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CDE drug review weekly report (2016.04.11-2016.04.17)
Time of Update: 2016-04-19
Bpi-7711 capsule: This product was declared by Beida Pharmaceutical Co., Ltd no relevant information has been found at present Xiaobian has studied the company's public pepline, which has the most anti-tumor drugs, but there is no such number!
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Comments on CFDA drug approval in February 2016
Time of Update: 2016-04-13
According to statistics, in February 2016, CFDA approved a total of 38 new domestic approvals Among them, there are 31 chemical approval documents, 7 traditional Chinese medicine approval documents, a
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CDE drug review weekly report (April 4, 2016 to April 10, 2016)
Time of Update: 2016-04-11
Guide: this week, two imported drugs applied for clinical application in China for the first time Watson bio has another class 1 PD-1 monoclonal antibody in the review process The review of Kaine tech
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Catalogue of CDE drug review consultation in March 2016
Time of Update: 2016-04-11
From March 16 to March 18, 2016, the drug review center organized the second drug review consultation meeting in 2016 in Jiangxi Hotel, Beijing A total of 160 experts were invited to attend the meetin
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CFDA approved list of drugs to be marketed in the first quarter of 2016
Time of Update: 2016-04-09
In the first quarter of 2016, CFDA approved 44 drug listing applications, 39 domestic drugs and 5 imported drugs In the classification, there are 37 chemicals in 6 categories, accounting for 84% Accor
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List of approved drugs on the market in March 2016
Time of Update: 2016-04-07
Announcement of the General Administration of the people's Republic of China approving the listing of drugs (No 84, 2016) April 7, 2016 In March 2016, a total of 27 applications for drug listing were
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CDE drug review weekly report (March 28, 2016 to April 3, 2016)
Time of Update: 2016-04-05
Guide: this week, one class 1.1 anti-tumor drug, one class 1 biological product and one class 2 biological product were accepted successfully; in addition, Guangzhou Yuansheng class 1.1 anti-tumor dru
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The 1.1 class of anti Alzheimer's candidate drug GIBH130 has been approved by clinical trial.
Time of Update: 2016-04-01
Comparison of brain hippocampal slices of disease model mice: oral administration of gibh-130 can protect neurons According to the Chinese Academy of Sciences, gibh-130 and its tablets, a new anti Alz
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Class 1.1 new drug PA-824 of Xingtai pharmaceutical, a subsidiary of Fosun Pharmaceutical, was accepted
Time of Update: 2016-03-30
The board of directors and all directors of Shanghai Fosun Pharmaceutical (Group) Co., Ltd guarantee that there are no false records, misleading statements or major omissions in the announcement about
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CDE Drug Evaluation Weekly Report (2016.3.21-2016.3.27)
Time of Update: 2016-03-28
This week, three class 1.1 chemicals entered the review status, three imported drugs applied for clinical application for the first time in China, and three class 1.1 drugs were reviewed In this issue
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[report] the rise of domestic drugs for liver diseases
Time of Update: 2016-03-25
The drugs for liver diseases mainly include the drugs for liver treatment in digestive system and metabolism and the drugs for anti hepatitis virus in systemic anti infection Poor drug accessibility i
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Zhejiang Pharmaceutical launched the first phase I clinical study of arx788
Time of Update: 2016-03-24
Zhejiang medicine / ambrx company announced on March 21 to launch the first phase I clinical study of arx788 (anti HER2 monoclonal antibody ADC) The study will be conducted in multiple centers in Aust
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Approved clinical trial of tpn171, a new class 1.1 anti pulmonary hypertension drug from Shanghai Institute of Medicine
Time of Update: 2016-03-24
It is learned from Shanghai Institute of pharmaceutical research, Chinese Academy of Sciences that tpn171 and its tablets, a new drug for the treatment of pulmonary hypertension (PAH) 1.1, independent
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Zaiding pharmaceutical and bringer Ingelheim reached a CMO cooperation on a new monoclonal antibody
Time of Update: 2016-03-24
Today, Germany's pharmaceutical giant bringer Ingelheim signed a strategic cooperation agreement with zaiding Pharmaceutical Co., Ltd located in Zhangjiang, Shanghai, to provide technology optimizatio
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Jiangsu Yahong Pharmaceutical Technology Co., Ltd. "apl-1202 interim clinical analysis results of phase II in China" made on-site report at Eau 2016 Munich annual meeting
Time of Update: 2016-03-23
(on behalf of Ye Dingwei, vice president of Fudan cancer hospital in Shanghai, Professor Dai Bo made a field report on the results of mid-term analysis of apl-1202 phase II clinical trial in China) On
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Xinlitai new drug R & D investment increased by 118%
Time of Update: 2016-03-23
Xinlitai (002294) released the 2015 financial report on March 22, and realized an annual operating revenue of 3.478 billion yuan, a year-on-year increase of 20.64%; the net profit attributable to the
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The approval document of clinical trial for the new drug of type 1.1 of Sihuan Medicine Diabetes
Time of Update: 2016-03-23
Recently, Sihuan pharmaceutical announced that its main R & D innovative drug for diabetes treatment "jiaglijing" has successfully obtained the clinical approval document from the State Food and drug
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Beihai Kangcheng is authorized by av203
Time of Update: 2016-03-22
On March 21, Beihai Kangcheng obtained the exclusive right to manufacture, develop and market the global (except North America) targeted monoclonal antibody av203 (can017) for the treatment of maligna
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Zhongyuan Xiehe new anticoagulant drug "new vermiculin (EH)" has been approved
Time of Update: 2016-03-22
Recently, exciting news came from the State Food and Drug Administration (CFDA): Beijing sanyiheze Biotechnology Co., Ltd., a subsidiary of Zhongyuan Xiehe, and the Institute of radiation and radiati
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CDE drug review weekly report (March 14, 2016 to March 20, 2016)
Time of Update: 2016-03-21
This week, no new 1.1 kinds of drugs have entered the state of review, and the 1.1 category of the essence medicine has been reviewed by the drug group The Tianjin Institute of pharmacy has approved t
