Improved new drug project template drug.

Recently, we are all in a variety of collection network winning bid, a variety of tall new target drugs, monoanti-drugs, cell therapy drugs research and development progress in turn bombardedWill genericdrugs be drowned out by a flood of innovative drugs on the high board? Will companies without a solid base be completely cut off from the research and development circle of innovative drugs? Today, we take stock of a batch of chemicals that are really clinically oriented and cleverly designed to go on sale in JapanIf these species are now imitation just in time for a high probability that they can be separated from the Collection of the Red Sea but not out of the clinical large indications field market space can beIn addition, we can also learn from its design and research ideas to do the development of new drug active ingredients listed as a new drug, optimize the structure to reduce serious adverse reactions, based on clinical pre-existing demand for drug preparations, etcare the way to goThe development of new drugs for chemical modification is usually based on clear clinical needs and improvement directions based on the active ingredients already on the marketCompared with the low cost of research and development of innovative drugs (high probability of simplifying the content of preclinical pharmacological toxicology), the short research and development cycle and the high success rate of the clinical research target sit until it is of great social significance and clinical valueYou can carefully interpret the "Chemical-improved new drug clinical trial technical guidelines (draft for comments) issued by the National Bureau of Drug Review Center in the coming yearMint brain oral solution Mint brain oral solution main ingredient menthol original research plant for the variety in Japan in the year listed commodity named for upper gastrointestinal endoscopy and treatment inhibited gastrointestinal peristalsisThe picture comes from the official website this product packaging is pre-filled in the form of the drug-giving route through the endoscope jaw to the gastric vents spread effectively reduce gastrointestinal peristalsis not only reduce patient suffering and facilitate doctors to observe to improve the effectiveness of diagnosis and treatmentComparative clinical trials showed that the upper gastrointestinal peristaltics in clinical trials of upper gastrointestinal endoscopy therapy were given to a placebo group of mild (degree) orlessIn addition, the average duration of mild gastrointestinal peristalsis in patients in this trial was seconds less than secondsThe upper digestive tract endoscope examination has been widely popular in our countryUpper gastrointestinal endoscopy on upper gastrointestinal bleeding is the preferred check measure and can be treated with endoscopy at the same timeEndoscopy diagnosis is more accurate and sensitive for superficial ulcersEndoscopy is more helpful in the detection of early lesions in the upper digestive tract can significantly improve the detection rate of early detection of upper digestive tract tumors and therefore also used in the natural population censusAt present, the domestic market has not yet the same type (the mode of administration, mechanism of action, the same efficacy) of the drug market in the current gastroenteroscopy is very common has been as a routine physical examination project today the variety must have a foothold Domestic current listing declaration status of the year original research company in the domestic application for import year approved clinical trial year completed clinical trial annual report is currently under review Another Jinan Baino Pharmaceutical Technology Development Co , Ltd annual declaration of the variety year approved clinical year Chengdu Dikang Pharmaceutical Co., Ltd to carry out in the healthy subjects of the human pharmacokinetictest test has not yet made progress At present, the original research has completed the clinical research report declaration in the current generic drug research and development declaration is the first imitation of oral solution agent on the market at the time save time and effort you understand In addition, the variety is also a typical case of listed pharmaceutical active ingredients to develop new indications no discovery of synthetic new compounds of the difficult without complex pre-clinical research and development risks and costs to reduce the market expectations and revenue rise Spherical activated carbon particles Commodity name activated ingredients: asphalt-based spherical activated carbon (described in the original Japanese research specification: oil hydrocarbons from the spherical particle porous carbon at high temperature oxidation and reduction treatment of spherical adsorption carbon) Year in Japan listed particle pack; capsule capsule year listed crash tablets Indications: Chronic renal insufficiency and uremia are used to delay the start time of dialysis in patients with chronic renal failure and to improve the symptoms of uremia in patients with chronic renal failure Original research manufacturer: Japan WuYu Chemical has now been renamed Mitsubishi Tianbian Pharmaceuticals The species has adsorption-based spherical particles with a diameter of the black spherical particles filled with many