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