来源：中国医药保健品进出口商会网站

各企业：

BioVention CN，是一家总部设在苏州工业园区的中国合资公司。近期，该公司成功开发了具有生物相容性的抗血栓药物洗脱冠状动脉支架系统，具备了药物洗脱支架（阿尔法支架）的三个最关键的特性：安全性，有效性和良好的药物释放控制能力。 BioVention公司具备了先进的药物洗脱支架（DES）技术，优秀的管理团队，美国本土模式的开发与生产质量体系，以及能具有新兴活力的介入心脏病学的市场销售和分销渠道。为了能够扩大其业务，在中国和中国以外的一些国家进行市场销售活动，该公司目前正在寻融资、销售等方面的合作。有意向合作的企业可与下方联系人联系：

联系人：袁志法
电话:86-10-8466 3749
邮箱：yuanzhifa@sinopharm.com

项目介绍：
BioVention CN, a joint-venture company based in Suzhou Industrial Park, China, has completed the development of a new biocompatible and thrombo-resistant coronary drug-eluting stent system (Alpha Stent) that addresses the three most critical aspects of a drug-eluting stent (DES) system: safety, efficacy, and deliverability.  BioVention combines advanced DES technologies, management skills, and quality system developed in the US with local manufacturing, sales and distribution channels to address the emerging interventional cardiology markets.

BioVention CN，是一家总部设在苏州工业园区的中国合资公司。近日，该公司成功开发了具有生物相容性的抗血栓药物洗脱冠状动脉支架系统，具备了药物洗脱支架（阿尔法支架）的三个最关键的特性：安全性，有效性和良好的药物释放控制能力。 BioVention公司具备了先进的药物洗脱支架（DES）技术，优秀的管理团队，美国本土模式的开发与生产质量体系，以及能具有新兴活力的介入心脏病学的市场销售和分销渠道。

The company has established its manufacturing facility in Suzhou Industrial Park, China.  It received a Class III manufacturing permit for implantable devices from the China Food and Drug Administration (CFDA) in 2009, a GMP certification by the CFDA in 2013.  Following the successful completion of a large scale clinical trial (ASCENT trial) with a total enrollment in excess of 1,000 patients, Alpha Stent received CFDA product registration/approval in 2015.  With the approval, BioVenton has begun its commercialization process for the Alpha Stent in China.  Alpha Stent is the first DES system that follows the newly established CFDA DES clinical trial guidelines and successfully completed the most expansive and rigorously controlled clinical trial ever conducted in China.  The ASCENT clinical trial includes a randomized controlled trial (>400 patients) and an “Alpha Stent” only registry trial (>600 patients).  The trial results have been outstanding and exceeded all pre-defined clinical end points.  

该公司已在苏州工业园区建立了自己的工厂，并于2009年获得了中国食品药品监督管理局（CFDA）的第III类植入性医疗器械生产许可证，于2013年获得GMP证书。在涉及上千名受试者的大规模临床试验（ASCENT临床试验）宣告成功之后，阿尔法支架的注册申请于2015年获得CFDA批准。获批后，BioVenton公司开始推进了阿尔法支架在中国的商业化进程。阿尔法支架是第一个依据近期颁布的CFDA 药物洗脱支架（DES）临床试验指南，并首次成功完成了最昂贵和严苛临床试验的药物洗脱支架。ASCENT临床试验中设置了对照组（> 400例）和仅使用“阿尔法支架”的试验组（> 600例）。该临床试验结果斐然，并优于所有预期的临床终点。

The product
产品

Alpha Stent is uniquely different from any other “new” or existing DES in China in that it utilizes a highly biocompatible and thrombo-resistant polymer as its drug carrier, combined with a thin strut, advanced cobalt alloy based stent platform, and the “original” anti-restenotic drug sirolimus, to achieve the three critical requirements of DES: safety (low rate of stent thrombosis), efficacy (low rate of target vessel failure), and superior deliverability.  

