3SBio's PEG-irinotecan Wins IND Approval From China FDA

SHENYANG, ChinaMarch 7, 2016 /PRNewswire/ -- 3SBio Inc., ("3SBio") a leading biotechnology company based in China focusing on researching, developing, manufacturing and marketing biopharmaceutical products, announced today that it 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 tumors, 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 China1.

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 tumor tissues and reducing tumor 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 annually1.

"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 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."

About JenKem

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. JenKem caters to the PEGylation needs of the pharmaceutical, biotechnology, medical device and diagnostics, and emerging chemical specialty markets, from laboratory scale through commercial scale.

About Irinotecan

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 diarrhea, and severe myelosuppression. Irinotecan was introduced into the world market between 1994 and 1996.

About PEG-irinotecan

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 tumor 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 tumor cell division through inhibition of Topo-I. Therefore, the long acting drug candidate might suppress tumor growth throughout the entire chemotherapy cycle sustainably, while significantly reducing cytotoxicity by decreasing the peak exposure.

About 3SBio

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. Three core products, TPIAO, Yisaipu and EPIAO are market leaders in the PRC. TPIAO is the only commercialized recombinant human thrombopoietin (rhTPO) product in the world. Yisaipu, a recombinant human tumor necrosis factor-α receptor II (TNFR) – IgG Fc fusion protein developed by Shanghai CP Guojian Pharmaceutical Co., Ltd. ("Guojian"), one of 3SBio's subsidiaries, for the treatment of rheumatoid arthritis is the industry leader with a market share in excess of 60% according to IMS data. EPIAO, a recombinant human erythropoietin (rhEPO) product, together with the other rhEPO product acquired recently, SEPO, is the dominant market leader in the rhEPOmarket, with a market share more than the combined market shares of the next five largest competitors, according to IMS data. In addition, 3SBio has more than 50 other products in the nephrology, oncology, rheumatology, dermatology and other therapeutic areas. 3SBio is focused on building an innovative product pipeline, with over 20 National Class 1 candidates under development.

3SBio maintains manufacturing facilities in Shenyang, Benxi, ShanghaiHangzhou and Shenzhen, as well as in Como, Italy, with a total of over 3,000 employees. A 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. In July 2015, 3SBio acquired Zhejiang Wansheng Pharmaceutical Co., Ltd, which specializes in R&D, production and sales of chemically synthesized pharmaceuticals. In November 2015, 3SBio acquired a controlling interest in Guojian, a leading company in China's antibody sector that develops and commercializes new biologic therapies targeting cancer, autoimmune diseases and organ transplantation immunosuppression treatment. Guojian's antibody manufacturing capacity is among the largest in the industry.

3SBio's pharmaceutical products are marketed and sold in 32 provinces, autonomous regions and special municipalities in the PRC, as well as a number of foreign countries and regions. 3SBio's nationwide sales and distribution network covers over 3,400 hospitals and medical institutions in the PRC. 3SBio is also actively pursuing international expansion through acquisition, licensing and partnerships.

Please visit www.3sbio.com for additional information.

1. Report of Cancer Incidence and Mortality in China, 2012, China Cancer, 2016, 25(1): 1-8

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Donald Wyatt

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