3SBio Acquires Global Rights to Anti-TNF mAb Acquisition expands international product pipeline Phase 1 trial for rheumatoid arthritis in progress in China
SHENYANG, China, June 22, 2015 /PRNewswire/ -- 3SBio Inc., (HKEX: 1530) (“3SBio”), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that it has acquired the ex-China global rights to Apexigen's anti-TNF monoclonal antibody (“mAb”) technology. 3SBio previously acquired the China rights from Apexigen in 2006.
3SBio’s anti-TNF mAb, designated SSS07, has completed pre-clinical testing and demonstrated higher potency than the best-known available TNF inhibitors, including adalimumab and infliximab, potentially improving treatment options for patients with rheumatoid arthritis and other inflammatory diseases.
In March 2015, 3SBio initiated a dose-escalating Phase I trial for SSS07 in China (NCT02460393). A Phase 1b trial is also scheduled to start in early 2016 using multiple doses in healthy individuals.
“Dosing of the first cohort of Phase I trial participants with SSS07 was a significant milestone towards our goal of introducing a safe, effective and affordable treatment for the estimated 17 million patients globally who suffer from rheumatoid arthritis, including 4.5 to 5.0 million in China”, commented Dr. Jing Lou, 3SBio's Chairman and CEO, “Acquiring the global rights to this anti-TNF mAb technology also positions 3SBio to participate in the US$35 billion global market for anti-TNF inhibitors.”
About Anti-TNF mAb/SSS07
Anti-TNF mAb/SSS07 is a genetically engineered monoclonal antibody that inhibits TNF. TNF is one of the key chemokine messengers that regulate the inflammatory process and plays an important role in the underlying mechanisms of conditions such as rheumatoid arthritis, psoriasis, and many other inflammatory disorders. When human body produces too much TNF, it overwhelms the immune system’s ability to control inflammation of the joints or of psoriasis-affected skin areas. The TNF inhibitors are molecules that disrupt the TNF function. Such blockage has been shown to result in a significant reduction in inflammatory activity and reduce symptoms, inhibit the progression of structural damage, and improve physical function in patients with moderate to severe rheumatoid arthritis. Several TNF inhibitors developed by other companies have been approved by the US FDA and the Chinese FDA. SSS07's pre-clinical testing showed higher potency than the best-known available products, including adalimumab and infliximab, potentially improving treatment options for rheumatoid arthritis patients.
The prevalence of rheumatoid arthritis in China is approximately 0.32% to 0.36%, or 4.5 million to 5.0 million patients. The number of rheumatoid arthritis patients in China is expected to increase with an aging population and increasing urbanization, presenting favorable market potential. According to IMS, the TNF inhibitor market in China reached RMB708 million in 2013. The Global Burden of Disease 2010 study estimated that the global prevalence of rheumatoid arthritis was 0.24%.
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 SSS07, an anti-TNF monoclonal antibody with a Phase I trial underway in China for the treatment of rheumatoid arthritis; NuPIAO/SSS06, a long-acting erythropoiesis- stimulating agent (ESA) for anemia associated with renal failure or chemotherapy and peri-operative blood cell mobilization which has entered into Phase I clinical trials in China; Uricase PEG- 20/SSS11, a modified pegylated recombinant uricase from Candida utilis for the treatment of refractory gout and tumor lysis syndrome which has completed US Phase I trials; Leukotuximab/SSS19, an anti-CD43/JL-1 monoclonal antibody for treating acute leukemia; and Tanibirumab/SSS23, an anti-VEGFR2 monoclonal antibody for treating solid tumors.
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.
3SBio is China’s leading specialist in nephrology and oncology supportive care with more than 700 sales and marketing professionals covering over 3,400 hospitals in key cities supported by a nationwide network of over 110 distributors and logistics providers. EPIAO has been the top selling rhEPO product in China since 2002 with a market share over 40%.
3SBio trades on the Stock Exchange of Hong Kong under code 1530. Please visit www.3sbio.com for additional information.
About Apexigen Inc.
Apexigen, based in San Carlos, California, is a clinical-stage biopharmaceutical company focusing on the discovery and development of innovative antibody-based therapeutics for the treatment of cancer and other life-threatening or debilitating diseases. Apexigen is advancing its lead immuno- oncology antibody (APX005M) in the clinical development. Using its robust technology platform, Apexigen has developed a pipeline of therapeutic candidates for cancer and inflammatory diseases and established seven corporate partnerships including strategic partnerships with multi-national pharmaceutical companies, including Janssen Biotech, Alcon Laboratories and Toray Industries to discover and develop first-in-class antibody therapeutics.