Navigation Links
3SBio Inc. Files for SFDA Approval of High-dose (36,000 IU) EPIAO

SHENYANG, China, Sept. 25 /Xinhua-PRNewswire-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 filed with the Chinese State Food and Drug Administration (SFDA) for approval of a 36,000 IU dosage formulation of EPIAO for the treatment of anemia associated with chemotherapy in cancer patients. If approved, high-dose EPIAO would be the only dosage form of this kind available in China.

High dose EPIAO is designed for the rapid restoration of hemoglobin to normal levels among cancer patients. The 36,000 IU dosage is comparable to the standardized dose used globally for the chemotherapy-induced anemia, allowing for less frequent administration than lower dosage forms, which in turn is expected to provide greater convenience for both patients and caregivers.

The clinical trial examined the safety and efficacy of a weekly subcutaneous injection of 36,000 IU EPIAO in oncology patients compared with a regimen of three times per week administration of 10,000 IU EPIAO. The results showed that 70% of the patients receiving high-dose EPIAO injections had Hemoglobin improvement of 1-2 g/dL from baseline, similar to those receiving three times per week dosing of 10,000 IU EPIAO. More importantly, the weekly administration of 36,000 IU EPIAO demonstrated equivalent safety and tolerability profiles as the three times per week 10,000 IU EPIAO.

Commenting on the news, Dr. Jing Lou, CEO of 3SBio, said, "I am pleased to announce that we have reached another important milestone for one of our key pipeline products. The submission for approval of high-dose EPIAO is based on positive data which demonstrates that an once a week injection of 36,000 IU high-dose EPIAO is as effective as the three times per week 10,000 IU low-dose EPIAO in treating cancer patients with chemotherapy-induced anemia. If approved, high-dose EPIAO will provide patients and physicians in China with a new, safe and more convenient treatment of anemia resulting from chemotherapy. Furthermore, we believe that the greater convenience provided by high-dose EPIAO treatment versus existing treatment options will be a key factor in helping to fuel the growth of the highly under-penetrated oncology market in China."

About the Phase III Data

The Phase III study was a multi-center, randomized, active-controlled trial that enrolled 206 non-myeloid malignant tumor patients. The testing group, including 104 patients, was given 36,000 IU EPIAO subcutaneously once a week for eight weeks. The control group, including 102 patients, was given 10,000 IU EPIAO three times a week for eight weeks. The primary endpoint of the study was the improvement of the Hemoglobin level for > 1-2 g/dL compared to the baseline level. The trial result shows that 70% of patients on high- dose EPIAO injections had Hemoglobin improvement of at least 1-2 g/dL from baseline level, similar to those receiving three times per week dosing of 10,000 IU EPIAO. In addition, the patients were assessed with the peak Hemoglobin value, the nadir of Hemoglobin value, the time it took for the Hemoglobin level to increase for more than 1g/dL and 2g/dL, and the need for blood transfusion for each group. There was no significant difference between the two groups in these secondary endpoints.

In addition, the safety of high-dose EPIAO was comparable to the 10,000 IU EPIAO. The most common adverse effect related to high-dose EPIAO was low fever. The patients recovered within a short period of time.

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: .

For more information, please contact:

Investor Contact:

Kevin Teo, CFO

3SBio Inc.

Tel: +86-24-2581-1820

Investor Relations (US):

Mahmoud Siddig

Taylor Rafferty

Tel: +1-212-889-4350

Investor Relations (HK):

Ruby Yim

Taylor Rafferty

Tel: +852-3196-3712

Media Contact:

Jason Marshall

Taylor Rafferty

Tel: +1-212-889-4350

Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. 3SBio Inc. to Present at the UBS Global Life Sciences Conference
2. 3SBio Inc. to Hold Annual General Meeting
3. 3SBio Inc. Schedules 2007 Third Quarter Earnings Release On Tuesday, November 13, 2007
4. 3SBio Inc. To Present at the 19th Annual Piper Jaffray Health Care Conference
5. 3SBio Inc. Announces Appointment of Kevin Sow Peng Teo as Chief Financial Officer
6. 3SBio Inc. to Present at the Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device Conference
7. 3SBio Inc. Schedules 2007 Fourth Quarter and Full Year Earnings Release on Wednesday, February 20, 2008
8. 3SBio Inc. Announces Change to the Board of Directors
9. 3SBio Inc. Announces Unaudited Fourth Quarter and Fiscal Year 2007 Results
10. 3SBio Inc. Announces Promotion of David Chen as Chief Operating Officer
11. 3SBio Inc. Approves Share Repurchase Program
Post Your Comments:
(Date:11/30/2015)... ... November 30, 2015 , ... Global Stem Cells Group announced the opening ... the cities of Arica and Iquique in northern Chile. The facilities are part of GSCG’s ... most advanced protocols and techniques in stem cell medicine to patients from around the world. ...
(Date:11/30/2015)... , Nov. 30, 2015 Harvard ... ), a biotechnology company developing bioengineered organ implants ... written notification from The NASDAQ Stock Market that ... price requirements. The letter noted that as a ... common stock having exceeded $1.00 per share for ...
(Date:11/30/2015)... DIEGO , Nov. 30, 2015 Human ... that the company has acquired Cypher Genomics, Inc., a ... robust human genomic interpretation software solutions. The ... will join HLI including Cypher CEO and Co-founder, Ashley ... of HLI,s Pediatric Business.  Financial details of the deal ...
(Date:11/30/2015)... and MAGDEBURG, Germany , November ... NeuroRehabilitation (ECNR) in Vienna, Austria ... European Congress of NeuroRehabilitation (ECNR) in Vienna, ... --> NovaVision, a wholly owned subsidiary of Vycor Medical, ... version of its Internet-delivered NovaVision Therapy Suite at the ...
Breaking Biology Technology:
(Date:11/12/2015)...  Arxspan has entered into an agreement with ... use of its ArxLab cloud-based suite of biological ... will support the institute,s efforts to electronically manage ... internally and with external collaborators. The ArxLab suite ... Institute,s electronic laboratory notebook, compound and assay registration, ...
(Date:11/10/2015)... 2015  In this report, the biomarkers ... product, type, application, disease indication, and geography. ... are consumables, services, software. The type segments ... efficacy biomarkers, and validation biomarkers. The applications ... development, drug discovery and development, personalized medicine, ...
(Date:11/9/2015)... Calif. , Nov. 9, 2015  Synaptics Inc. ... interface solutions, today announced broader entry into the automotive ... solutions that match the pace of consumer electronics human ... biometric sensors are ideal for the automotive industry and ... Europe , ...
Breaking Biology News(10 mins):