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 Feraheme to iron deficiency anemia patients with chronic kidney disease in China. This step represents an important milestone in our efforts to broaden the global reach of Feraheme."

Important Safety Information about Feraheme

Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.

In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects receiving Feraheme, including three patients with serious hypotensive reactions. Serious hypersensitivity reactions were reported in 0.2% (3/1726) of patients. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and the drug should only be administered when treatment of hypersensitivity reactions is readily available. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging but will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.

In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients were diarrhea, nausea, dizziness, hypotension, constipation and peripheral edema.

About 3SBio Inc.

3SBio Inc. is a leading, fully integrated biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, primarily in China. For more information, please visit 3SBio on the web at http://www.3sbio.com .

Safe Harbor Statement

This press release contains statements of a forward-looking nature. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. You can identify these forward-looking statements by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. The accuracy of these statements may be impacted by a number of business factors and uncertainties that could cause actual results to differ materially from those projected or anticipated, including factors related to: the ability of 3SBio to initiate and successfully complete the registrational trial for Feraheme; the risk that 3SBio may not be able to commercially offer Feraheme in China in a timely manner or at all for whatever reason, including possible failure to obtain SFDA approval; uncertainty as to hospital or patient demand for 3SBio's products; uncertainties regarding 3SBio's ability to successfully compete in the intravenous iron replacement market in China; uncertainties regarding 3SBio's ability to obtain favorable insurance coverage and pricing for Feraheme, if approved by the SFDA; changes in the healthcare industry in China, including changes in the healthcare policies and regulations of the P.R.C. government and changes in the healthcare insurance sector in the P.R.C.; fluctuations in general economic and business conditions in China; and other risks outlined in 3SBio's filings with the Securities and Exchange Commission. 3SBio does not undertake any obligation to update this forward-looking information, except as required under applicable law.

    Feraheme(TM) is a trademark of AMAG Pharmaceuticals, Inc.

    For more information, please contact:

    Investor Contacts
     Bo Tan
     Chief Financial Officer
     3SBio Inc.
     Tel:   +86-24-2581-1820
     Email: ir@3SBio.com

     Tom Folinsbee
     Director of Investor Relations
     3SBio Inc.
     Tel:   +852-8191-6991
     Email: ir@3SBio.com

SOURCE 3SBio Inc.

RELATED LINKS
http://www.3sbio.com

'/>"/>

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

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:6/23/2016)... Prostate Cancer Foundation (PCF) is pleased to announce 24 new Young ... cancer. Members of the Class of 2016 were selected from a pool of ... More About the Class of 2016 PCF Young Investigators ... ... ...
(Date:6/23/2016)... , June 23, 2016   EpiBiome , a ... $1 million in debt financing from Silicon Valley Bank ... automation and to advance its drug development efforts, as ... facility. "SVB has been an incredible strategic ... services a traditional bank would provide," said Dr. ...
(Date:6/23/2016)... , ... June 23, 2016 , ... STACS DNA Inc., ... Leader at the Arkansas State Crime Laboratory, has joined STACS DNA as a Field ... DNA team,” said Jocelyn Tremblay, President and COO of STACS DNA. “In further expanding ...
(Date:6/23/2016)... , June 23, 2016 Apellis Pharmaceuticals, ... 1 clinical trials of its complement C3 inhibitor, ... and multiple ascending dose studies designed to assess ... of subcutaneous injection in healthy adult volunteers. ... either as a single dose (ranging from 45 ...
Breaking Biology Technology:
(Date:6/20/2016)... 20, 2016 Securus Technologies, a leading ... for public safety, investigation, corrections and monitoring announced ... it has secured the final acceptance by all ... Managed Access Systems (MAS) installed. Furthermore, Securus will ... be installed by October, 2016. MAS distinguishes between ...
(Date:6/9/2016)... June 9, 2016 Paris ... Teleste,s video security solution to ensure the safety of people ... during the major tournament Teleste, an international ... and services, announced today that its video security solution will ... to back up public safety across the country. The system ...
(Date:6/2/2016)... 2016   The Weather Company , an IBM Business ... industry-first capability in which consumers will be able to interact ... questions via voice or text and receive relevant information about ... Marketers have long sought an advertising solution that can ... personal, relevant and valuable; and can scale across millions of ...
Breaking Biology News(10 mins):