Navigation Links
3SBio Obtains SFDA Approval to Join Global Phase III Trial for Voclosporin
Date:6/28/2012

SHENYANG, China, June 28, 2012 /PRNewswire-Asia-FirstCall/ -- 3SBio Inc. (NASDAQ: SSRX) ("3SBio" or "the Company"), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that the State Food and Drug Administration ("SFDA") has approved 3SBio's application to conduct the China arm of the multi-center phase III trial of voclosporin, a new generation calcineurin inhibitor licensed from Isotechnika Pharma Inc. ("Isotechnika") (TSX: ISA).

According to the approved protocol, this will be a phase III, randomized, multi-center, concentration-controlled comparison study on renal transplant patients. Patient enrollment is expected to begin in the third quarter of 2012.  

Further details about voclosporin and 3SBio's strategic partnership with Isotechnika are available in the press releases dated August 24, 2010, September 14, 2010, November 19, 2010 and May 12, 2011 which are archived in the investor relations section of www.3SBio.com.

About 3SBio Inc.

3SBio is a leading, fully integrated, profitable biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China.  Its focus is on addressing large markets with significant unmet medical needs in nephrology, oncology, supportive cancer care, inflammation and infectious diseases.  With headquarters and GMP-certified manufacturing facilities in Shenyang, PRC, 3SBio employs over 800 people. Shares trade in the form of American Depositary Shares (ADSs) on the NASDAQ stock market under the ticker symbol "SSRX". Please see www.3SBio.com for more information.

Safe Harbor Statement

This press release and the comments issued by 3SBio related to SFDA approval of the Company joining global Phase III trial for voclosporin may contain 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 expressions. The accuracy of these statements may be impacted by a number of risks factors and uncertainties, including factors related to:  the success and timely completion of phase III trial, and our and our partner's ability to successfully obtain regulatory approvals and commercialize voclosporin on a timely basis; and other risks related to new product development as outlined in 3SBio's filings with the Securities and Exchange Commission. 3SBio does not undertake any obligation to update such forward-looking information, except as required under applicable law.

Investor Contacts

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

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


'/>"/>
SOURCE 3SBio Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. 3SBio Inc. To Present at the DB Access Asia Conference 2012
2. 3SBio Inc. Schedules Unaudited First Quarter 2012 Results
3. Biodel Obtains Exclusive License to Aegis Therapeutics Technologies for Development and Commercialization of Glucagon Pharmaceutical Formulations
4. Cardiac Rhythm Management Devices Market to 2017 - Technological Innovations, Regulatory Approvals and Increasing Disease Prevalence Present Growth Opportunities
5. Obesity Care Continuum (OCC) Applauds FDA for Approval of New Obesity Drug
6. Obesity journal publishes new study on lorcaserin, a weight-loss medication recommended for approval by FDA advisory panel
7. Daiichi Sankyo, Inc. Receives FDA Approval to Package Product at New Facility in Bethlehem, PA
8. China Biologic Receives SFDA Manufacturing Approval Certificate for Human Coagulation Factor VIII
9. ERT Announces Stockholder Approval of Merger
10. CMC Biologics Achieves Successful Pre-Approval European GMP Inspection by MHRA for Commercial Manufacturing
11. GSK Receives FDA Approval for MenHibrix®
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... Jan. 20, 2017  Ethicon Endo-Surgery, Inc. ... Medical Products, Inc., a privately held medical ... electrosurgical tools used in operating rooms worldwide. ... Ethicon,s* advanced energy devices with Megadyne,s innovative ... step forward in Ethicon,s goal to deliver ...
(Date:1/20/2017)... Entscheidung fällt als ... Die internationale humanitäre Stadt soll um knapp 2800 m² ... Seine Hoheit Scheich Muhammad bin Raschid ... von Dubai , hat den Auftrag ... Humanitarian City IHC) zu verdreifachen, um den Betrieb zur ...
(Date:1/19/2017)... 2017 The Global Therapy Partnering Terms and ... partnering deals and agreements entered into by the world,s ... - Top deals by value - Deals listed by ... The report provides understanding and access to the ... leading healthcare companies. The report provides an analysis ...
Breaking Medicine Technology:
(Date:1/20/2017)... Raton, FL (PRWEB) , ... January 20, 2017 , ... ... level of nutritional and bodybuilding supplements, announced it attended the January ECRM trade show ... respected bodybuilder and nutritional scientist who was determined to create a line of products ...
(Date:1/20/2017)... ... January 20, 2017 , ... "TransFlare 4K Mystique comes with 44 colorful mysterious ... X," said Christina Austin - CEO of Pixel Film Studios. , TransFlare 4K ... 4K Mystique lens flare and light leak transitions have a very high-dynamic range for ...
(Date:1/20/2017)... ... January 20, 2017 , ... “Mary Magdalene: Grace is Greater than Sin”: ... who witnessed Jesus Christ firsthand. “Mary Magdalene: Grace is Greater than Sin” is the ... an educator interacting with countless women who had little knowledge of the female characters ...
(Date:1/20/2017)... ... ... Chocolate Biscuit”: a biographical account following a man who went on to support his country ... Ivey, born in Lynn Haven, Florida and at the age of 5, his family moved ... he joined the Navy and got married right out of boot camp. , He ...
(Date:1/20/2017)... ... 2017 , ... D R Burton Healthcare Products LLC, makers ... in a study indicating superior performance against competitive products in secretion clearance. ... Positive Expiratory Pressure Devices During Simulated Breathing“ was published in the winter issue ...
Breaking Medicine News(10 mins):