SHANGHAI, China--(BUSINE WIRE)--Nov. 17, 2005--

Shanghai Sunway Biotech Co. Ltd. a ounced today that the Chinese State Food and Drug Administration (SFDA) has a roved H101, an oncolytic adenovirus, to be used in combination with chemotherapy as a treatment for patients with late stage refractory Nasopharyngeal cancer, a type of head and neck cancer prevalent in China. This marks the first oncolytic viral therapy a roved by any regulatory agency in the world.

来源：中国产业经济信息网

H101 is a modified adenovirus, a type of common cold virus found in most people. The deletion of an E1B-55kd segment in the virus results in its ability to selectively replicate in and kill tumor cells, while leaving normal cells unaffected. The therapy has a very good safety profile -- for most patients the main side effect is fever. The SFDA a roval is based on a multi-center, randomized parallel-group study comparing 5-fluorouracil and ci latin-based chemotherapy with and without H101. The H101 study group demo trated a 27% increase in the number of patients who had complete or partial tumor size reduction compared to the control group.

\"We welcome the SFDA\'s a roval of H101, and we are pleased that cancer patients in China can now benefit from this i ovative treatment,\" said Fang Hu, M.D., Sunway\'s president and chief executive officer. \"Moving forward, we will continue the clinical trials to test for H101\'s additional indicatio including non-small cell lung cancer. At the same time, we are preparing to take the therapy to the world market. Sunway is well-positioned to reach this goal because of its exclusive worldwide rights to oncolytic adenoviral therapy, the clinical succe of H101 in China, and the initial trial results of

Onyx-015 in the United States.\"

The concept of an oncolytic virus was first developed in a similar adenovirus called Onyx-015 by Dr. Frank McCormick, the founder of Onyx Pharmaceuticals. Sunway acquired from Onyx Pharmaceuticals the worldwide rights to Onyx-015 and six patents covering the use of oncolytic adenovirus for cancer therapy. \"I am a olutely thrilled and delighted,\" said Dr. McCormick. \"I am looking forward to further involvement in future clinical trials in the U.S. and Europe.\"

\"Sunway is making every effort to continue to i ovate, e ecially in regard to the ability of oncolytic virus to di olve tumor and release tumor antigen. Our goal is to realize the promise of a personalized in vivo cancer vaccine,\" Dr. Hu said.

( BW)首个用于头颈部癌的溶瘤病毒疗法获得批准

美国商业新闻2005年11月17日中国上海消息――

上海Sunway生物技术有限公司今天宣布，H101已获中国国家食品药品监督管理局（SFDA）批准。H101是一种溶瘤腺病毒，与化疗相结合用于晚期难治愈的鼻咽癌――中国国内的一种常见头颈癌――的治疗。 这标志着世界上首个溶瘤病毒疗法得到了监管部门批准。

H101是对在大部分人群中常见的普通感冒病毒进行改造后得到的一种腺病毒。 删除该病毒E1B-55kd段后，使得其可以有选择的在瘤细胞中进行复制，由此杀死瘤细胞，同时不影响正常细胞。 该疗法十分安全――对于大部分病人来说，最大的副作用是发烧。 中国国家食品药品监督管理局是在比较了多个临床中心进行的随机分配平行比较组试验，对照在使用和不使用H101的情况下，基于5-氟尿嘧啶以及顺铂的化疗结果而批准这一疗法的。 使用了H101的受测组与比照组相比，全部或部分出现肿瘤体积缩小的病人增加了27％。

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