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 treatment 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-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon 3SBio management's current expectations, and actual results could differ materially. Among the factors that could cause 3SBio's actual results to differ from what the company currently anticipates may include competition from other domestic and foreign pharmaceutical companies; the expected market growth for pharmaceutical products in China; market acceptance of 3SBio products; expected hospital or patient demand for our products; the completion of 3SBio's ongoing clinical trials as planned; receipt and timing of regulatory approvals for 3SBio's new products and uses; 3SBio's ability to expand its production, sales and distribution network and other aspects of its operations; its ability to effectively protect its intellectual property; changes in the healthcare industry in China, including changes in the healthcare policies and regulations of the PRC government and changes in the healthcare insurance sector in the PRC; and fluctuations in general economic and business conditions in China. For additional information on these and other factors that may affect the 3SBio's financial results, please refer to the company's filings with the Securities and Exchange Commission at http://www.sec.gov . 3SBio undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.
For more information, please contact:
Investor Contact:
David Chen, COO
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
