Navigation Links
3SBio Inc. Applies for SFDA Registrational Trial for Feraheme(TM)
Date:1/8/2010

SHENYANG, China, Jan. 8 /PRNewswire-Asia-FirstCall/ -- 3SBio Inc. (Nasdaq: SSRX), a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a registrational clinical trial to the Chinese State Food and Drug Administration ("SFDA") for Feraheme (ferumoxytol) Injection for intravenous use. Feraheme is an intravenous iron therapy that 3SBio licensed from AMAG Pharmaceuticals, Inc. (Nasdaq: AMAG) for development in China for the treatment of iron deficiency anemia in adult patients with chronic kidney disease ("CKD").

Feraheme was approved on June 30, 2009 by the U.S. Food and Drug Administration for the same indication for which 3SBio is seeking approval in China and launched commercially in the U.S. by AMAG in July 2009. As previously announced, 3SBio has exclusive rights to develop and commercialize Feraheme in China. Once approved by the SFDA, 3SBio will commence a multi-center randomized efficacy and safety study in China with approximately 200 CKD patients, measuring the mean change in hemoglobin from baseline at Day 35 after first dose.

Dr. Jing Lou, Chief Executive Officer of 3SBio comments: "We are pleased with the timely submission of the Feraheme clinical trial application to the SFDA in China, representing a major milestone and our commitment to bringing this innovative therapy to Chinese CKD patients in need. We look forward to working with the SFDA to ensure an efficient review process."

Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals comments: "3SBio is the ideal partner to bring Fer
'/>"/>

