SHENYANG, China, Nov. 10 /Xinhua-PRNewswire/ -- 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 NuLeusin for the treatment of late stage metastatic renal cell carcinoma. If approved, NuLeusin is expected to be the only treatment of this kind available in China.
NuLeusin, 3SBio's second-generation IL-2, is a genetically modified form of IL-2 possessing improved biochemical properties over naturally occurring IL-2. Clinical trials examined the safety and efficacy of two treatment cycles of subcutaneous injections of NuLeusin. During each six-week treatment cycle, patients were given daily doses of 7MIU/square meter in the induction phase and daily doses of 3.5MIU/square meter in the maintenance phase. The results showed an overall efficacy (Complete Response +Partial Response) of 12.73% and a disease control rate (Complete Response+ Partial Response+ Stable Disease) of 60%. Compared to Chiron's Proleukin, a treatment available in the United States, which is believed to be the only similar product on the market today, Nuleusin demonstrated similar levels of efficacy with a much lower dosage. More importantly, NuLeusin showed an improved safety and tolerability profile in patients who participated in the Phase III study.
"Today's submission comes only a little over one month following our
submission for high dosage EPIAO and once again demonstrates our
outstanding research and development capabilities and our strong ability to
execute on our business plan," stated Dr. Jing Lou, Chief Executive Officer
of 3SBio. "NuLeusin was developed to provide a new immunotherapy regimen
for oncologists to treat patients with late stage metastatic renal cell
carcinoma. Upon approval, we believe many patients who have exhausted their
|SOURCE 3SBio Inc.|
Copyright©2008 PR Newswire.
All rights reserved