阿尔法支架与其他任何国内“新型”的，或者现有的药物洗脱支架不同，使用了高度生物相容性和抗血栓特性的聚合物作为它的药物载体，与纤细的支柱结合，利用先进的钴合金作为支架平台，以及现有的抗再狭窄药物西罗莫司，满足了DES的三个关键条件：安全（支架内血栓形成率较低），有效（靶血管失败率较低），和卓越的药物释放控制能力。

In a prospective randomized controlled portion of the ASCENT clinical trial, a total of 407 patients were randomized to either Alpha Stent  or Excel stent (control stent), a sirolimus eluting stent with biodegradable  drug  carrier (JWMS/Biosensors).  At 9 months, the in-segment late loss for Alpha Stent was 0.04 ± 0.27 mm versus 0.08 ± 0.32 mm for Excel Stent (p=0.17).  At 1 year, the target vessel failure (TVF) rate for Alpha Stent was 3.1% vs 6.7% for Excel stent (p=0.0937).  At 2 year, the TVF rate for Alpha Stent was 3.0 %, statistically significantly lower than that for Excel stent 8.9 %.  No stent thrombosis was observed in the Alpha Stent group within 2 years of clinical follow-up.
在前瞻性ASCENT临床试验的随机对照组中，共有407例患者被随机分为阿尔法支架或Excel支架（对照支架组），均使用了可生物降解的JWMS/生物传感器作为药物载体的西罗莫司洗脱支架。 9个月时，阿尔法支架组后期损失了0.04±0.27毫米，Excel支架组损失了0.08±0.32毫米（P=0.17）。 1年时，阿尔法支架组的靶血管失败率（TVF）为3.1％，而Excel支架组为6.7％(P=0.0937）。在第2年，阿尔法支架组的TVF率为3.0％，显著性低于Excel支架组的8.9％。在接下来2年的临床随访中，阿尔法支架组均没有发现支架内血栓形成。

In the prospective registry portion of the ASCENT trial in which 620 patients received Alpha Stent, the ischemia induced target lesion revascularization (i-TLR) rate at 1 year was 0%, the TVF rate was 0.5%.   At 2 years, the i-TLR was 0.2% and TVF 1.4%.  No stent thrombosis was observed in any of the patients within 2 years of clinical follow-up.  

在前瞻性ASCENT临床试验的注册部分，共计620名患者接受了阿尔法支架疗法，缺血引起的靶血管重塑率（I-TLR）在第1年后是0％，靶血管失败率（TVF）为0.5％。2年后，在I-TLR为0.2％，TVF1.4％。在接下来2年的临床随访中，均无支架内血栓形成。

The clinical results thus firmly established Alpha Stent’s safety - 0% stent thrombosis in over 800 patients within 2 years, efficacy – exceedingly low rates of TLR and TVF, and deliverability – favorable ratings on deliverability, track-ability, and withdraw-ability.

临床结果确认了阿尔法支架的安全性 -超过800例患者在2年内的支架内血栓形成率为0％；有效性 - TLR和TVF均显著降低 ； 药物释放控制能力-良好的药物可释放性，可追溯，可撤回。

The Market
市场

The US market for DES has been stable or slightly declining over the past several years.  The future growth is expected to come primarily from emerging countries, especially China.    China’s PCI procedure has been growing at a CAGR of about 24% in the past decade.  The growth drivers include favorable demographic trends, continuing urbanization, increasing disease burdens, the healthy expansion of the overall economy, growth in incomes which allows greater awareness of and access to treatments, and the government’s focus on healthcare as both a social priority and a strategic industry.  Some 454,000 PCI cases were performed in 2013 in China, an increase of 16.9% over the previous year.  DES accounts for 99.7% of the stent usage, representing a market value of approximately $2 billion USD in 2013.  The number of PCI procedures in 2015 is estimated to be at 600,000 cases, corresponding to about 1 million stents.  

