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March 20, 2019

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A shot in the arm for pharma industry

As Shanghai works on all fronts to become a global innovation center, Zhangjiang, the sci-tech arm of the free trade zone, is leveraging the market authorization holder program, which allows startups to file for new drug launches without their own manufacturing facilities.

The program enables pharma research and development groups from home and abroad to use local contract manufacturers instead of building their own production lines.

Last September, Hutchison MediPharma received approval from the National Medical Products Administration of China for Fruquintinib capsules, a treatment for colorectal cancer, the first for Shanghai under the MAH scheme.

“The new system speeds up the drug registration process and lowers manufacturing costs,” Wu Zhenping, senior vice president of Hutchison MediPharma, told Shanghai Daily in a recent interview. “More importantly, we can dedicate ourselves to our core business of identifying new compounds and drug candidates without having to build a complete in-house manufacturing team.”

Lower research and manufacturing costs ultimately lower the cost to the patient and shorten the launch time. Eight new drugs are in the research stage and are undergoing clinical trials at Hutchison.

Factories that meet Good Manufacturing Practice standards cost at tens of millions of yuan to set up, to say nothing of the cost of acquiring competent talent. Before the MAH scheme, pure research organizations were not allowed to file for drug registration, only companies with production licenses. Many promising projects had to be sold at an early stage.

Last year, 68 drug registrations were filed by 43 applicants in Shanghai under MAH. Of those, 31 research organizations were based in Zhangjiang. The park administration committee has set up a 50-million-yuan (US$7.44 million) “risk relief fund” to provide a cushion of liability protection.

Drug manufacturing now requires advanced production sites and organizations dedicated to specific aspects of the process from the test tube to the factory.

Zhangjiang High-Tech Park in the Pudong New Area was upgraded into a world-class “science city” covering about 95 square kilometers, according to a blueprint by the city government, and the management authorities also oversee the construction and development of the free trade zone since the FTZ areas were expanded at the end of 2014.

Since 2016, the Shanghai Food and Drug Administration has been pushing the implementation of the trial program and has helped pharma companies gain an idea about how the new scheme works.

The Zhangjiang High-Tech Park has been looking at how new systematic improvements could help R&D companies for a decade and how land can be better managed and planned.

Germany’s Boehringer Ingelheim was the first pharmaceutical company to set up a contract manufacturing facility for biomedicine in China, in a joint venture with Shanghai Zhangjiang Biotech and Pharmaceutical Base Development Co Ltd, long before the official launch of MAH.

The company adopted advanced technology, such as single-use technology and continuous manufacturing, in its Shanghai site ahead of three other sites in the United States and Europe. The first phase of Boehringer Ingelheim’s 70-million-euro (US$79.50) manufacturing facility was officially launched in 2017.

Biomedicine companies registered in Zhangjiang recorded 59.3 billion yuan of revenue lasy year, up 7.9 percent. Gross industrial output rose 10 percent to 29 billion yuan, nearly a third of the city’s total 2018 output. China aims to be an “innovation nation” by 2020, an international leader in innovation by 2030 and a world powerhouse in scientific and technological innovation by 2050.


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