ShangPharma计划$ 60M上海工厂作为中国看起来缓解审判路径

StephenW

ShangPharma plans $60M Shanghai plant as China looks to ease trial path
      By EJ Lane     
Formerly U.S.-listed ShangPharma has inked a deal to build a $60 million manufacturing plant in the Qidong Biopharma Industrial Zone that includes R&D facilities in the latest expansion among domestic CROs as China spurs hopes for faster regulatory approvals.

The facility aims at commercial-scale operations for biopharmaceuticals. It plans to begin accepting client work at the site in 2018 that will include one 500 liter single-use mammalian cell culture train for clinical phase supply and two 2,000 liter trains for commercial manufacturing, the company said in a release.

The CMO division of ShangPharma, ChemPartner, will handle R&D.

In May, WuXi Biologics said it has begun construction of a $150 million manufacturing facility for its biologics unit, which it lists as being the largest biologics manufacturing facility of any kind in China.

China's contract research organization (CRO) industry will reach RMB83.2 billion ($13.6 billion) by 2018, from RMB42.6 billion in 2014, as favorable policies combine with demand for testing and development, according to a summary report from Research and Markets released in August.

Among domestic companies such as WuXi AppTec ($WX), Hangzhou Tigermed Consulting, Guangzhou Boji Medical Biotechnological, ShangPharma, China Medical Technologies, Asymchem, HD Biosciences and Porton are set to benefit along with multinationals Covance, Parexel ($PRXL), Quintiles ($Q), Catalent ($CTLT), Charles River ($CRL) and PPD.
3SBio CEO Jing Lou

In 2012, ShangPharma and 3SBio moved to delist from the U.S. and go private. However, in June, 3SBio raised $710 million in an initial public offering on the Hong Kong Stock Exchange after it left the Nasdaq in 2013 and went private under a $370 million deal done by a consortium led by CEO Jing Lou and investment firm Citic Private Equity.

CROs in China received word in August that investigational new drug applications for oncology may see a 60-day deadline for a thumbs up, or down, placing the country on a path already followed by Singapore, Taiwan and South Korea in Asia for quick early-stage decisions.

And earlier the same month, China moved to spur drug approvals by accepting multiregion clinical trial processes as part of an effort to clear nearly 20,000 medicine approval requests pending and allow more innovative therapies to reach the market, according to a briefing by the country's State Council.

In 2014, ShangPharma partnered with Catalent to build a 31,000-square-foot plant in Shanghai named Catalent (Shanghai) Clinical Trial Supplies.

- here's the release

StephenW

ShangPharma计划$ 60M上海工厂作为中国看起来缓解审判路径
  通过EJ巷
以前在美国上市的ShangPharma已经签署了一项协议，以建立在包括研发设施，国内CRO公司中的最新扩张为中国马刺希望更快地监管机构的批准启东生物医药工业园$ 600万个制造业工厂。

该设施旨在为生物医药商业规模经营。它计划开始接受客户工作的网站在2018年，这将包括一个500升单用哺乳动物细胞培养火车临床相供电和两个2000升列车用于商业生产，该公司在一份声明中说。

ShangPharma，睿智化学研究有限公司，的奇美电子事业部将负责研发。

今年五月，药明康德生物制剂表示，它已开始建设的$ 150万个制造业工厂为它的生物单元，它列出了作为在中国的任何形式的最大的生物制品生产基地。

中国的合同研究组织（CRO）产业规模将达到RMB83.2十亿（$ 13.6十亿），到2018年，从RMB42.6十亿在2014年，随着利好政策结合起来用于测试和开发的需求，据研究与市场的总结报告发布在八月。

在国内企业如药明康德（$ WX），杭州泰格医药咨询公司，广州博济医药生物技术，ShangPharma，中国医疗技术，Asymchem，辉源生物和波顿都设置为与跨国公司科文斯，PAREXEL（$ PRXL），昆泰公司（受益沿$ Q），康泰伦特（$ CTLT），查尔斯河（$ CRL）和PPD。
三生制药首席执行官藏经楼

2012年，ShangPharma和三生制药移动从美国退市和私有化。然而，6月，三生制药在香港证券交易所首次公开招股筹集$器710千万美元后也离开了纳斯达克在2013年和下一个$ 370万的合同所领导的CEO藏经楼和投资公司中信产业投资财团完成去私人。

在中国的CRO公司得到消息八月份的新药临床研究申请，肿瘤可能会看到一个60天期限的竖起大拇指，或向下，将在全国已其次是新加坡，台湾和韩国在亚洲快速的早发的道路上舞台的决定。

而早些时候同月，中国移动通过接受跨地区临床试验流程作为努力的一部分，以促进药品审批清除近2万名医药审批申请悬而未决，让更多的创新疗法，达到了市场，据介绍该国的国务院。

在2014年，ShangPharma与康泰伦特合作，在上海建立一个名为康泰伦特（上海）临床试验提供了一个31,000平方英尺的工厂。