赛生与首旅集团宣布，DC珠（R）已获得中国食品药品监督

StephenW

Marketwire Get email alerts
SciClone and BTG Announce That DC Bead(R) Has Been Approved by China Food and Drug Administration

Published: Aug 28, 2014 2:00 a.m. ET


FOSTER CITY, CA, Aug 28, 2014 (Marketwired via COMTEX) -- SciClone Pharmaceuticals, Inc. SCLN, -2.36% and its partner BTG plc (BTG), today announced that the China Food and Drug Administration has approved the registration of DC Bead(R) for the embolization of malignant hypervascularized tumors.

BTG and SciClone previously entered into an agreement granting SciClone exclusive licensing and distribution rights to DC Bead(R) in China. Under the agreement, SciClone will purchase product from BTG at a specified price for sale in China. Commercial launch plans are now underway.

Friedhelm Blobel, SciClone Chief Executive Officer commented: "Together with our partner BTG, we will now focus our efforts on preparing for the introduction of the product in the Chinese market. Oncology is a core business focus for SciClone, and our sales team and academic marketing liaisons have established high quality relationships with the medical professionals and institutions that specialize in cancer treatment. We believe DC Bead(R) has the potential to be a valuable addition to SciClone's oncology product portfolio."

Louise Makin, Chief Executive Officer at BTG, said: "Approximately half of the world's liver cancer patients are in China and there is a great interest among Chinese physicians to offer new, differentiated treatment options. Today's news marks an important step toward bringing our first interventional oncology product, DC Bead(R), to the Chinese market where we can help address this need."

DC Bead(R) is a novel treatment for liver cancer which is currently approved in 40 countries worldwide, including Europe. DC Bead(R) is an embolic bead delivered through a minimally invasive, non-surgical procedure to block the blood flow to tumors.

DC Bead(R) is registered in China for the embolization of malignant hypervascularized tumors such as hepatocellular carcinoma ("HCC"), the most common form of primary liver cancer. The majority of people with HCC have cirrhosis, usually from chronic hepatitis B or hepatitis C infection, or chronic alcoholism. Because of the country's high incidence of hepatitis, China accounts for approximately one-half of the world's liver cancer cases. More than 350,000 people dying from primary liver cancer in China annually(1).

DC Bead(R) and/or all indications may not be available in all territories. DC Bead(R) is not currently cleared by the FDA for sale or distribution in the USA.

About BTG BTG is an international specialist healthcare company that is developing and commercializing products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG please visit our website at www.btgplc.com.

About SciClone SciClone Pharmaceuticals is a revenue-generating, specialty pharmaceutical company with a substantial commercial business in China and a product portfolio spanning major therapeutic markets including oncology, infectious diseases and cardiovascular disorders. SciClone's proprietary lead product, ZADAXIN(R) (thymalfasin), is approved in over 30 countries and may be used for the treatment of hepatitis B (HBV), hepatitis C (HCV), and certain cancers, and as a vaccine adjuvant, according to the local regulatory approvals. Through its promotion business with pharmaceutical partners, SciClone markets multiple branded products in China which are therapeutically differentiated. The Company has successfully in-licensed products with the potential to become future market leaders and to drive the Company's long-term growth. SciClone is a publicly-held corporation based in Foster City, California, and trades on the NASDAQ Global Select Market under the symbol SCLN. For additional information, please visit www.sciclone.com.

(1)http://www.ncbi.nlm.nih.gov/pubmed/21144900

StephenW

赛生与首旅集团宣布，特区珠（R）已获得中国食品药品监督管理局

发布时间：2014年8月28日上午02点ET


加州福斯特城，2014年8月28日（通过COMTEX Marketwired） - 赛生制药公司SCLN，-2.36％和它的合作伙伴首旅集团公司（BTG）今天宣布，中国食品药品监督管理局已批准直流登记珠（R） - 对恶性hypervascularized瘤的栓塞。

首旅集团和赛生之前签订的协议，给予赛生独家授权和分销权，以直流珠（R）在中国。根据协议，赛生会以特定的价格在中国销售的产品采购来自首旅集团。商业发射计划正在进行中。

弗里德黑尔姆布洛贝尔，赛生公司首席执行官表示：“通过与我们的合作伙伴首旅集团，现在我们将集中力量准备引进中国市场的产品的肿瘤是一个核心的业务重点为赛生，我们的销售团队和学术营销联络员建立了高品质的关系与医疗专业人士和机构，专门从事癌症治疗，相信特区珠（R）已成为一个有价值的除了赛生的肿瘤学产品组合的潜力。“

路易斯·马金，在首旅集团总裁，说：“大约有一半的世界肝癌患者在中国，有中国医生之间的极大的兴趣，以提供新的，差异化的治疗方案今天的消息标志着走向使我们第一个重要步骤。介入肿瘤学产品，直流珠（R）推向中国市场，我们可以帮助解决这个问题。“

DC珠（R）是一种新型的治疗这是目前在40个国家批准了世界各地，包括欧洲肝癌。直流珠（R）是通过一种微创的，非外科手术递送到阻断血液流到肿瘤栓塞珠。

DC珠（R）被登记在中国为恶性hypervascularized肿瘤如肝细胞癌（“肝癌”），原发性肝癌的最常见形式的栓塞。大多数人肝癌有肝硬化，通常慢性乙型肝炎或丙型肝炎病毒感染，或慢性酒精中毒。因为该国的高肝炎的发病率，中国占了大约一半的全球肝癌病例。超过35人的原发性肝癌在中国，每年死于（1）。

DC珠（R）和/或所有的迹象可能无法在所有地区提供。直流珠（R）是目前尚未被FDA批准用于销售或分销在美国。

关于首旅集团首旅是开发和销售针对急症护理，癌症和血管疾病的产品的国际专业医疗保健公司。该公司已经从销售自己的产品销售，并从产品的合作，特许权使用费收入多元化，并正在寻求获得新的项目和产品的开发和销售，以专科医师。有关首旅集团进一步信息，请访问我们的网站www.btgplc.com。

关于赛生制药赛生是创收，专业制药公司，拥有大量的商业在中国的业务和产品组合，涵盖主要治疗市场，包括肿瘤，感染性疾病和心血管疾病。赛生公司专有的领先产品，ZADAXIN（R）（胸腺法新），被批准在30多个国家，并可能被用于乙型肝炎病毒（HBV），丙型肝炎（HCV）和某些癌症的治疗，并作为疫苗佐剂，根据向当地监管部门的批准。通过推进事业与制药合作伙伴，赛生市场多个品牌产品在中国这是治疗上有区别。本公司已成功授权的产品有潜力成为未来市场的领导者，并推动公司的长期增长。赛生是一家总部位于福斯特城，加利福尼亚州公开上市的公司，并根据符号SCLN交易在纳斯达克全球精选市场上市。有关更多信息，请访问www.sciclone.com。

（1）http://www.ncbi.nlm.nih.gov/pubmed/21144900