February 21, according to relevant data provided to the "daily economic news" reporter, 2015, national food drug safety administration of drug approval center received 32428 for drug registration, and down to the data in 2016 to 20034, down 38.22% year on year.
In addition, new drug research and development outsourcing service domestic enterprises (hereinafter referred to as the CRO) Po dhi medicine (300404, SZ) recently released preliminary results also show that in 2016 net profit attributable to shareholders of listed companies is 70% ~ 70% lower than a year ago.
On February 22, bo dhi medical securities transactions on behalf of an interview with reporters said, at present most of the research is done in internal audits and requirements to the check list, pause to undertake new projects, and suspend has to undertake in the research of project cases in group work, the company also put great energy according to the new inspection standard, revise and improve the clinical inspection process in the progress of the research project inevitably affected by severe."
Drug companies are tightening new drugs to declare
In July 2015, the state food and drug supervision and administration bureau announced that 1622 has been declared production or import pending for drug registration, to carry out the drug clinical trial data verification audits.
A series of comprehensive verification for a lot of drug companies withdraw the application for registration. According to incomplete statistics, only 2015 years, the companies will have to withdraw the application for drug registration hundreds, withdraw and not through varieties of more than eighty percent, which the enterprise actively withdrawn species accounted for 77%.
By 2016, collective "tightening" to declare the number of drug companies.
Salty reach, according to data provided 2015 national food drug safety administration of drug approval center received 32428 drug registration application, including new drugs and generic drugs are 2985 and 1905 respectively.
But in 2016, the review center received 20034 for drug registration, shrank by 38.22%, compared to the number of accepted new drugs and generic drugs is also reduced to 818 and 647.
R&d and production of a well-known guangdong drug firms who told the "daily economic news" reporter, on the one hand, the chemical medicine classification of new registered a formal announcement and supporting documents have been issued in 2016, the drug registration regulations of unclear, has caused many companies to maintain wait-and-see status. Clinical trials, on the other hand, less resources, prices rise, also let drug firms more cautious.
According to introducing, at present domestic varieties of a single drug the consistency of the evaluation of the market price is 3 million ~ 6 million yuan, after the cost of between 50 ~ 600000 yuan.
CRO industry in a pain in the short term
Clinical trial is a prerequisite for new drug approval, is the longest and most expensive drugs listed process link.
CRO as mediation of drug companies and the clinical test units, also in the checking experience pain in the storm.
Bo pharmaceutical industry according to preliminary results released, is expected in 2016 net profit attributable to shareholders of listed companies of 00000 ~ 7.69 million yuan, fell 70% ~ 70%.
Bo medical securities transactions on behalf of explains, 2016 affected by the drug clinical trial data verification audits last, companies in clinical trials research project progress is slow, makes clinical research services revenue fell sharply.
Another tiger pharmaceutical CRO enterprise also predicts that the clinical test check list and verification activities due to the influence of such factors as slowing the project schedule, cost, last year's net profit attributable to shareholders of listed companies increased range is between 20% ~ 5%.
In the case of rising costs, economic medicine to the daily economic news "reporter said that in the short term, to promote the quality of clinical trials and the increase of r&d, will improve the bidders cautious of new drug r&d, the state drug clinical trial asks is ceaseless rise is likely to increase the difficulty of the clinical trials. But in the long run, the CRO industry directly benefit from the consistency evaluation work, market demand is expected to surge.
"More and more normative quality standards can make CRO companies increased investment in hardware and software, increase operating costs, small companies may face an elimination, have a certain size and in strict accordance with the operation regulation of laws and regulations of the company will win more market share." The source stressed that since 2016, most of the drug companies are busy project check list for verification of finishing touches, busy consistency evaluation of existing varieties, inevitably delay the development of new products work, but this situation will improve soon.
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