SOURCE 3SBio Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. 3SBio Inc. Announces Unaudited Third Quarter 2009 Results
2. 3SBio Inc. to Report 2009 Third Quarter Earnings on November 12, 2009
3. 3SBio Inc. to Hold 2009 Annual General Meeting on October 12, 2009
4. 3SBio Inc. Announces Appointment of Ernst & Young Hua Ming as Independent Auditor
5. 3SBio Inc. Announces Unaudited Fourth Quarter and Fiscal Year 2008 Results
6. 3SBio Inc. Receives Official Recognition as a High-Tech Enterprise
7. 3SBio Inc. to Report 2008 Fourth Quarter and Full Year Earnings on March 11, 2009
8. 3SBio Inc. Appoints Mr. Bo Tan as Chief Financial Officer
9. 3SBio Inc. to Present at the Piper Jaffray 20th Annual Health Care Conference
10. 3SBio Inc. Announces Third Quarter 2008 Results
11. 3SBio Inc. Files for SFDA Approval of NuLeusin
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... 15, 2014  Bill Jacobs Automotive, a group of car dealerships ... with the Heartland Blood Center and offering free oil change ... takes place Saturday, Jan. 18 at the Bill Jacobs Cadillac ... (Photo: http://photos.prnewswire.com/prnh/20140115/MN46637 )  The Bill ...
(Date:1/15/2014)... SAN JOSE, California , January 15, 2014 ... for cancer, today announced the appointment of Thomas C Reynolds ... over 20 years, development experience gained in the biotechnology industry, ... "I am delighted to welcome Tom at this transformative ...
(Date:1/15/2014)... Two champions of science, technology, engineering, ... an annual competition for middle and high school students ... STEM study. The competition presents students with real-world problems ... Aptitude, Mathematics, and Sciences is a program administered ...
(Date:1/15/2014)... AudioNotch is the internet's leading provider of ... of tinnitus. Patients listen to sound therapy that is ... of weeks to months, their tinnitus volume decreases. , AudioNotch ... Music and Notched White Noise. Now, AudioNotch is pleased to ...
Breaking Biology Technology:Join the Bill Jacobs Auto blood drive and receive a free oil change 2Oxford BioTherapeutics Appoints Thomas C Reynolds MD, PhD to its Board of Directors 2Oxford BioTherapeutics Appoints Thomas C Reynolds MD, PhD to its Board of Directors 3Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 2Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 3Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 4Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 5
... Commercial Expansion in, Fast-Growing European Market; Add Complementary Products, Technologies and ... ... Standalone Molecular, Diagnostics Company, Providing Broad Range of Innovative Products to Meet ... Diverse Customer Needs Around the World -, SAN DIEGO, June 3 ...
... /PRNewswire-FirstCall/ - Spectral Diagnostics Inc.,(TSX: SDI) today ... of,its EAA(TM) Endotoxin Activity Assay in combination ... at the Practical Aspects of,Extracorporeal Blood Purification ... in Moscow, Russia from May 28th-30th., ...
... Resources,(ARR), a leading Chicago-based agency that brings together ... a program designed,to remove some of the pressure ... Extended Choice, the program offers intended parents, for ... during a 72-hour period.,This means that participants have ...
Cached Biology Technology:Gen-Probe Launches Cash Tender Offer to Acquire Belgian Molecular Diagnostics Company Innogenetics 2Gen-Probe Launches Cash Tender Offer to Acquire Belgian Molecular Diagnostics Company Innogenetics 3Gen-Probe Launches Cash Tender Offer to Acquire Belgian Molecular Diagnostics Company Innogenetics 4Gen-Probe Launches Cash Tender Offer to Acquire Belgian Molecular Diagnostics Company Innogenetics 5Gen-Probe Launches Cash Tender Offer to Acquire Belgian Molecular Diagnostics Company Innogenetics 6Gen-Probe Launches Cash Tender Offer to Acquire Belgian Molecular Diagnostics Company Innogenetics 7Spectral announces presentation of data on improving sepsis patient management with EAA(TM) and Toraymyxin(TM) combination 2Spectral announces presentation of data on improving sepsis patient management with EAA(TM) and Toraymyxin(TM) combination 3ARR Offers Parents 'Extended Choice' in Egg Donor Selections 2
(Date:4/17/2014)... fish consumption advisories for expecting mothers are ineffective ... persistent organic pollutants (POPs). , The study, ... of Toronto Scarborough PhD student Matt Binnington and ... of environmental contamination, a mother,s compliance with advisories, ... influenced exposure in her children. , Their model ...
(Date:4/17/2014)... one per eight hundred births, Down syndrome - or ... of intellectual disability. It results from a chromosomal abnormality ... of chromosome 21 (1% of the human genome). A ... the Department of Genetic Medicine and Development at the ... Nature , shed light on how the extra ...
(Date:4/17/2014)... bone marrow need to produce hydrogen sulfide in order ... a new study from the Center for Craniofacial Molecular ... USC. , Professor Songtao Shi, principal investigator on the ... the cells governs the flow of calcium ions. The ... results in osteogenesis, or the creation of new bone ...
Breaking Biology News(10 mins):Fish consumption advisories fail to cover all types of contaminants 2Trisomy 21: How an extra little chromosome throws the entire genome off balance 2Trisomy 21: How an extra little chromosome throws the entire genome off balance 3
... professors at The University of Texas Health Science Center ... Kevin Morano, Ph.D. have been elected fellows into ... the world,s largest general scientific society and publisher of ... for his leadership to advance public health and his ...
... WASHINGTON In a case series seemingly tailor-made for cinematic ... a batch of potato-based "wine" (also known as pruno) cooked ... online Tuesday in Annals of Emergency Medicine (" ... Prison Botulism Outbreak ") . "Evidently the incorporation of ...
... (CO2) in the atmosphere is used by plants to build their ... in which they grow. If the way of cultivating the earth ... to the atmosphere in the form of CO2, it will be ... causes of global warming and climate change. The Soil Management Group ...
Cached Biology News:UTHealth faculty members elected to prestigious scientific association 2Jailhouse wine is not as delicious as it sounds, could be deadly 2Project on sustainable management and gas emission reduction in irrigation farming 2Project on sustainable management and gas emission reduction in irrigation farming 3
Request Info...
Request Info...
Request Info...
Epi-Grids™ Colony Grid Templates are easy-to-use griding templates that allow rapid organization of colonies from initial screening plates and for preparing precise master plates....
Biology Products: