Singapore: 3SBio, China based biotechnology company, has signed license agreement with JenKem Technology to develop, manufacture and market PEG-irinotecan, a long-acting polymer-drug conjugate which inhibits topoisomerase I (Topo-I), which is over-expressed in many solid tumors, including colorectal, ovarian, breast, glioma, and small cell and non-small cell lung cancers, in China.

Researchers from JenKem have developed PEG-irinotecan to treat Topo-I over-expressed cancers. The first generation Topo-I inhibitor approved by the Food and Drug Administration in the United States (US FDA) in 1994 showed a high initial peak concentration and short half-life, associated with high toxicity and reduced efficacy respectively, which greatly limits its clinical applications.In contrast, the body's natural enzymatic processes gradually degrade the linkers within JenKem's larger PEG-irinotecan molecule, enabling a slow, continuous release of the active drug to passively and selectively target the leaky vasculature of tumor tissues and reducing tumor cell division by inhibiting Topo-I.

It is currently expected that the Investigational New Drug (IND) application will be filed with the China Food and Drug Administration (CFDA) by the end of 2014.

3SBio intends to initially develop PEG-irinotecan for metastatic colorectal cancer and breast cancer, as well as platinum-resistant ovarian cancer. In China, the incidence rates for colorectal cancer, breast cancer and ovarian cancer are 29.44 per 100,000, 42.02 per 100,000 and 5.1 per 100,000 annually.

"We are pleased to collaborate with JenKem and look forward to moving PEG-irinotecan into clinical trials," Dr Jing Lou, CEO of 3SBio commented. "This agreement is a natural fit with our mission to develop therapies for patients with late stage or metastatic cancers. 3SBio continues to seek opportunities to develop novel drug candidates for refractory cancers and other unmet medical needs, particularly in 3SBio's core therapeutic areas of oncology, nephrology and hematology."

"PEG-irinotecan is a novel drug candidate with great potential to treat many types of solid tumors," Dr Xuan Zhao, CEO of JenKem commented. "3SBio is an established industry leader in the innovative biological field in China, which makes them an ideal partner for long-term collaboration. Together, we can maximize this opportunity and benefit tens of thousands of Chinese patients suffering from metastatic breast cancer and colorectal cancer, platinum-resistant ovarian cancer and other severe diseases."