nano-size () hole-in-hole products by adsorption of urea toxin seromilen toxin in the gastrointestinal tract of patients with renal failure patients to improve serum creatinine removal rate, urea nitrogen content delays chronic renal failure patients to start hemodialysis time to improve patients' uremia symptoms The difference between this product and ordinary activated carbon in addition to the large amount of toxin adsorption also has a small amount of adsorption to digestive enzymes in the gastrointestinal tract significantly reduced the incidence of constipation (1) Particulate agent (2) rapid collapse of the product since the annual listing of the product has been steadily climbing to maintain the annual growth rate since the annual sales of the variety in Japan exceeded 100 million yen after the sales of the variety has been maintained at a peak annual sales of about 100 million yen is more than 100 million yen It's rare for an old breed that's been on the market for more than 20 years Effective treatment for patients with chronic renal failure is the annual medical cost of renal dialysis for governments and individuals Spherical activated carbon can effectively relieve the symptoms of chronic renal failure patients delay the introduction of dialysis to improve the quality of life of patients in addition to reducing the government and individual economic expenses of patients this is the best of the variety The variety is currently not in the domestic declared active period of manufacturers only Shanghai Rheanda Investment Management Co , Ltd has declared the variety and made no follow-up progress in clinical approval From the perspective of generic drug development, the variety for the adaptive population has a bright sales and domestic non-imitation non-concern hot varieties worth a look In addition, the species belongs to the typical structural optimization success case through new technology to distinguish it from ordinary activated carbon value doubled the clinical value and clinical significance Artificial cerebrospinal fluid image from the official website of Otsuka Pharmaceutical Factory Japanese-language products called the レ ridge hand-washed irrigation fluid type dose: solution agent bag This variety consists of two parts when the upper and lower mixing first part: the volume is glucose and electrolyte solution value about () the second part: the volume is the electrolyte solution value about () Indications: The cleansing of spinal cord disorders and the perfusion of endoscopy surgery for craniofacial surgery Original research company: Otsuka Pharmaceutical Factory The variety was launched in Japan in January The perfusion fluids used in cranial surgery at home and abroad were found at present, including physiological saline, lactic acid Ringer solution and artificial cerebrospinal fluid () The artificial cerebrospinal fluid currently used in clinical use is a standard configuration environment that is not configured by the hospital itself, and the relatively complex clinical use of the process is highly risky and inconvenient According to the search and query related literature, the clinical brain treatment of artificial cerebrospinal fluid in China includes intracranial infection, ventricular hemorrhage, meningitis, traumatic intracranial treatment, intracranial tumor removal, cobweb subcavity hemorrhage, etc Domestic studies have shown that artificial cerebrospinal fluid is used in brain surgery irrigation surgery and the patient's prognosis is better than physiological saline can significantly reduce the re-damage to brain tissue brought about by physiological saline replacement can also reduce the incidence of postoperative cerebral edema Artificial cerebrospinal fluid for intracranial infection and meningitis cerebrospinal fluid replacement and intrauterine band medicine also have better effect than physiological saline and intravenous administration The greatest advantage of this variety is that there is a clinical application basis and there is clinical need for its use in brain surgery at home and abroad have been studied and recognized and the doctor's point of view is that the clinical effect of this product is better than the current mainstream application of physiological saline finished drug form market (except Japan) may be the biggest factor limiting its use Overall, it is a drug worthy of further promotion and application In addition, from the point of view of new drug development, the species belongs to the variety found on the basis of existing clinical applications and needs The project of this new drug is closely linked to clinical needs in line with today's needs for new drug development follow-up clinical trial risk is also greatly reduced Strong large enterprises can take a new innovative drugs, trend of biological drugs, cutting-edge cell medicine research and development Small and medium-sized enterprises and research and development enterprises with their own expertise and characteristics can take the path of research and development of new drugs with the characteristics of generic drugs and there is clinical need Blossoms in full bloom, each has the direction of the healthy development of the pharmaceutical industry is also for the current country for pharmaceutical research and development to be clinical-oriented positive response