过去的几年中，药物洗脱支架在美国的市场对一直保持稳定或稍有回落。未来的增长预计主要依靠新兴发展的国家，特别是中国。在过去十年中，中国的经皮冠状动脉介入治疗术（PCI）的使用率以年复合增长率约为24%的速度增长。增长驱动因素包括有利的人口增长趋势，持续的城市化，疾病治疗的需求增加，伴随整体经济的稳步提升，收入增加后更加注重健康，能接受先进疗法，政府也把医疗健康作为社会发展要务和战略性新兴产业。仅2013年，中国进行了约454,000例PCI术，比去年同期增长16.9％。 药物洗脱支架（DES）占支架使用率的99.7％，相当于2013年的市场价值约二十亿美元。2015中国进行的PCI术预计为600,000例，相当于需要约100万个支架。
The DES market in China has also been shifting drastically in the recent years.  A decade ago, imported DES accounted for nearly 100% of the market share.  But imported stents now only represent 20% of the total market share, 80% of DES used in China are now manufactured domestically.  
近几年，DES在中国的市场已然开始剧变。十年前，进口的DES几乎占了100％的市场份额。但目前，进口支架目前只占中国市场总份额的20％，意味着80%所用的DES是国产的。
There are several locally manufactured drug-eluting stents in China.  Among the manufacturers are Microport, Lepu, JWMS, Sinomed, and others.  Despite the number of contenders offering 1st and “2nd generation DES”, the vast majority of domestically manufactured DES implanted today are still the 1st generation DES, i.e., Microport’s Firebird II, Lepu’s Partner, and JWMS’s Excel stents.  The so called “2nd generation DES” manufactured locally tend to have various issues or concerns associated with stent design, cost-effectiveness, clinical efficacy, quality, etc.
中国已有一些本地药物洗脱支架生产商。例如，Microport, Lepu, JWMS, Sinomed等。尽管竞争者们可提供第一代和所谓的“第二代”DES，但绝大多数可植入的国产DES仍是第一代，即Microport’s Firebird II, Lepu’s Partner, and JWMS’s Excel支架。所谓的国产“第二代DES”往往有对支架设计，成本效益，临床疗效，质量等相关的各种问题或疑虑
Alpha Stent is the true 2nd generation DES that combines the “best-in-class” DES components and has demonstrated the outstanding safety, efficacy, and deliverability in a large scale clinical trial.  It is anticipated that the highly positive clinical outcomes of the Alpha Stent will have a far-reaching impact in the field of drug-eluting stents.  
阿尔法支架是真正的第二代DES，结合了“顶级的”DES组件与已经过临床试验确认的安全性，有效性，以及卓越的药物释放控制能力。由此可预计，具有优异的临床结果的阿尔法支架将对药物洗脱支架领域产生深远影响。
Management
管理

Dr. Li-Chien Hsu is the founder and currently serving in the role of CEO of the company, directing operational and business strategies.  His over 30-year of experience in the cardiovascular medical device industry includes extensive technical and senior managerial responsibilities with Edwards Lifesciences, Baxter Healthcare Corporation, American Hospital Supply Corporation, Bentley Laboratories, and TherOx Inc.  A seasoned management and advisory team with extensive medical device management experience is also in place.  

目前该公司创始人—— Li-Chien Hsu博士（CEO），负责公司经营战略。他拥有在心血管医疗器械领域从业30年的经验，包括在Edwards Lifesciences, Baxter Healthcare Corporation, American Hospital Supply Corporation, Bentley Laboratories, 以及 TherOx公司积累了丰富的医疗设备技术方面和资深管理方面的经验。他具备了管理优秀的具有医疗器械经验的团队和咨询的能力。

In addition, a full operational team, from manufacturing, quality assurance, product development, regulatory affairs, government affairs, financing to sales and marketing, has been established in China.  
此外，一个完整的——从生产制造，质量保证，产品开发，法规事务，政府事务，融资到销售和营销的运营团队，已经在中国成型。

Investment
投资
The company is currently seeking approximately $12 million in financing to expand its operational, sales and marketing activities in China and in selected countries outside China.  It is anticipated that this is the last round of financing before the company enters into financial independence, IPO, or merger and acquisition opportunities.  
为了能够扩大其业务，在中国和中国以外的一些国家进行市场销售活动，该公司目前正在寻求约1200万美金的融资。由此可以预计，这将是该公司进入财务独立、首次公开募股、拥有并购机会状态之前的最后一轮融资。