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| The ability of self-medication for self-medication enterprises: which products are voluntarily withdrawn and re-declared? |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-15 11:39:31 Number Browse：791 |
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The medical network on August 14 clinical self-examination has entered the third year. By clinical comprehensive verification is parallel with chemical medicine registration for examination and approval reform policy, can be seen from the policy announced by the clinical inspection, many companies go on the road: shiyao consistency evaluation of domestic and overseas yanda, zhengda domestic first copy and new drugs, the weather is fine hengrui yanda overseas and domestic imitation and new drugs. These layouts didn't start in 2017, and the forward-looking layout won the company.
On August 2, the CFDA released on drug clinical trial data check list for inspection registration of announcement no. 91 (2017), namely the eighth batch inspection list, this is the third time in 2017 released by the inspection check list. In the eighth batch, 61 have completed clinical trials to declare production or import drug registration applications, 44 of which are acceptance Numbers declared in 2017.
Import self-check PK
The declaration of Chinese new drugs is declining
In the eighth batch of self-inspection lists, the import registration accounted for 32.8%, which was lower than the seventh batch of self-inspection, but still higher than the total of 19.4% of the total of the eight approved lists. In the eighth batch of the list, the top three provinces in China are hebei, guangdong and jiangsu provinces. The top three provinces in the overall eight batches of self-inspection are jiangsu, Beijing and shandong.
According to the declaration category, 45.9% of the 8th batch of self-inspection list comes from the registered application of the existing national standard, 19.7% is the supplementary application, and 18.0% is the import registration. Eight batch inspection list in 2094 to accept order, new drug applications are still accounted for the highest, accounted for 48%, mainly is from the first batch of inspection list, after the second inspection of new drugs in the batch list of no more than 20%.
This may and the reform of chemical medicine classification method has certain relevance: after 2016 new declare the original unlisted generic drugs are no longer belongs to a new drug, and belong to the generic chemical medicine new classification of the third class; Under the consistency evaluation and chemical medicine classification reform, registration filing requirements has been gradually clear in the second half of 2016, enterprises want to under the new rules, to declare all in wait-and-see policy measures.
Self-inspection of enterprise rankings
The strong dare to save value projects
2017 in clinical check list to accept the most number of enterprises is the meaning shiyao group pharmaceutical co., LTD., declare products are moxifloxacin hydrochloride, metformin hydrochloride, injecting paclitaxel (albumin combined type), clopidogrel bisulfate tablet, for sand for tablet and metformin hydrochloride zyban for Greg and los.
In the second place, the company is zhengda tianqing, the products of which are reported to be the amine capsules, the anrotiene hydrochloride capsules, the injection of benzamustine hydrochloride, the gifetini tablet and the injection of azazoside.
From clinical comprehensive verification can be found that the most fold not rao manufacturers than a board that the weather is fine and fumaric acid to declare tenofovir two pyrazole cefuroxime ester into the first clinical inspection check list, and take the initiative to withdraw; Entering the third batch of clinical self-inspection verification list, and voluntarily withdraw; Now we are in the fifth batch of clinical self-check list. And competition manufacturer chengdu times pharmaceutical co., LTD., qilu pharmaceutical co., LTD. And anhui baker biopharmaceutical pharmaceutical co., LTD. Have received production approval.
Zhengda sunny pharmaceutical injection of hydrochloric acid benzene da mo SiTing into the first clinical inspection check list and take the initiative to withdraw, announced on August 3, 2017 of the eighth visible zhengda group of clinical inspection check list again declare the weather is fine.
The injection of benzamustine hydrochloride is the anti-tumor drug approved by the FDA in 2008 and is the product that most manufacturers are willing to salvage at present. Indications for the drug for the treatment of chronic lymphocytic leukemia (CLL), the rituxan (rituximab, mabthera) or with rituxan solutions in the process of the treatment, or treatment of 6 months still progression of inert B cell non-hodgkin's lymphoma (NHL) patients. The products of Cephalon, the original manufacturer, have not been listed and are now in the seventh batch of clinical self-check verification list.
Why is it that the injection is the product that the most manufacturers are willing to save? Because two manufacturers have withdrawn and saved. Precede the nanjing east yuan in addition to the board that the weather is fine pharmaceutical co., LTD., the injection of hydrochloric acid benzene da mo SiTing clinical inspection check list, also in the first batch of first sound east yuan also took the initiative to withdraw, than the board early one step to declare, the weather is fine now and in the seventh batch of clinical inspection check list.
