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CDE drug review weekly report (July 18, 2016 to July 24, 2016)
Time of Update: 2016-07-18
1 This week (2016.7.10-7.17) there are still more than 20 drugs in the review status The new chemical registration classification has been put into use, and the class 1 Chemical is still at the forefr
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GSK announces that Cerex®, a vaccine to prevent cervical cancer in women, has been approved for marketing in China
Time of Update: 2016-07-18
GlaxoSmithKline Cervarix - human papillomavirus (HPV) infection is the main cause of cervical cancer HPV vaccination will provide protection for the majority of Chinese women at risk of HPV infection
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[June] CFDA approved 5 drug listing applications
Time of Update: 2016-07-13
In June 2016, CFDA approved 5 drug listing applications, all of which were domestic chemicals In June 2016, it was approved to be listed in the drug catalog, product name, specification, dosage form a
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Chenxin Pharmaceutical Co., Ltd. upgraded 18aa-i to market
Time of Update: 2016-07-12
In May this year, the new plastic ampoule packaging of Longbo ® children's compound amino acid injection 18aa-1, one of Chenxin's top products, was approved for market After the upgrade of packaging,
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CDE drug review weekly report (July 11, 2016 to July 17, 2016)
Time of Update: 2016-07-11
The number of drugs entering the evaluation center continued to decrease this week, with no drugs in 1.1 and 3.1 In addition, the review of lanthanum polystyrene sulfonate and its powder, a new class
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Fosun obtained the approval of clinical trial of enzalutamide soft capsule
Time of Update: 2016-07-06
On July 5, two listed pharmaceutical companies announced that they had obtained clinical approval documents and two announced that they had obtained patent invention certificates Jichuan Pharmaceutica
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CDE drug review weekly report (July 4, 2016 to July 10, 2016)
Time of Update: 2016-07-04
The listing application of liprazole sodium for injection of Lizhu group has entered the CDE evaluation center, and the clinical application of paclitaxel (PDG coupling type) and Zhengda Tianqing tq-b
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Fangyuan pharmaceutical invests another 200 million R & D new drugs, two first-class new drugs for patent application
Time of Update: 2016-07-02
The HPLC-PAD method of etimicin sulfate developed by Changzhou Fangyuan Pharmaceutical Co., Ltd and relevant units was not only included in Chinese Pharmacopoeia 2015, but also imitated by European an
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Haizheng 1.1 new drug "Haize Mabu" is approved to add new specifications and change production process
Time of Update: 2016-06-29
Haizheng Pharmaceutical Co., Ltd issued a notice on June 28, announcing that it has received the notice of approval opinions on the varieties of raw materials of isapirone and Haize mAb approved and i
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[follow up analysis] six withdrawal items of clinical self-examination were restarted by be test. How about the progress of consistency evaluation?
Time of Update: 2016-06-28
Affected by the withdrawal of nearly 70% of the acceptance number of the clinical self-examination, the approval of the production approval is also bleak According to the data of the new approval publ
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CDE drug review weekly report (2016.06.27-2016.07.03)
Time of Update: 2016-06-27
This week, Otsuka applied for brexpiprazole tablet in China for the first time What is the change from approval to review of Kanghong Compaq CEPP production application? The clinical application of go
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Fosun drug hlx07 is approved for clinical trial in Taiwan
Time of Update: 2016-06-21
Fosun Pharmaceutical (02196 HK) (600196 SH) announced that its holding subsidiary Hanlin biotechnology received a letter from Taiwan's "Ministry of health and welfare" on Approving the clinical trial
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Analysis report on drug registration of Jiangsu Province in 2015
Time of Update: 2016-06-21
[Abstract] Jiangsu Province has a strong momentum in drug research and development, and the number of drug registration applications has been ranked first in China for years This paper focuses on the
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After Pfizer, the first clinical approval of "azithromycin sustained release dry suspension" was obtained by domestic pharmaceutical companies
Time of Update: 2016-06-21
The indications of azithromycin sustained-release dry suspension in Jianmin Pharmaceutical Co., Ltd are acute bacterial sinusitis in adults caused by sensitive bacterial infection, pneumonia in childr
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Taigexyn, a new antibiotic product approved by CFDA, is the first class 1.1 new drug developed by Taiwan enterprises and approved for sale in mainland China
Time of Update: 2016-06-20
June 20, 2016 --The State Food and Drug Administration (CFDA) recently approved taigexyn (nemonoxacin) capsule, a new antibiotic product developed by Taiwan's Taigen biotechnology company, to be sold
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CDE drug review weekly report (2016.06.20-2016.06.26)
Time of Update: 2016-06-20
Roche's cobimetinib tablet and bispecific antibody emisizumab injection have applied for clinical application for the first time in China The evaluation of Haizheng 1.1 new drug dtrmhs-07 capsule and
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Zhongsheng pharmaceutical industry cooperates with Wuxi apptec to develop 7 first-class new drug projects
Time of Update: 2016-06-17
Guangdong Zhongsheng Pharmaceutical Co., Ltd (Zhongsheng pharmaceutical) signed a strategic cooperation agreement with Wuxi apptec on July 13, 2015 The cooperation period between the two parties is 5
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A large number of new drug applications received by CDE
Time of Update: 2016-06-16
Solanezumab injection solanezumab, an anti amyloid monoclonal antibody, is also one of the most promising pipeline drugs in Eli Lilly If it can be successfully listed, it is expected to bring nearly $
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Two new indications of Tianshili new drug "puyouke" have been approved
Time of Update: 2016-06-16
On June 15, Tianshili announced that its subsidiary, Shanghai Tianshili, has obtained two copies of approval documents for clinical trials of drugs approved and issued by CFDA, and approved two new in
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CDE drug review weekly report (2016.06.12-2016.06.19)
Time of Update: 2016-06-13
Abstract: this week, two tinines made the headlines, one is that the yifeitini tablet of Yangtze River entered CDE, and the other is that the review of four ring celotinib tablet was completed In addi
