(BW)(GNI) GNI Group公司看到了中国市场对合成骨材料产品的需求，提供新药Gu-Bang(TM)获得稳定营收

BIOWIRE2K 美国商业新闻2006年10月2日东京消息——亚洲领先的生物制药公司GNI Ltd日前宣布，其中国子公司上海睿星基因技术有限公司（Shanghai Genomics）在赢得北京、上海及广东等地的好几家医院供货合同后，已经扩大了新型人工合成骨生物材料Gu-Bang(TM)的销售。上海睿星基因技术有限公司今年初获得了中国国家食品药品监督管理局（SFDA）有关销售Gu-Bang(TM)的药品批准证书。

Gu-Bang(TM)的结构与成份非常接近人体骨骼的结构与成份，它是一种通过化学合成方法生产的多孔、可生物降解的固体颗粒。在对人体进行移植后，这种多孔材料就会为骨干细胞提供内部连接的微环境，在整个骨愈合过程中促进骨骼生长。这种材料的生物适应性意味着移植是一个缓慢的被再吸收过程，新骨的生长利用了其残余的钙及磷酸盐。这就是说，针对药物控释，Gu-Bang还可作为抗生素、化学疗法剂或消炎药的一种理想载体。

GNI公司董事长、首席执行官兼创始人Christopher Savoie博士说：“GNI公司在中国生产和销售Gu-Bang(TM)的能力表明，公司目前正加紧拓展其再生药领域业务，这种能力也是GNI公司价值链成长及发展过程中所取得的又一个巨大进步。该产品获得中国有关机构的批准证明我们拥有一支杰出、高效的医疗试验团队，我们在获得供货合同方面所取得的最初成功有力地证明了GNI公司进军拥有13亿人口的中国这个呈两位数增长的保健市场的能力。我们将继续努力获得其他许可，并销售其他类似药物，以便在该地区建立强大的供货渠道。”

上海睿星基因技术有限公司首席科技官兼联合创始人Jun Wu博士说：“生产Gu-Bang(TM)利用了先进的纳米技术，这在中国独一无二。这是GNI公司和上海睿星基因技术有限公司在中国市场上的首个医学试验产品。对中国患者来说，Gu-Bang(TM)是一种具有吸引力的安全的选择，随着中国老龄人口的不断增加，预计，有关该产品的骨治疗将有巨大的发展前景。我们将继续开发Gu-Bang(TM)，并全力探索其作为我们其他药品药物控释工具的可能性，目前，我们正在对其他药物进行医疗试验，并着手开发下一代药物载体生物材料。”

临床研究：

Gu-Bang(TM)在被批准进行合乎伦理的医疗试验后，在上海三家主要医院进行了临床试验，Gu-Bang(TM)严格执行了由中国国家食品药品监督管理局制定的药物临床试验质量管理规范（GCP）。这三家医院均获得了国家整形外科产品医疗试验基地认证。此次试验于2005年4月结束，试验结果已由中国国家食品药品监督管理局进行了评估，中国国家食品药品监督管理局于2006年3月6日批准了Gu-Bang(TM)在中国境内的生产和销售。

安全性及药理作用：

Gu-Bang(TM)由钙和磷酸盐这两种基本成份构成，这两种成份原料在过去好几十年里进行了广泛的临床试验。Gu-Bang(TM)是使用一流纳米技术，通过化学合成生产的多孔、能生物降解的固体颗粒。这种材料无毒、无刺激性，具有极好的生物适应性，不含在同种异体移植中所发现的蛋白质、DNA（脱氧核糖核酸）或内毒素，因此避免了移植后产生的异常过敏及排斥反应风险。

基于国际ISO 10993标准及美国材料实验学会（ASTM）的指导方针，有关Gu-Bang(TM)的安全性及生物适应性数据已经完成。这些数据包括长期的安全性及忍受试验数据、急性及有毒细胞毒性试验数据、过敏反应试验数据及遗传毒性试验数据。所有潜伏期研究及临床试验均证明该药物具有极好的生物适应性及安全性。

