Improved new drug project template drug.

Text . . . Wen xiaofish recently we are in a variety of collection of hanging net winning bid, a variety of tall new target drugs, monoanti-drugs, cell therapy drugs research and development progress in turn bombing.
generics will be drowned out by a flood of innovative drugs? Will companies without a solid base be completely cut off from the research and development circle of innovative drugs? Today, we will take stock of a number of real clinical needs-oriented, and cleverly designed chemicals listed in Japan.
if these varieties are now imitation, just at the right time, the high probability can be separated from the collection of the Red Sea but not out of the field of clinical large-scale indications, market space can be expected.
in addition, we can also learn from its design and research and development ideas to do improved new drugs, the marketed drug active ingredient new indication development, optimize API structure to reduce serious adverse reactions, based on clinical lysage-based drug preparations are all the way to go. The development of new drugs
improved chemicals is usually based on the active ingredients already on the market, with clear clinical needs and improvement directions. Compared with innovative drugs, the
has low research and development costs (high probability to simplify the contents of preclinical pharmacological toxicology), the short research and development cycle, and the high success rate of clear and clear clinical research objectives, which has important social significance and clinical value.
you can carefully interpret the "Technical Guidelines for Clinical Trials of Chemical Lycing New Drugs" issued by the National Bureau of Drug Review Center in June 2020, and the road is in the way.
mint brain oral solution mint brain oral solution, the main ingredient L-menthol, the original manufacturer of Nihon Pharmaceutical, the original manufacturer of nihon Pharmaceutical, in December 2010 in Japan, the product is called Minclea, used in upper gastrointestinal endoscopy and treatment to suppress gastrointestinal peristalsis.
picture comes from the Nihon Pharmaceutical official website packaging is pre-filled form, the drug route through the endoscope jaw to the gastric ventorts spread, effectively reduce gastrointestinal peristalsis, not only reduce patient suffering, but also facilitate doctor observation, improve the effectiveness of diagnosis and treatment.
comparative clinical trials showed that gastrointestinal peristalsis was mild (2 degrees) below mild (2 degrees) in clinical trials of upper gastrointestinal endoscopy therapy, 85.4% in this group and 39.0% in the placebo group.
, the average duration of mild gastrointestinal peristalsis in patients in this trial was 1840 seconds, compared with 1340 seconds for the placebo group.
the upper gastrointestinal endoscope examination has been widely popular in our country.
upper gastrointestinal endoscopy is the preferred check measure for upper gastrointestinal bleeding, and can be accompanied by endoscopic hemorrhage therapy.
endoscopic diagnosis is more accurate and sensitive for superficial ulcers.
endoscopy is more conducive to the detection of early lesions in the upper digestive tract, can significantly improve the detection rate of early detection of tumors in the upper digestive tract, and therefore also used in the natural population census.
the current domestic market has not yet the same type of drugs (the mode of administration, mechanism of action, the same efficacy) of the drug market, in the current gastroenteroscopy is very common has been used as a routine medical examination project today, the variety is bound to have a foothold.
the current status quo of domestic listing declaration in 2012 the original research company applied for import sin, approved in 2015 clinical, completed clinical trials in 2018, october 2019 reported, is currently under review.
also Jinan Baino Pharmaceutical Technology Development Co., Ltd. declared the variety in December 2013, was approved for clinical in 2016, 2018 Chengdu Dikang Pharmaceutical Co., Ltd. to carry out in-health subjects in the human body pharmacokinetics test, there is no progress.
the current original research has completed clinical research reporting declaration, now generic drug research and development declaration is just right, 4 types of oral solution agent first imitation market save time and effort, you understand.
in addition, the species is also a typical case of the development of new indications of the listed pharmaceutical active ingredients, no difficulty in finding new compounds, no complex preclinical research, development risks and cost reduction, market expectations and rising revenue.
the spherical activated carbon particle commodity name Kremezin, the active ingredient: asphalt-based spherical activated carbon (described in the original Japanese research specification: oil hydrocarbons from the spherical particle porous carbon, in high temperature oxidation and reduction treatment of spherical adsorption carbon).
listed in Japan in 1991 particles 2g/pack; capsules 200mg/grain, 2017 listed 500mg/chip.
