In China, 2016 is the Year of the Red Fire Monkey – a zodiac personality known for its intelligence, resourceful determination and unpredictability – foretelling 2016 to be an auspicious year of reinvention. US-based PaizaBio wholeheartedly agrees.
PaizaBio is changing the paradigm of global contract manufacturing. The US-based company offers pharmaceutical multinational corporations (MNCs) rapid, low-cost, low-risk entry into China’s sterile injectables market through its China-based contract manufacturing operations (CMO). The idea is not to produce in China for export to the West; rather, PaizaBio’s model enables MNCs to manufacture drugs in China for the Chinese market, but to Western quality and regulatory compliance standards.
Fast track to success
Deliberately planned, PaizaBio’s business model has proven prescient. Beginning on 1 December 2015, the Chinese FDA (CFDA) enacted sweeping regulatory changes to drug innovation and commercialisation policies, designed to accelerate the backlog of drugs awaiting CFDA review while simultaneously fostering a domestic clinical drug development and manufacturing sector, all to international technical and quality standards. A pivotal component of these changes is to increase the types and categories of new foreign innovative drugs that would qualify for the expanded fast track or green drug approval pathway, while opening up the Chinese CMO sector for the first time as a viable option for foreign companies.
These regulatory changes provide a novel approach to how MNCs can expedite the launch of new products, especially injectables, in China. Instead of sourcing and importing from half a world away, MNCs can perform aseptic manufacturing in country, facilitating rapid market entry with the prudent bonus of local customer and regulatory insight.
China’s economic expansion has, predictably, slowed in recent years, from a growth rate of four times Western GDP to under three times Western GDP. However, with a population larger than North America, South America and the EU combined, and an unwavering national policy of broadening healthcare coverage and access to all, the Chinese pharmaceuticals market will grow from the second to the largest market by value within 5-10 years. With the finality of patent expirations, the accelerating onslaught of biosimilars, the certainty of price pressure, and the increase in development costs for a disproportionally specialist target audience with limited patient populations, China’s embrace of global drug development and commercialisation is a well-timed godsend for the global pharmaceutical industry.
For China, in China
PaizaBio stands ready to provide MNCs with an in-country solution for the technically demanding manufacture of sterile injectables, reflected in its mission statement: ‘For China, in China, to Western standards’. The company’s strategic partner, Ausia BioTech, located in Hangzhou, is the established leader of Western-quality aseptic fill-and-finish pharmaceutical manufacturing in China. CMO services include fill-and-finish operations with nine high-speed automated filling lines, affording an annual capacity in excess of 300 million units; laboratory development, testing, analysis and validation; full regulatory support along with packaging; and climate-controlled warehouse and distribution.
PaizaBio has been pivotal in implementing the pharmaceutical industry’s most comprehensive remote manufacturing monitoring system, BAO-Gong. BAO-Gong gives clients a virtual ‘person in the plant’, offering strict control in the real-time monitoring of the production of drugs into final dosage forms via laptop or mobile device, from anywhere in the world. This is coupled with continuous staff training via the Trans-Pacific Aseptic Institute of Training: a China-based training programme unparalleled in the industry. All this ensures that PaizaBio provides a smooth transfer of clients’ products into an operational environment unsurpassed in quality management.
China offers MNCs an unprecedented, well-timed opportunity to participate in what will be the world’s largest drug market. PaizaBio will help Western companies successfully navigate the highly unique, complex commercial market that is China.
