3SBio to Develop DJ5 for Progressive Renal Failure in ADPKD Patients

SHENYANG, China, Oct. 29, 2013 /PRNewswire/ -- 3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced the acquisition of patents for DJ5, a novel non-TZD PPARgamma agonist with potential to retard progressive renal failure in patients with autosomal dominant polycystic kidney disease ("ADPKD'). 3SBio intends to seek approval from the CFDA to undertake phase one clinical trials in China.

ADPKD is the most frequent hereditary renal disease which affects about 1 in 400 to 1 in 1,000 people. The estimated patient population is approximately 1.5 million in China and 10 million globally. Approximately 50% of people with ADPKD will develop end stage kidney disease and require dialysis or kidney transplantation.

Researchers with the Shanghai Institute of Materia Medica, Chinese Academy of Science discovered and synthesized DJ5 and investigated its effect on disease progression and possible side effects in the Han:SPRD rat model of polycystic kidney disease. They concluded that DJ5 markedly delays the loss of renal function, inhibits the cyst epithelial cell proliferation, and retards cyst development in Han:SPRD rats with ADPKD, without causing cardiac side effects.

Previous studies have shown that PPARgamma agonist Thioglitazones (TZDs) could reduce renal cystogenesis, retard the progression of kidney failure and prolong survival in ADPKD animal models. However, TZDs treatment was associated with fluid retention and heart failure.

Dr. Jing Lou, CEO of 3SBio commented, "We are pleased to be associated with SIMM and look forward to moving DJ5 into clinical trials in China. 3SBio continues to seek opportunities to support novel approaches to kidney related disorders and other unmet medical needs, particularly in 3SBio's core therapeutic areas of nephrology and oncology."

About Shanghai Institute of Materia, Chinese Academy of Sciences

Shanghai Institute of Materia Medica (SIMM) has developed more than 70 drugs, including 10 listed in the Chinese Pharmacopoeia. Key research areas include tumors, cardiovascular, neurological, metabolic, autoimmune and infectious diseases. SIMM is staffed by over 400 researchers and is supported by the MoST, CAS and Shanghai Municipality. Chinese Academy of Sciences (CAS) is a leading academic institution and comprehensive research and development center in natural science, technological science and high-tech innovation in China

About 3SBio Inc.

3SBio is a fully integrated, profitable biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China. Since its founding in 1993, 3SBio's R&D efforts have resulted in four NDAs for biological medicines, including TPIAO, the first rhTPO approved worldwide. Pipeline candidates include Uricase PEG-20, a modified pegylated recombinant uricase from Candida utilis for the treatment of refractory gout and tumor lysis syndrome which has completed US Phase 1 trials; NuPIAO, a long-lasting rhEPO for anemia associated with renal failure or chemotherapy and peri-operative blood cell mobilization which has received SFDA approval to initiate clinical trials; and SSS07, an anti-TNF monoclonal antibody for treating rheumatoid arthritis, psoriasis, and potentially other inflammatory diseases. A new state-of-the-art mammalian biological manufacturing facility in Shenyang is the first and only rhEPO facility in China that conforms to both Chinese and European pharmacopeia standards. Planning is underway to develop monoclonal antibody manufacturing capabilities. 3SBio is China's leading specialist in nephrology and oncology supportive care with 580 sales professionals covering over 3,000 hospitals in key cities supported by a nationwide network of 120 distributors and logistics providers. EPIAO has been the top selling rhEPO product in China since 2002 with a market share over 40%. Please see www.3sbio.com for additional information.

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