致编者

关于GNI公司

综合系统药理学领域的领先厂商GNI公司创办于2001年，是一家国际生物制药企业，公司在日本、中国、英国和美国均开展有业务。GNI公司利用合乎伦理的方法，通过复杂的逆向工程技术，成功绘制了基因调控网络图谱。另外，GNI公司还成功开发了把该数据应用于药品开发和发现所需的技术，迄今为止，任何一家企业都没有这项技术。2005年6月，上海睿星基因技术有限公司成为GNI公司的一家子公司，公司在一个把基因发现与药品开发结合在一起的综合药品发现平台上开展业务。2006年4月，GNI公司宣布投资北京大陆药业公司（Beijing Continent Pharmaceutical），并授予该公司在中国的生产及销售权。欲了解更多信息，请访问网站： www.gene-networks.com 。

联系方式：GNI公司 Carol Cherkis, +1-408-572-5567或者 Gavin Anderson & Company Deborah Hayden 或者 John Short, +81-5404-0640

(BW)(GNI) GNI Group Sees Demand for Synthetic Bone Material Product in China

Provision of New Product, Gu-Bang(TM), Secures Stable Revenue

BIOWIRE2K

TOKYO--(BUSINESS WIRE)--Oct. 2, 2006--

GNI Ltd, a leading biopharmaceutical company in Asia, has announced that its China based affiliate Shanghai Genomics has expanded sales of Gu-Bang(TM), a new type of synthetic bone biomaterial, after winning several hospital supply contracts in Beijing, Shanghai and Guandong province. Shanghai Genomics received a Product Registration Certificate from the Chinese State Food and Drug Administration (SFDA) to market Gu-Bang(TM) earlier this year.

The structure and composition of Gu-Bang(TM) closely resembles that of human bone and is chemically synthesized to form porous, biodegradable and rigid granules. Following implantation, the porous material provides an inter-connecting microenvironment for host bone cells to develop during the bone's healing process. The material's biocompatibility means that the implant is gradually reabsorbed and its residual calcium and phosphate is used in the formation of new bone. This means that Gu-Bang can also act as an ideal carrier of antibiotics, chemotherapy agents or anti-inflammatory agents for controlled drug release.

GNI's Chairman, Chief Executive Officer and founder, Dr. Christopher Savoie, said, "The ability to manufacture and market Gu-Bang(TM) in China shows that GNI is pressing ahead with the development of its business in the area of regenerative medicine and is therefore another significant step forward in the growth and development of GNI's value chain. The approval of this product proves that we have an excellent and efficient clinical trial team, while the initial successes we have had in securing supply contracts is evidence of GNI's ability to access China's double-digit-growth healthcare market of 1.3 billion people. We will continue to explore possibilities to license and market other similar products in order to build a strong pipeline in this area."

Dr. Jun Wu, GNI's Chief Scientific Officer and co-founder of Shanghai Genomics, said, "The manufacture of Gu-Bang(TM) utilizes advanced nanotechnology, which is unique in China. This is GNI and Shanghai Genomics' first clinically tested product to reach the market. Gu-Bang(TM) represents an attractive and safe alternative for Chinese patients and, with the increasingly aging population, bone therapy related products are expected to have considerable growth prospects. We are continuing to develop Gu-Bang(TM) and to fully explore its potential as a controlled drug releasing tool for our other drugs that are currently undergoing clinical trials and we have already begun developing next generation drug-loaded biomaterial."

Clinical studies:

After obtaining ethical and clinical trials approval, clinical testing of Gu-Bang(TM) was conducted in three major hospitals in Shanghai, strictly adhering to Good Clinical Practice (GCP) guidelines set by the Chinese SFDA. All three hospitals are certified as national clinical trial bases for orthopedic products. The trial was completed in April 2005, and the results were evaluated by the Chinese SFDA, which approved the manufacturing and distribution of Gu-Bang(TM) in China on 6 March 2006.

Safety and pharmacological profile:

The basic composition of Gu-Bang(TM) is made up of calcium and phosphate, both materials that have undergone extensive clinical testing spanning several decades. Using state-of-art nanotechnology,Gu-Bang(TM) is chemically synthesized to create porous, biodegradable and rigid granules. The material, which is non-toxic, non-irritant and has excellent biocompatibility, does not contain proteins, DNA or endotoxins found in allografts, thus avoiding the risk of abnormal allergic and immunologic reactions following implantation.

Safety and biocompatibility data for Gu-Bang(TM) has been generated based on the international ISO 10993 standard and American Society for Testing and Materials (ASTM) guidelines. These include long-term safety and tolerance tests, acute and toxic cellular toxicity tests, allergic reaction tests and genetic toxicity tests. Al