In addition to trying to save the injection of bendamostine hydrochloride, nanjing ancestors also wanted to rescue the praksoro hydrochloride tablets that treat idiopathic Parkinson's disease. Pramipexole hydrochloride domestic only the original German boehringer ingelheim, generic drugs are currently Zhejiang Jingxin Pharmaceutical Co., ltd. and nanjing first sound east yuan Pharmaceutical Co., Ltd in clinical inspection check list, Zhejiang Jingxin Pharmaceutical Co., ltd. in the sixth group of clinical inspection check list, first sound after the first clinical inspection check list to withdraw to declare, in the seventh batch of clinical inspection check list.
Check your product rankings
Imported drugs go hand in hand with generic drugs
Table 2 product acceptance number from high to low 10 products in each year
As shown in table 2, 2017 check list check acceptance number ranking the first product is bayer medical human recombinant coagulation factor for injection, a total of six, are from the clinical application of 2016 number, all in the seventh batch of self checking list (announcement no. 42, 2017).
In the second place, there were moxifloxacin hydrochloride tablets and ngli hydrochloride tablets.
Moxifloxacin hydrochloride is a generic manufacturers declaration, nanjing xingang pharmaceutical co., LTD., nolato, respectively the Italian pharmaceutical co., LTD. Nanjing SAN pharmaceutical co., LTD., sichuan for the pharmaceutical co., LTD. And chongqing winbond pharmaceutical co., LTD., which chongqing winbond pharmaceutical co., LTD. Is the first comprehensive withdrawn again declare.
Boehringer ingohan (China) investment co., LTD., ngli net hydrochloric acid metformin, has five acceptance Numbers, both of which are clinical applications for 2016, and both are from the seventh batch of self-inspection lists.
In the fourth place, there are platyclas hydrochloride tablets and hydrobromic acid sulfuroxetine tablets. In 2016, the list of priority review and approval was added in March 2017, and the seventh batch of self-check list was entered in May.
Tied for sixth for lamivudine tablets, left the b raschig temple, the drug lenalidomide capsule, for sand for sodium, sand kubah valsartan pills, injection of hydrochloric acid benzene da mo SiTing, metformin hydrochloride, pulling, hydrochloric acid, luo luo si dispersible tablet for capsule.
The lamivudine tablets of shijiazhuang longze pharmaceutical co., LTD. Were withdrawn in the first batch of self-examination and are now in the eighth batch of self-inspection.
Zhengda sunny drug lenalidomide capsule for the first time into the inspection list, the first comprehensive list of Beijing SL Pharmaceutical Co., ltd. is still in the review stage, double heron came into priority review in October 2016, still no conclusion.
Dachatinib tablets Beijing double egrets have not entered the clinical self-examination list since the first batch of self-investigation has been withdrawn. Shiyao group oyi pharmaceutical co., ltd. entered the eighth batch of self-inspection list for the second domestic manufacturer's opportunity to list.
The United States has listed, and in April 2017, it has entered the sixth batch of self-inspection list, which was approved in June.
The first list of the three accepted names of valsartan sodium tablets in norwarsaw kuba qu was entered into the list of priority reviews in March 2017 and the seventh batch of self-inspection lists in May. The three acceptance Numbers have been given priority review lists in December 2016, and the product was approved in July for the third batch of self-inspection lists.
A new type of new drug, anrotiani capsules, was first reviewed in April 2017 and entered the seventh batch of self-examination in May. In addition, hutchison whampoa pharmaceuticals 1 class of new drug furquinii capsules has been declared for production, and has entered the eighth batch of self-inspection list in 2017.
It is a supplementary application for the import supplement of the dispersible tablets of lalastan tablets and novartis.
To sum up, the first listed imported new drugs and domestic generic oral medicine are two categories of the top ten products of the first ten products in 2017. This is different from the 2015 self-inspection list, which is based on homemade generics. New drugs are imported from the possibility of approved, is expected to be approved in 2017, domestic generics with shiyao group the meaning pharmaceutical co., LTD. Of metformin hydrochloride is most likely in 2017 years.
Looking forward to > > >
In 2016, the treatment of HIV - 1 virus infection and AIDS at the forefront of biological pharmaceutical (nanjing) co., LTD. Class 1 new drug for injection YiBoWei ty in August 2016 to enter the third batch of self checking list (announcement no. 142, 2016), into the priority review in November, is the first clinical check list after implementation class 1 chemical medicine new drug application products.
In 2017, two new drugs are listed in the self-inspection list, and both are tyrosine kinase products. In 2015, beida actinib entered the health care negotiations, and in 2017, he entered the health care negotiation catalogue, setting a precedent for the entry of medical insurance for such domestic new drugs.
The new drug that has been approved in the self-examination list is currently only a new drug for biological products, and the new drug has been approved.
Judging from the current enterprise layout, individual enterprises have completed the step of the replacement planning of cash flow products mainly based on generics, attacking the new drug high profit. The differentiation of enterprise competitiveness is becoming more and more obvious.
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