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3SBio Inc. Files for SFDA Approval of NuLeusin
Date:11/10/2008

tment options will benefit from this new alternative. In addition, Nuleusin is expected to further expand 3SBio's existing presence in the rapidly growing oncology market in China."

About the Phase III Study

The Phase III study was a multi-center, open label, single arm study carried out in nine first-tier hospitals in Beijing. The study enrolled 75 patients with post surgery renal cell carcinoma metastasis into two six-week treatment cycles, with a two-week break between each cycle. Patients were given subcutaneous injections of 3.5MIU/ square meter NuLeusin every twelve hours, twice a day, for five consecutive days in the first week of each treatment cycle during the induction phase. From the second week onward, during the maintenance phase, patients received daily subcutaneous injections of 3.5MIU/square meter NuLeusin for five consecutive days each week. The maximum number of treatment cycles patients could receive was three. The clinical endpoint was assessed using computerized tomography scan image of tumor response.

The results of Phase III study demonstrated NuLeusin to be an effective treatment for metastatic renal cell carcinoma with improved safety and tolerability, with an overall efficacy of 12.73% and a disease control rate of 60% (per protocol site). The possible causes for the difference in efficacy compared to Proleukin could be variations in patient race, injection dosage, and route of administration and treatment time. The most common adverse effect related to NuLeusin was low fever and injection site reactions.

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

Statements in this release may contain "forward-look
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SOURCE 3SBio Inc.
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