News and Research on 3SBio, Inc. (SSRX)
Business Description
3SBio, Inc., a biotechnology company, focuses on researching, developing, manufacturing and marketing biopharmaceutical products in China. The company's recombinant, or genetically engineered, protein-based products and product candidates are designed to address markets with unmet medical needs in nephrology, oncology, supportive cancer care, inflammation and infectious diseases. Major products offered by the company include EPIAO and TPIAO; and its legacy products are Intefen and Inleusin.
Products
EPIAO: EPIAO is an injectable recombinant human erythropoietin, or EPO, that is used to stimulate the production of red blood cells in patients with anemia and to reduce the need for blood transfusions. EPIAO is a protein-based therapeutic comparable in structure and function to Amgen, Inc.’s Epogen and Kirin Brewery Company Limited’s ESPO.
EPIAO is approved by the SFDA for three distinct indications: anemia associated with chronic renal failure; red blood cell mobilization, which is the process in which red blood cells are stimulated to proliferate, before, during, and after surgery; and anemia associated with chemotherapy in cancer patients with non-myeloid malignancies, which are cancers that do not originate in the bone marrow or involve myeloid cells, or non-lymphocyte white blood cells found in the bone marrow. In addition, the company is in late-stage clinical trials for a concentrated high dose (36,000 IU/vial) formulation of EPIAO, which is designed to allow for less frequent administration, benefiting both patients and doctors.
TPIAO: The company launched TPIAO, an internally developed protein-based therapeutic product, in January 2006. This product is a recombinant human thrombopoietin, or TPO, indicated for the treatment of chemotherapy-induced thrombocytopenia, a deficiency of platelets. TPIAO represents the first protein-based therapeutic of its type approved for thrombocytopenia in China.
Intefen: Intefen is the company's recombinant interferon alpha-2a product. Intefen is indicated for the treatment of carcinomas of the lymphatic or hematopoietic system, such as lymphoma and leukemia, and viral infectious diseases, such as hepatitis C.
Inleusin: Inleusin is the company's recombinant human interleukin-2, or IL-2, product. Inleusin is indicated for the treatment of renal cell carcinoma, the most common form of kidney cancer, metastatic melanoma, a type of skin cancer, and thoratic fluid build-up caused by cancer and tuberculosis. Inleusin is designed to stimulate the immune system to fight cancer and infectious diseases.
Tietai Iron Sucrose Supplement: Tietai Iron Sucrose Supplement, an intravenously administered prescription drug that is designed to treat anemia associated with iron deficiency, is indicated for patients with end-stage renal disease requiring iron replacement therapy. The company in-licensed five-year exclusive PRC distribution rights for this product from Shenyang Borui Pharmaceutical Company Limited in May 2006.
Baolijin: Baolijin is the company's in-licensed recombinant human granulocyte colony-stimulating factor, or G-CSF, product. G-CSF is a protein that stimulates production of white blood cells. Baolijin is indicated for the treatment of neutropenia, a condition associated with chemotherapy and characterized by low levels of neutrophils, a type of white blood cell important for fighting infections. In August 2006, the company in-licensed PRC distribution rights for Baolijin from Chengdu Biological Institute for a period of five years. Licenses to Tietai Iron Sucrose Supplement and to Baolijin are held by Liaoning Bio-Pharmaceutical Company Limited.
Product candidates
NuPIAO: The company intends to complete in 2008 pre-clinical testing for NuPIAO, its second-generation EPIAO product candidate.
High-Dose EPIAO: The company intends to complete a clinical trial for its 36,000 IU/vial formulation of EPIAO. This product is designed for rapid restoration of hemoglobin to normal levels among cancer patients.
TPIAO for the treatment of ITP: Idiopathic thrombocytopenic purpura, or ITP, is characterized by thrombocytopenia that results in bruising and bleeding that would be severe. The company designed a Phase III clinical trial to study TPIAO for the treatment of ITP.
NuLeusin (IL-2): NuLeusin, the company's second-generation IL-2, is a genetically modified form of IL-2 possessing the same properties as naturally occurring IL-2. It is capable of activating the immune system to recognize and eliminate certain kinds of cancer cells. The company is conducting a multicenter, open-label Phase III clinical study for NuLeusin for the treatment of metastatic melanoma and metastatic renal cell carcinoma.
SSS08 (HPV Vaccine): The company's HPV vaccine candidate targets virus-like particles of HPV-16 and HPV-18.
SSS07 (Rheumatoid arthritis and other autoimmune diseases): SSS07 is the company's anti-TNF monoclonal antibody product candidate that the company intends to develop in collaboration with Epitomics, Inc., a U.S.-based biotechnology company. SSS07 is designed to prevent activating of the inflammation signalling cascade. The company intends to develop its anti-TNF monoclonal antibody product candidate in collaboration with Epitomics, Inc., a U.S.-based biotechnology company.
In March 2006, the company entered into a collaboration agreement with Epitomics, Inc. Under the agreement, the company was also granted the right to manufacture, sell, market and distribute (including distributions by engaging third parties) in China anti-TNF alpha monoclonal antibody therapeutics covered under the intellectual property rights owned by Epitomics.
Sales and Marketing
The company sells its products primarily to distributors, who resell them to healthcare providers, including hospitals and dialysis centers. The company markets its products through distribution agreements with local agents in various developing countries, consisting of Egypt, Pakistan, Thailand, Brazil, Mexico, Trinidad and Tobago, Guatemala and Columbia.
Suppliers
The company's major suppliers include R&D Systems, Inc.; Invitrogen, Inc.; GE Healthcare, a division of GE; and New Brunswick Scientific, Inc. Shanghai Weike Biochemical Reagent Co. Ltd., or Weike, is the company's major raw material supplier of fetal calf serum, or FCS.
Competition
In China, the company's EPIAO competes primarily with Kirin’s ESPO, Roche’s Recormon and ‘Yi Pei’ by Di’ao Group Chengdu Diao Jiuhong Pharmaceutical Factory. Competitors for interleukin-2 in China include Beijing SL Pharmaceutical Co., Ltd. and Beijing Four Rings Biopharmaceutical Co., Ltd. Competitors for Tietai Iron Sucrose Supplement in China include Beijing Novartis Pharmaceutical Co., Ltd. and Nanjing Hencer Pharmaceutical Co., Ltd. and competitors for Baolijin in China include Kirin, Hangzhou Jiuyuan Gene Engineering Co., Ltd. and Qilu Pharmaceutical Co., Ltd.
History
3SBio, Inc. was founded in 1993.
