Medical network - June 2 children in the first few days, the CFDA released "adult medication data extrapolation to the pediatric population technical guidelines" formal draft, for the pediatric medicine research and development, especially in pediatric generic drugs research and development is a major positive. Although the number of paediatric drug programs is currently limited, the future of paediatric drug generics will be a new hot topic under the support and promotion of policy.
The author analyzes the paediatric issues since 2016 in order to find the problems in the pediatric programs and the future space.
Pediatrics is the "most"
Since 2016, according to the clinical registration number statistics, registration number, a total of 55 children indications, including left b raschig temple, fumaric acid tenofovir two pyrazole cefuroxime ester, meng LuSi sodium particles, polyethylene glycol recombinant human growth hormone, injection, recombinant human growth hormone pneumococcal conjugate vaccine injection and 13 price is the product registration number in the top five. Therefore, chemical generics and biological products are the main product categories for clinical trials of paediatric drugs.
In terms of indications, the number of clinical registrations for pediatric drugs, especially those involving antiviral infections, is the highest. There are two main classes: one such as fumaric tenofuroful and lamivudine, which are used to prevent hiv-1 infection and the treatment of chronic hepatitis b; Is another type of vaccine, such as the price of 13 pneumococcal conjugate vaccine, as well as the combination of haemophilus influenzae type b, Sabin vaccine inactivated polio strains (Vero cell), the price of 13 pneumococcal polysaccharide conjugate vaccine and enterovirus type 71 inactivated vaccines (human diploid cells).
Epilepsy is the second indication of the clinical registration number of pediatric drugs, the left, the lamotrigine tablet, and the stentyl alcohol-dry suspension.
Respiratory products and clinical hot spots, such as childhood asthma decongestion meng LuSi sodium granule, treatment of lower respiratory tract infection disease, phlegm syndrome of inhaled hydrochloric acid ammonia bromine solution and treatment of children's respiratory tract infection caused by cough phosphoric acid dimethyl silane brown syrup. Paediatric medicine is also often the subject of primary attack, such as the children's lung cough syrup.
From the point of the selection of indications, enterprises prefer indications in the large market potential, the current epidemiological cases increasing in adhd, autism, very few domestic project.
Which generic drugs will be accelerated?
Although the registered indications are children, the minimum age of the clinical trial group is more than 18 years old.
Friends including chongqing medicine pharmaceutical cisco koren pharmaceutical pharmaceutical, sichuan, sichuan sea respectively declare fumaric acid tenofovir two pyrazole cefuroxime ester, jiangsu are thousands pharmaceutical, jiangsu dafeng sea high pharmaceutical, changchun haiyue pharmaceutical respectively declare meng LuSi sodium granule, zhejiang PuLuoKang yulin pharmaceutical, Beijing sihuan pharmaceutical, zhejiang huahai pharmaceutical co., China resources secco pharmaceutical pharmaceutical, rabin degrees are left to declare b raschig, anhui baker biopharmaceutical grace he marina tenofovir, abbott laboratories trading (Shanghai) of pancreatic enzyme enteric capsules 25000, shijiazhuang SiYao department for amyl alcohol dry suspension agent, the zhuhai federal pharmaceutical cefuroxime ester, yichang changjiang pharmaceuticals east sun oseltamivir phosphate grains, zhejiang huahai pharmaceutical of lamotrigine, shijiazhuang longtzer of lamivudine drug and anhui anke biotechnology of recombinant human growth hormone injection. These products are mainly generic drugs.
, according to published in May, 2017 "adult medication data extrapolation to the pediatric population technical guidelines" formally, in the pediatric population data, overseas Chinese adult indications have been approved, if there is no country or region of disease epidemiology, etiology, pathogenesis and prognosis of disease progression, and so no racial difference, no clinical pharmacology, pharmacokinetic and pharmacodynamic and therapeutics (medical practice, safety and efficacy data), and other aspects of difference, pediatric population can continue to use the foreign drug clinical trial data. This means has listed abroad contains children indications of chemical generic drug products, only need persons involved bioequivalence test, can obtain pediatric indications.
In the short term, there is a small number of pediatric indications and the number of listed companies in the country, and the market potential is expected to increase the number of bright reports.
What is the main direction of the project?
For proprietary Chinese medicine, biological products, especially the vaccine, domestic unlisted chemical medicine, still need to start the children's clinical trials, such trials are generally Ⅱ period or more clinical trials.
Vaccines, as shown in table 1, the main start clinical in center for disease control and prevention, the most popular with the manufacturers of the centers for disease control and prevention has a center for disease control and prevention of henan province and jiangsu province center for disease control and prevention.
Table 1 will launch the list of institutions for pediatric clinical trials after 2016
Affiliated to the capital university of medical sciences, Beijing children's hospital is started since 2016 the number of the most clinical institutions, the first hospital of jilin university, children's hospital of jiangxi province and zhejiang university school of medicine, tied for second affiliated children's hospital. The clinical institutions of Chinese medicine are preferred in Chinese hospitals, and the central hospital in hubei province is more popular with manufacturers.
Domestic unlisted chemical medicine now start the project more is the international multicenter clinical trial, such as Pfizer's lyrica 20 mg/mL liquid phase Ⅲ, sanofi the tenet of fluorine amine Ⅲ period clinical, prefer to start in the larger regional influence of tertiary hospital clinical projects.
From the perspective of a clinical institutions to undertake the number, pediatric medicine project is still far from saturation, which means that the restriction is still mainly the cause of pediatric medicine listed in starting the number too little.
In 2016, the citric acid injection of citric acid in yuandong, chengdu, was first reviewed for paediatric drugs because it was approved for clinical purposes. But this is the only product that has been prioritized and listed on the basis of the CDE priority review and incentive policy.
Enterprises for declaration of pediatric medicine still has the phenomenon of cluster: fumaric acid tenofovir two pyrazole cefuroxime ester, meng LuSi sodium, related products, related products are left b raschig companies keen to grab products. Relatively, who planning commission recommended list of pediatric drugs are suffering from the cold (click here to read: the first children's medicine to encourage r&d listing encounter cold: policy support, enterprise why still not input?) It is. The difference between a hot and a cold is visible, and domestic generics firms prefer a more mature product.
After clinical examination and verification, the risk of clinical project is increased, and the enterprises choose the products with high potential for the indication of the indications for profit. From the project in terms of cost, risk control, it is a matter of course, so domestic indications in patients with less but have the demand of clinical medicine gradually became a shortage of medicine case happens quite often.
The products that have been approved for production are still so, not to mention the new ones and the clinical cost of medicine! It is the market's normal response to a drug that has few patients.
