SHENYANG, China, Nov. 10 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 DrugAdministration (SFDA) for approval of NuLeusin for the treatment of late stagemetastatic renal cell carcinoma. If approved, NuLeusin is expected to be theonly treatment of this kind available in China.
NuLeusin, 3SBio's second-generation IL-2, is a genetically modified formof IL-2 possessing improved biochemical properties over naturally occurringIL-2. Clinical trials examined the safety and efficacy of two treatmentcycles of subcutaneous injections of NuLeusin. During each six-week treatmentcycle, patients were given daily doses of 7MIU/square meter in the inductionphase and daily doses of 3.5MIU/square meter in the maintenance phase. Theresults showed an overall efficacy (Complete Response +Partial Response) of12.73% and a disease control rate (Complete Response+ Partial Response+ StableDisease) of 60%. Compared to Chiron's Proleukin, a treatment available in theUnited States, which is believed to be the only similar product on the markettoday, Nuleusin demonstrated similar levels of efficacy with a much lowerdosage. More importantly, NuLeusin showed an improved safety and tolerabilityprofile in patients who participated in the Phase III study.
"Today's submission comes only a little over one month following oursubmission for high dosage EPIAO and once again demonstrates our outstandingresearch and development capabilities and our strong ability to execute on ourbusiness plan," stated Dr. Jing Lou, Chief Executive Officer of 3SBio."NuLeusin was developed to provide a new immunotherapy regimen for oncologiststo treat patients with late stage metastatic renal cell carcinoma. Uponapproval, we believe many patients who have exhausted their treatment optionswill benefit from this new alternative. In addition, Nuleusin is expected tofurther expand 3SBio's existing presence in the rapidly growing oncologymarket in China."
About the Phase III Study
The Phase III study was a multi-center, open label, single arm studycarried out in nine first-tier hospitals in Beijing. The study enrolled 75patients with post surgery renal cell carcinoma metastasis into two six-weektreatment cycles, with a two-week break between each cycle. Patients weregiven subcutaneous injections of 3.5MIU/ square meter NuLeusin every twelvehours, twice a day, for five consecutive days in the first week of eachtreatment cycle during the induction phase. From the second week onward,during the maintenance phase, patients received daily subcutaneous injectionsof 3.5MIU/square meter NuLeusin for five consecutive days each week. Themaximum number of treatment cycles patients could receive was three. Theclinical endpoint was assessed using computerized tomography scan image oftumor response.
The results of Phase III study demonstrated NuLeusin to be an effectivetreatment for metastatic renal cell carcinoma with improved safety andtolerability, with an overall efficacy of 12.73% and a disease control rate of60% (per protocol site). The possible causes for the difference in efficacycompared to Proleukin could be variations in patient race, injection dosage,and route of administration and treatment time. The most common adverseeffect related to NuLeusin was low fever and injection site reactions.
About 3SBio Inc.
3SBio Inc. is a leading, fully integrated biotechnology company focused onresearching, developing, manufacturing and marketing biopharmaceuticalproducts, primarily in China. For more information, please visit 3SBio on theweb at: http://www.3sbio.com.
Safe Harbor Statement
Statements in this release may contain "forward-looking" statements withinthe meaning of Section 27A of the Securities Act of 1933, as amended, andSection 21E of the Securities Exchange Act of 1934, as amended, and as definedin the Private Securities Litigation Reform Act of 1995. These statements arebased upon 3SBio management's current expectations, and actual results coulddiffer materially. Among the factors that could cause 3SBio's actual resultsto differ from what the company currently anticipates may include competitionfrom other domestic and foreign pharmaceutical companies; the expected marketgrowth for pharmaceutical products in China; market acceptance of 3SBioproducts; expected hospital or patient demand for our products; the completionof 3SBio's ongoing clinical trials as planned; receipt and timing ofregulatory approvals for 3SBio's new products and uses; 3SBio's ability toexpand its production, sales and distribution network and other aspects of itsoperations; its ability to effectively protect its intellectual property;changes in the healthcare industry in China, including changes in thehealthcare policies and regulations of the PRC government and changes in thehealthcare insurance sector in the PRC; and fluctuations in general economicand business conditions in China. For additional information on these andother factors that may affect the 3SBio's financial results, please refer tothe company's filings with the Securities and Exchange Commission athttp://www.sec.gov . 3SBio undertakes no obligation to update or revise theseforward-looking statements, whether as a result of new information, futureevents 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
SOURCE 3SBio Inc.