Munich, Germany / Hangzhou, China, 23 January 2013. WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) today announced that its US subsidiary WILEX Inc., Cambridge, MA, has entered into an exclusive distribution agreement with GeneDiagnostics Inc. for the commercialization of the serum HER-2/neu ELISA test in China. This biomarker test is FDA cleared in the USA, carries the CE mark for the European market, and is currently for Research Use Only in the Chinese market. GeneDiagnostics plans to conduct clinical studies in leading hospitals in China for the IVD clearance through the State Food and Drug Administration in China (SFDA) as part of the terms. GeneDiagnostics is a clinical research and service provider based in Hangzhou, China, and has well-established business relationships with major hospitals. Financial terms of the agreement were not disclosed.
WILEX Inc.和WILEX AG首席执行官Olaf G. Wilhelm教授评论道：“中国市场预计将成为全球医药市场中增长最快的市场之一。因此，我们很高兴能结交GeneDiagnostics这样一位有能力的伙伴，来完成我们的血清HER-2/neu检测的IVD报批，同时在这一关键市场分销这项检测。”
Professor Olaf G. Wilhelm, CEO of WILEX Inc. and WILEX AG, comments: “The Chinese market is expected to be one of the fastest growing pharma markets in the world. Therefore, we are pleased to have in GeneDiagnostics a competent partner to pursue an IVD approval for our serum HER-2/neu test as well as to distribute the test in this key market.”
GeneDiagnostics Inc. 总裁兼首席科学家Mark Han博士说：“据中国卫生部的最新统计数据，每年新发乳腺癌达126,000例。这大致相当于全球新发总数的十分之一，预计该数字还将以4%的年增长率增长。我们期待着将这项HER-2/neu ELISA检测引进中国市场，因为我们相信它能帮助医生向慎重诊断的乳腺癌患者提供靶向治疗。”
“According to the latest statistics from the Chinese Ministry of Health 126,000 new cases of breast cancer were reported each year. This corresponds to roughly one-tenth of the world’s total and is expected to increase by at least 4 percent annually. We look forward to introducing this HER-2/neu ELISA test into the Chinese market as we believe that it can help physicians administer targeted treatments to carefully diagnosed patients with metastatic breast cancer”, said Dr Mark Han, President and Chief Scientist of GeneDiagnostics Inc.
关于HER-2/neu ELISA
血清HER-2/neu检测测量血清HER-2/neu水平，用于转移性乳腺癌(MBC)患者的处治和监测。HER-2（人类表皮生长因子受体2）是一种蛋白质，见于某些类型的癌细胞，尤其是乳腺癌细胞。HER-2/neu蛋白过度表达的MBC患者，其预后可能较差，疾病更具侵袭性。该检测测量HER-2状态的变化，HER-2/neu血清水平升高提示癌症进展，而血清水平降低提示治疗有效。由于HER-2肿瘤状态可能在原发性与转移性乳腺癌之间发生变化，血清HER-2/neu ELISA检测能够帮助监测HER-2/neu水平的这些变化，帮助医生管理新的治疗选择。该检测为实验室测量血清HER-2/neu提供了一种高效、可靠、成本透明的可能性，而无需其他设备。
About HER-2/neu ELISA
The serum HER-2/neu test measures the serum HER-2/neu level for the management and monitoring of patients with metastatic breast cancer (MBC). HER-2 (Human Epidermal Growth Factor Receptor 2) is a protein found on some types of cancer cells, especially breast cancer cells. MBC patients who overexpress the HER-2/neu protein tend to have a worse prognosis and a more aggressive disease. The test measures changes in the HER-2 status with increasing serum levels of HER-2/neu being reflective of cancer progression while decreasing serum levels being reflective of therapy response. As the HER-2 tumour status may change between primary and metastatic breast cancer tumours, the serum HER-2/neu ELISA test can help monitor these changes in HER-2/neu levels and aid doctors in managing new treatment options. This test offers laboratories an efficient, reliable and cost-transparent possibility for the measurement of HER-2/neu in serum with no need of further equipment.
关于GeneDiagnostics Inc.
