subject: Simcere Pharmaceutical Endostar Iv Clinical Re-registration To Open The Road To The Domestic Drugs - [print this page] 8 27 Day? 31, of Clinical Oncology, the Eleventh National Conference and Annual Conference 2008, CSCO grand start in Shanghai. During the meeting, the domestic authority of Sun Yan Yuanshi tumor subject to disclose a precursor to a class of pharmaceutical anti-tumor drug Endostar IV clinical study latest developments.
Report preliminary results show that the trial Endostar IV, as expected, progress. As Endostar IV clinical trial is the first received SFDA approval of the IV phase of the project, therefore, re-verify the ex herald of medicine degree in the sample size of the safety and effectiveness, but also for domestic re-marketed medicines Registration of clinical trials experience in exploration and open up a road.
Endostar IV, smoothly Endostar theoretical guidance in the new birth of new targeted biological therapy for cancer drugs, by the State Food and Drug Administration officially approved the first category of biological products, anti-tumor drug, it is the world's first blood vessels Endostatin Cancer Drugs, marked anti-tumor therapy new milestone. In May 2006, the first company in NYSE-listed precursor chemical and biological pharmaceutical drug company will spend 200 million yuan into the arm of ex degrees, and quickly the market. Endostar a listing by the medical profession in particular on cancer drug treatment industry attention.
Although pre-market clinical trials III clinical trials received some evidence, Table Ming Yan combined with chemotherapy can improve the treatment of non-small cell lung objective response and disease control rate, and extend the treatment time and disease progression in patients survival time. Phase III clinical trials, but strict selection criteria, the application of more stringent restrictions on people there, coupled with restrictions on the number of people participate in the pilot, we got the safety and effectiveness of data compared to the extensive post-marketing clinical application of a certain distance.
View of this, November 10, 2006, precursor to cancer medicine invite disciplinary authority of the Sun Yanyuan Shi, Professor Wang Jinwan over, the degree of product ex IV clinical trials.
Endostar IV clinical trials through large sample, multi-center clinical trials, the scope of application in the clinical phase III clinical trial compared a broader basis, for the pre-IPO III clinical trial of safety and effectiveness evaluation.
Far, Endostar IV clinical trials progress. The initial results with Endostar III clinical study of the basic similar samples in a wide range of advanced NSCLC patients, En degree of adverse reactions in the cardiovascular system, lighter, combined with platinum chemotherapy for advanced NSCLC has good synergy did not increase the toxicity of chemotherapy; while Table Arthur H. degrees effectiveness of combination chemotherapy in NSCLC and higher clinical benefit rate, effective than untreated patients retreated patients, better clinical effect on patients with squamous cell carcinoma, but still further clinical observation. Preliminary results show that untreated patients Endostar for gender and pathological type (such as squamous cell carcinoma and adenocarcinoma) is basically no difference. To October 31, 2008, Endostar IV will be completed eventually into the group of work into the group of patients will be expected to reach 2600 cases, in March 2009 will complete the work in all cases of recent follow-up to the end of 2009 to complete most of the cases long-term follow-up work and started to collate all the information and reporting information document prepared in early 2010 to complete the final statistical report and reported to the State Food and Drug Administration.
Endostar IV, opened the first of several domestic The herald Pharmaceutical
Endostar IV clinical trials, causing the domestic and the world medical community's concern, the creation of a domestic pharmaceutical industry, a number of the first: the first nationwide launch of a Class of Anticancer Drug The IV clinical trials; the first approval of a filing with SFDA's National IV of the project; the first mass IV team of full-time inspection of the enterprise; the first to explore the IV specification of re-registration process of the enterprise. Phase IV trial with Endostar smooth progress, degree expected to be the ex July 10, 2007 "Drug Registration" after the enactment of the first domestic success of drug re-registered by drugs and medicines for the domestic market after the re-registration clinical trial experience in exploration and open up a road.
