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CDE Drug Evaluation Weekly Report (2015.7.12-2015.7.18)
Time of Update: 2015-07-20
In the review this week (2015.7.12-2015.7.18), 104 drugs (calculated by acceptance number) entered the review status, 101 chemicals, including 8 drugs in 1.1 category, 34 drugs in 3.1 category and 16
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Taiwan xinpinshengyi Group expects to enter the mainland medical market with the third generation of car-t immunocytotherapy developed by it
Time of Update: 2015-07-18
The third generation of car-t immunocytotherapy of Xinpin biomedical group was launched in the world on July 17, 2015 / BIOON / -- on July 16, 2015, Xinpin biomedical group, a high-tech enterprise of
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Taiwan white biotechnology Tangbao and Gubao are selected into the cross strait drug R & D cooperation project
Time of Update: 2015-07-16
White biotech new drug not only has the successful experience in the research and development of new plant drugs, but also is worth learning from the other side Moreover, "bone treasure" and "sugar tr
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Production approval of adefovir dipivoxil tablets, a new hepatitis B drug of Fangsheng pharmaceutical
Time of Update: 2015-07-16
Recently, the State Food and Drug Administration learned that a new chemical drug of Fangsheng pharmaceutical has obtained the birth permit The drug registration shows that the drug handling status wi
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Haizheng pharmaceutical's third generation insulin recombinant insulin glargine injection has been approved successfully
Time of Update: 2015-07-16
According to the information on CFDA website, the status of the third generation insulin recombinant insulin glargine injection declared by Haizheng Pharmaceutical (600267 SH) for clinical application
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CDE Drug Evaluation Weekly Report (2015.7.5-2015.7.11)
Time of Update: 2015-07-13
In the review this week (2015.7.5-2015.7.11), 123 drugs (calculated by acceptance number) entered the review status, including 115 chemicals, 4 traditional Chinese medicines, 3 biological products for
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CDE Drug Evaluation Report in June 2015
Time of Update: 2015-07-09
In June, the first class 1.1 ddp-4 inhibitor in China was listed 3.1 the first group to rush to imitate and pile up hepatitis C Gilead's sofosbuvir / gs-5816 combination was first declared in China Ha
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Lovastatin ® (bevacizumab) is approved by CFDA for combination chemotherapy of non-small cell lung cancer
Time of Update: 2015-07-08
On July 7, Roche announced that its antineoplastic drug avidin ® (general name: Bevacizumab) has been approved by the State Food and Drug Administration of China and will be used as the first-line tre
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Haizheng pharmaceutical industry joins hands with Sanofi to explore new diabetes treatment
Time of Update: 2015-07-07
Recently, Zhejiang Haizheng Pharmaceutical Co., Ltd announced that the CEO of the company and Sanofi signed a memorandum of non binding Cooperation (hereinafter referred to as the memorandum) to explo
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Inventory of key approved drugs in May 2015
Time of Update: 2015-07-07
For 14 chemicals approved as new drugs, by dosage form, the most common is APIs (7 drugs), followed by injections (3 drugs), tablets (2 drugs), in addition to 1 capsule and 1 granule Among these new d
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From 2015 to now, Lianyungang pharmaceutical company has applied for 88 new drugs and 12 first-class innovative drugs
Time of Update: 2015-07-07
Yesterday, it was learned from Lianyungang pharmaceutical regulatory bureau that since this year, Lianyungang pharmaceutical enterprises have applied for 88 new drugs, 12 of which are first-class inno
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CDE drug review weekly report (June 28, 2015 to July 4, 2015)
Time of Update: 2015-07-06
In the review this week (June 28, 2015 to July 4, 2015), 83 drugs (according to the acceptance number) entered the review status, including 78 chemicals, 3 traditional Chinese medicines and 2 biologic
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Wuzhou Pharmaceutical Co., Ltd., a subsidiary of Zhongheng group, invested 320m in oral insulin pharmaceutical company oramed
Time of Update: 2015-07-04
Zhongheng once again increased its stake in oramed, an Israeli pharmaceutical company invested in before, and obtained the patent right of the other party's oral insulin in China On July 3, Zhongheng
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Phase I clinical trial of rx108, a new antitumor drug of Suzhou Runxin biology, in Australia
Time of Update: 2015-07-03
Recently, Suzhou Runxin Biotechnology Co., Ltd (Runxin Biology), an enterprise in Suzhou biological nano Park, announced that it has started the phase I clinical trial of its self-developed class 1.1
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LVYE pharmaceutical 1.1 new chemical drug anshufaxin hydrochloride sustained release tablets (ly03005) approved for clinical use
Time of Update: 2015-07-03
Recently, LVYE Pharmaceutical Group Co., Ltd has obtained the approval documents of phase II and phase III clinical trials issued by China food and Drug Administration (CFDA) for the new 1.1 chemical
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Kinsey pharmaceutical industry: heavy biological drugs will be listed on the market and import substitution will be realized immediately or rapidly
Time of Update: 2015-07-03
Jinlei, general manager of Changchun jinshai Pharmaceutical Co., Ltd., recently, according to the information on the website of CFDA, the on-site inspection of recombinant human follicle stimulating h
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Analysis report on CDE drug review in June 2015
Time of Update: 2015-07-02
Sph3127, a class 1.1 new drug declared by Shanghai Pharmaceutical Group Co., Ltd., has entered the drug examination center on June 3, 2015, and belongs to the drug variety to be recommended for priori
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CDE drug review weekly report (June 14, 2015 to June 27, 2015)
Time of Update: 2015-06-30
Introduction: 1 Hangzhou Zede Pharmaceutical Technology Co., Ltd applied for cn128 and tablets of class 1 new drug; 2 Jiangsu Wanbang Biochemical Medicine Co., Ltd was the first one in China to apply
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BMS stops developing new antiviral drugs and cancels 100 related positions
Time of Update: 2015-06-29
Bristol Myers Squibb said on June 25 that it would stop developing new antiviral drugs and would remove 100 related positions The company said its early projects on hepatitis B and HIV would also be t
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Kanglaite, an anticancer traditional Chinese medicine injection, has been approved by FDA to enter the third phase of clinical practice
Time of Update: 2015-06-29
Kanglaite has long been a well-known Chinese anti-cancer medicine in China Its injection is a key research topic of the Seventh Five Year Plan of the State Administration of traditional Chinese medicine In 1993, it passed the national appraisal Its functions include: reducing cancer cells, combining with radiotherapy and chemotherapy can reduce the side effects of chemotherapy, improve the body immunity, and significantly improve the quality of life and survival period of patients What is Kanglaite?