indications: chronic renal insufficiency and uremia, the effect is to delay the start time of dialysis in patients with chronic renal failure and improve the uremia symptoms of patients with chronic renal failure.
original research manufacturers: Japan WuYu Chemical, has now been renamed Mitsubishi Tianbian Pharmaceuticals.
the variety has adsorbent spherical particle type, diameter 0.2-0.4mm of black spherical particles, inside and outside filled with many nano-size (20-15000nM) holes, this product by adsorption of renal failure patients in the gastrointestinal uremia toxin, improve serum muscle linen removal rate, urea nitrogen content, delay the time of chronic renal failure (CFR) patients to start blood dialysis, improve the patient's symptoms.
the difference between this product and ordinary activated carbon in addition to the large amount of toxic adsorption, but also has a small amount of adsorption to digestive enzymes in the gastrointestinal tract, significantly reducing the incidence of constipation.
(1) Granuel (2) rapid-collapse of the variety since the market in 1991 has been steadily climbing sales, maintaining an average annual growth rate of 10%, since 2011 in Japan's domestic sales exceeded 10 billion yen to reach 11.7 billion yen, the variety's sales have been maintained at about 10 billion yen, the annual sales peak is 12.6 billion yen.
is rare for an old breed that has been on the market for more than 20 years.
effective treatment for patients with chronic renal failure is renal dialysis, and the annual medical costs of kidney dialysis are considerable for governments and individuals.
spherical activated carbon can effectively relieve the symptoms of chronic renal failure patients, delay the introduction of dialysis, improve the quality of life of patients, but also reduce the government and individual economic expenses of patients, which is the best of the variety.
the variety is currently in the domestic no active period of declaration of manufacturers, only Shanghai Randa Investment Management Co. , Ltd. in 2007 has declared the variety and made clinical approval, no follow-up progress.
from the perspective of generic drug development, the variety for the adaptation of the large population, has sales bright, and no imitation, non-focus on hot varieties, worth a look.
the other species is a successful case of typical API structure optimization, through new technology to distinguish it from ordinary activated carbon, the value of the increase, clinical value and clinical significance doubled.
artificial cerebrospinal fluid picture from the otsuka pharmaceutical factory's official website Japanese-language products called the レridge hand-washedirrigation fluid, dosage type dose: solution agent, 500mL / bag.
the second part of the
variety consists of two parts, the upper and lower mixing when used: 150mL in volume, glucose and electrolyte solution, pH of about 4.4 (4.0-4.8) second part: volume 350mL, electrolyte solution, pH of about 7.3 (7.0-7.8).
indications: cleaning for craniofacial surgery, cleaning of spinal cord surgery, and endoscopy of neuroendoscopic surgery.
original research company: Otsuka Pharmaceutical Factory.
the variety was listed in Japan in May 2008.
research, the perfusion liquid used in cranial surgery at home and abroad at home and abroad is physiological saline, lactic acid Ringer solution and artificial cerebrospinal fluid (CSF).
the current clinical use of artificial cerebrospinal fluid is configured by the hospital itself, there is no uniform standard, the configuration environment and process is relatively complex, clinical use risk is high and inconvenient.
according to the search and query literature, the clinical brain treatment of artificial cerebrospinal fluid in China includes intracranial infection, ventricular hemorrhage, meningitis, brain trauma intracranial treatment, intracranial tumor removal, cobweb subcavity bleeding and so on.
domestic studies show that artificial cerebrospinal fluid is used in brain surgery irrigation surgery effect and patient prognosis is better than physiological saline, can significantly reduce the physiological saline replacement brought about by the re-damage to brain tissue, but also reduce the incidence of postoperative cerebral edema.
artificial cerebrospinal fluid used 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 needs, its application in brain surgery at home and abroad have been studied and recognized and the doctor's point of view is generally better than the current mainstream application of physiological saline, the form of no finished drug market (except Japan), may be the biggest factor limiting its use.
is generally a drug worthy of further promotion and application.
, from the perspective of new drug development, the species belongs to the existing clinical applications and needs of the species found.
the new drug project 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.
powerful 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 development path of specialty generic drugs and improved new drugs with clinical needs.
flowers in full bloom, each has the direction of the healthy development of the pharmaceutical industry, but also for the current country for pharmaceutical research and development to be clinical-oriented positive response.
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