中国极地基因技术（杭州）有限公司(GeneDiagnostics Inc.)致力于与中国及世界各地的合作伙伴合作研发、分销和提供用于癌症筛查、监测和诊断的诊断产品和服务。公司已与中国领先的大学和医院开展了广泛的合作，引进、推广新款和创新诊断工具和服务，造福于患者。
About GeneDiagnostics Inc.
GeneDiagnostics Inc., China, is engaged in the collaboration of R&D, distribution and provision of diagnostic products and services used for cancer screening, monitoring and diagnosis together with partners in China as well as worldwide. The company has been working with leading universities and hospitals extensively in China in introducing and promoting new and innovative diagnostic tools and services to benefit the patients.
关于WILEX Inc.
WILEX Inc.是德国WILEX AG的全资美国子公司，采用Oncogene Science这一品牌名称生产、推广和销售基于血清的肿瘤蛋白诊断试剂和各类生物标记检测试剂。其产品阵容包括酶联免疫吸附检测(ELISA)和免疫组织化学(IHC)检测。为了达到为世界各地癌症患者的治疗方案提供支持的目的，WILEX Inc.提供用于测量肿瘤基因、生长因子受体(HER-2/neu, EGFr)、蛋白酶和蛋白酶抑制剂(uPA, PAI-1, TIMP-1)以及缺氧标记(CA IX)的生物标记检测试剂。新款CA IX IHC是一种1类IVD检测，除此以外，WILEX Inc.还提供唯一获得FDA批准的测量血清HER-2/neu水平的IVD ELISA，HER-2/neu用于转移性乳腺癌女性患者的处治和监测。WILEX Inc.总部位于美国马萨诸塞州剑桥市，同时提供GMP和ISO认证的生产服务。进一步信息，请访问www.oncogene.com。
About WILEX Inc.
WILEX Inc. is a wholly owned US subsidiary of WILEX AG, Munich, Germany and manufactures, markets and sells serum based oncoprotein diagnostics and various biomarker tests under the brand name Oncogene Science. The product portfolio includes Enzyme-linked ImmunoSorbent Assays (ELISA) and immunohistochemical (IHC) assays. With the aim of supporting treatment regimens for cancer patients worldwide WILEX Inc. offers biomarker tests for measuring oncogenes, growth factor receptors (HER-2/neu, EGFr), proteases and protease inhibitors (uPA, PAI-1, TIMP-1), as well as markers of hypoxia (CA IX). In addition to the new CA IX IHC which is a class 1 IVD test, WILEX Inc. provides the only FDA-cleared IVD ELISA that measures the serum HER-2/neu level for the management and monitoring of patient care for women with metastatic breast cancer. WILEX Inc. is based in Cambridge, MA, USA and also provides GMP and ISO certified manufacturing services. More information is available on www.oncogene.com.
WILEX AG是一家生物制药公司，总部在德国慕尼黑。公司专注于肿瘤学，开发用于各类癌症的针对性检测和靶向治疗的、基于抗体和小分子的诊断和治疗候选产品。WILEX Inc.除了生产、营销生物标记检测试剂以外，其子公司Heidelberg Pharma GmbH还提供临床前合同研究服务和一种抗体药物螯合物(ADC)技术平台。其商业模式包含研究和产品开发以及这些活动的商业化。我们的客户和合作伙伴包括领先的国际性制药公司。WILEX AG在法兰克福证券交易所挂牌上市。ISIN DE0006614720 / WKN 661472 /代码WL6。进一步信息，请访问www.wilex.com。
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the Company develops diagnostic and therapeutic product candidates for the specific detection and targeted treatment of various types of cancer based on antibodies and small molecules. Beside the manufacturing and marketing of the biomarker tests from WILEX Inc. the subsidiary Heidelberg Pharma GmbH offers preclinical contract research services and an antibody drug conjugate (ADC) technology platform. The business model comprises research and product development as well as the commercialisation of its activities. Our customers and partners include leading international pharmaceutical companies. WILEX AG is listed at the Frankfurt Stock Exchange. ISIN DE0006614720 / WKN 661472 / Symbol WL6. More information is available on www.wilex.com.
