From April 2017 published in the new drug registration related policies and data can be seen, CFDA tilt of new drugs to increase imports of new drugs and major domestic new drugs are CFDA to speed up the review and approval of the focus, and also reflected in the self-examination Verification progress. According to this analysis, imports of new drugs in 2017 will lead to changes in market structure.
| PVA 1799 (PVA BF17) |
The author summarizes the policies and data on the registration of new drugs published in April 2017, explores the intrinsic relationship between the import of the imported drugs, the listing of the first drugs and the priority review, the consistency evaluation and the self-examination and verification, and find the market under the new pattern Trend and project direction.
Two new hepatitis C drugs approved
April 28, CFDA issued a new drug listing announcement, has approved the United States and the United States and China Shibao Po (China) Investment Co., Ltd. of dalazapir hydrochloride tablets and A Shu Ruwei soft capsule market, mainly for adult chronic hepatitis C combination therapy The
Recalling the registration process of two products, darazapril hydrochloride tablets and Ashu Ruiwei soft capsules are priority to review the product. In February 2016, dalazavir hydrochloride tablets and Ashu Ruiwei soft capsule were reported clinically; in November 2016, at the same time, in the fourth batch of clinical self-examination checklist and No. 8 drug clinical trial data on-site verification plan, the month Declaration of production; in December 2016, the production of two products are accepted in the fifth batch of clinical self-examination checklist, but none of the published clinical trials in any of the clinical data test plan.
| PVA 1788 (PVA BP17) |
It is reported that follow-up CFDA will continue to speed up the review of oral direct anti-hepatitis C virus drugs to promote the listing of such drugs.
Priority review into a major new drug
April 27, CDE published “to be included in the priority review process drug registration application of the publicity (the sixteenth batch)” only Zhengda Tianqing Pharmaceutical and Lianyungang Runzhong pharmaceutical declaration of azulodin hydrochloride capsules and APIs The The reason why the drug is included in the proposed priority review process is “significant treatment advantages compared with existing treatment”; There are also reasons for the inclusion of the “major project” for the priority review process
Beads were injected with sodium iloprazole sodium and iloprazole sodium, but eventually failed to enter the “included in the list of priority review varieties”.
| PVA 0588 ( PVA BP05) |
Import a large number of new drugs approved, the market pattern changes
2017 CFDA “on the adjustment of import drug registration matters related to the decision (draft)” comments issued after the announcement of the import of drugs approved to speed up. And from the sixth batch, the import drug acceptance number accounted for the number of self-check acceptance number dropped significantly. Delta data V3.2 found that imports of new drugs in 2017 will lead to changes in market structure.
The first is the hepatitis C drug market, in addition to Bristol-Myers Squibb (China) Investment Co., Ltd. approved two new drugs, there is to declare the listing of the Kyrgyz Yusuo Pupuowei film also entered the sixth batch of self-examination list, the admissibility Is also listed on the CDE “Priority list” and is expected to be available in the second half of 2017. Thus, has been confirmed in Europe and the United States significant efficacy of hepatitis C new drug battle, will be officially staged in China, who is expected to take the lead in China’s health insurance negotiations directory who is more likely to win.
Tyrosine kinase inhibitors, the oseltidomethanesulfonate tablets approved after 2016 were indications of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR T790M mutation positive Treatment, alfanitine maleate indications for the treatment of epidermal growth factor receptor (EGFR) mutations in locally advanced or metastatic NSCLC patients. The active treatment of myelofibrosis and polycythemia vera is the main treatment of irinodipine phosphate. NSCLC drug market competition is expected to intensify in 2017. Diabetes drug market in 2017 there will be a new change. Glucagon-like peptide 1 (GLP-1) receptor agonists, it is expected that risperidone injection is expected to be approved in 2017. Sodium-glucose synergistic transporter 2 (SGLT2), the new batch was approved in 2017, and it is expected that the tablets will be approved soon. (Ⅰ) (II), and the first batch of self-checklist pending the listing of salatrine-metformin sustained-release tablets (Ⅰ) (II) and (III), the sixth batch of self-checklist in the Engler net hydrochloric acid metformin tablets.
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(I) (II) and (III), and telmisartan amlodipine tablets are expected to be available in the second half of 2017.
Self-examination of the sixth batch: oral generic drug began to review?
In the sixth batch of self-examination check list, the only one in the list of priority review of the product is the stone medicine group Ouyi Pharmaceutical Co., Ltd. metformin hydrochloride tablets, selected for the “same production line production, has been listed in the United States, Apply for domestic generic drugs listed. ” I believe that stone powder metformin hydrochloride tablets once approved by means of consistency assessment. In addition to metformin hydrochloride tablets, montelukast chewable tablets, benzoylate soft capsules, tramadol hydrochloride tablets, donepezil hydrochloride tablets and metformin hydrochloride sustained-release tablets are approved in the United States ANDA.
In the fight for the first drug imipramine tablets, lenalidomide capsules, vildagliptin tablets, erlotinine hydrochloride tablets, moxifloxacin hydrochloride tablets, pramipine hydrochloride tablets and paclitaxel for injection (albumin Combination type).
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Among them, lenalidomide capsules, the first batch of self-examination involved in Beijing Shuanglu Pharmaceutical Co., Ltd. products have not yet approved, Zhengda Tianqing Pharmaceutical Group Co., Ltd. products have been in the sixth batch of self-check list Line up. Moxyche hydrochloride tablets, the first batch of self-examination of the company have Chongqing Winbond Pharmaceutical Co., Ltd., Jiangsu Tianyi Pharmaceutical Co., Ltd. and Beijing Wansheng Pharmaceutical Co., Ltd., the fourth batch of self-examination involved in Peking University Pharmaceutical Co., Ltd. , The sixth batch of self-examination involving the Stone Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. and Nanjing Xingang Pharmaceutical Co., Ltd., which has been withdrawn involving Chongqing Winbond Pharmaceutical Co., Ltd. and Jiangsu Tianyi Pharmaceutical Co., Ltd.
to sum up
From April 2017 published in the new drug registration related policies and data can be seen, CFDA tilt of new drugs to increase imports of new drugs and major domestic new drugs are CFDA to speed up the review and approval of the focus, and also reflected in the self-examination Verification progress. Hepatitis C, cancer, diabetes and high blood pressure will be the areas most affected by this policy.
Domestic first imitation competition
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In the second half of 2017 is expected to restart, cardiovascular, cancer and diabetes medication is also the main competition of domestic enterprises.
Consistency evaluation Project competition is also expected to start in the second half of 2017, the same production line in Europe and the United States simultaneously listed products will be expected to obtain priority review, but the record system shorten the registration time, the time between enterprises is not too much time to be approved. It is expected that the consistency of the existing product approval of the reshuffle effect should be the fastest in 2018 began to reflect.
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