3SBio Inc. (3SBio), a leading biotechnology company, has received an Investigational New Drug (IND) approval letter from the China Food and Drug Administration (CFDA) for PEG-irinotecan, a long-acting polymer-drug conjugate which inhibits topoisomerase I (Topo-I).
Topo-I is over expressed in many solid tumours, including colorectal, ovarian, breast, glioma, and small cell and non-small cell lung cancers. Each year, approximately 1.2 million patients are diagnosed with one of these types of cancer in China.
PEG-irinotecan was originally developed by JenKem Technology Co., Ltd (JenKem), a Chinese biotechnology company, to treat Topo-I over-expressed cancers. In September 2014, 3SBio entered into an exclusive license agreement with JenKem for the development, manufacturing and marketing in Mainland China of PEG-irinotecan. Irinotecan, the first generation Topo-I inhibitor, was approved by the United States Food and Drug Administration (US FDA) in 1994. It shows a high initial peak concentration and short half-life, associated with high toxicity and reduced efficacy, which greatly limits its clinical applications. In contrast, the body's natural enzymatic processes gradually degrade the linkers within the larger PEG-irinotecan molecule, enabling a slow, continuous release of the active drug to passively and selectively target the leaky vasculature of tumour tissues and reducing tumour cell division by inhibiting Topo-I.
3SBio intends to develop PEG-irinotecan as a National Class I drug for relapsed or refractory cancers, such as colorectal cancer, metastatic breast cancer, and platinum-resistant ovarian cancer. In China, the incidence rates for colorectal cancer, breast cancer and ovarian cancer are 33.1 per 100,000, 27.3 per 100,000 and 4.9 per 100,000 annually.
"We are pleased to receive the IND approval from the CFDA and look forward to moving PEG-irinotecan into clinical trials in China," Dr. Jing Lou, Chairman and CEO of 3SBio commented. "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 rheumatology."
"PEG-irinotecan is a novel drug candidate with great potential to treat many types of solid tumours," 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."
JenKem is an emerging biotechnology company in China. JenKem focuses on the development and manufacturing of high quality polyethylene glycol (PEG) products and derivatives, and related custom synthesis and PEGylation services.
Irinotecan is a topoisomerase I inhibitor indicated for first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum; and patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. The major side effects of irinotecan include early and late forms of diarrhoea, and severe myelosuppression. Irinotecan was introduced into the world market between 1994 and 1996.
PEG-irinotecan is a novel long-acting topoisomerase I inhibitor to treat Topo-I over-expressed cancers. The first generation Topo-I inhibitors show a high initial peak concentration (associated with high toxicity) and short half-life (associated with reduced efficacy). In contrast, the large PEG-irinotecan molecule is inactive when administered. PEG-irinotecan passively targets tumour tissues selectively due to their leaky vasculature and high permeability of large molecules. Over time, the body's natural enzymatic processes slowly degrade the linkers within the molecule and continuously release active drug to stop tumour cell division through inhibition of Topo-I. Therefore, the long acting drug candidate might suppress tumour growth throughout the entire chemotherapy cycle sustainably, while significantly reducing cytotoxicity by decreasing the peak exposure.
3SBio is a leading biotechnology company in the People's Republic of China (the PRC) founded in 1993. As a pioneer in the PRC biotechnology industry, 3SBio has extensive expertise in developing, manufacturing and marketing biopharmaceuticals.