but the probability is very small " Therefore, Dano has developed a series of new drugs with double target molecules, which can not only overcome the existing drug resistance, but also greatly reduce the risk of drug resistance in the future At the same time, these double target molecules have no or only very low systemic absorption After they enter the stomach, they directly act on the site of Helicobacter pylori infection They have high concentration in the digestive tract region and regional antibacterial activity, and also greatly reduce the risk of harm to human organs Ma Zhenkun said that the successful development of these dual target molecules can fundamentally solve the existing problems of Helicobacter pylori treatment, and provide a high therapeutic efficacy, low side effects, convenient use and low cost treatment for patients, so that the elimination of H pylori infection can be eliminated in a large scale, thereby greatly reducing the incidence rate and mortality of gastric cancer Although Danuo pharmaceutical has been established for a short time, its innovative technology has a strong "support group" Its technology platform, intellectual property rights and drug candidates are all provided by the way of technology input by the United States peak biopharmaceuticals At present, Dano pharmaceutical has ten U.S patents, of which the most important three have global patent protection However, for Dano pharmaceutical, a strong technical foundation is only the starting point for innovation and breakthrough At present, from the focus on the digestive system diseases caused by Helicobacter pylori, Dano medicine will extend the research and development of "antennae" to other difficult digestive tract diseases such as hepatic encephalopathy, difficult to distinguish the infection of prismatic bacillus Hepatic encephalopathy is the result of comprehensive action of many factors under the condition of complex metabolism disorder of the body in severe liver disease After research, people found a "key gentleman" of hepatic encephalopathy, blood ammonia Under normal circumstances, the clearance of blood ammonia is mainly due to the formation of urea in the liver, or the formation of glutamine in the brain, liver, kidney and other tissues, which is discharged through the kidney, lung and other tissues "For patients with liver disease, the reduction of liver function will lead to the accumulation of ammonia and other harmful metabolites, leading to hepatic encephalopathy," said Ma Zhenkun "Clinical evidence shows that the growth of harmful metabolites can be inhibited by regulating the intestinal flora structure through drugs, and finally the purpose of treatment can be achieved from the source In recent years, Clostridium difficile infection (CDI) has been a common complication of inpatients and nursing inpatients, and it has an explosive epidemic trend all over the world One of the background of CDI is the abuse of antibiotics, so the treatment of CDI can not simply use antibiotics Ma Zhenkun said that the new drug developed by Danuo medicine can find the target and eliminate Clostridium difficile, so as to improve the cure rate and reduce the side effects In the field of biomedical research and development, ambition alone is not enough, and many "top-notch" innovative talents are needed as the "top-level design" of the research and development team Dano pharmaceutical has established a Scientific Steering Committee led by Dr Wang Xiaodong, director of Beijing Institute of life sciences and academician of the National Academy of Sciences In this committee, Professor Steven McKnight, a famous biochemist in the world, academician of the American Academy of Sciences, chairman of the Department of biochemistry of the Southwestern Medical Center of the United States, world-famous microbiologist, academician of the American Academy of Sciences, rich, Department of molecular and cellular biology of Harvard University Professor losick, Professor Kenneth Chang, a famous gastroenterologist at the University of California Irvine School of medicine and director of the comprehensive digestive disease medical center, will all participate in the research and development of Dano medicine Reprinted by Huang Zigang, editor of Suzhou daily, November 19, 2013