MAH program a shot in the arm for pharma industry

The market authorization holder (MAH) program allows startup companies to file for new drug launches without their own manufacturing facilities.
MAH program a shot in the arm for pharma industry

Hutchison MediPharma's research and development facility in the Zhangjiang Hi-Tech Park 

As Shanghai battles on all fronts to become a global innovation center, Zhangjiang, the sci-tech arm of the FTZ, is leveraging the market authorization holder (MAH) program, allowing startup companies 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 to produce drugs in China instead of building their own productions 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. 

Factory lines 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 to oversee operations. Before the MAH scheme, pure research organizations were not allowed to file for drug registration, only companies with legitimate production licenses. Many promising projects had to be sold at an early stage.

Last year, a total of 68 new drug registrations were filed by 43 applicants in Shanghai under the MAH scheme. 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 manufacture now requires advanced production sites and organizations dedicated to specific aspects of the process from the test tube to the factory line. 

Zhangjiang Hi-Tech Park in Pudong New District 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 oversees 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 forward for the implementation of the trial program and has helped pharma companies to grab an idea about how the new scheme works. 

The Zhangjiang High-Tech Park has been pondering over how new systematic improvements could be helpful for R&D companies since a decade ago and how land plots can be better managed and planned.  

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

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 euros manufacturing facility was officially launched in 2017.

The National Medical Products Administration of China, formerly the China Food and Drug Administration, has accepted an application from Chinese pharma firm Beigene for a new lymphoma drug, whose clinical, manufacturing and quality-control corroborating information was provided by Boehringer Ingelheim’s lab in Shanghai. It is expected to be the first biopharma launched under the MAH scheme. Biopharma products usually require stricter quality control and a longer clinical trial process.

By introducing world-class contract manufacturers to the Zhangjiang Park, local R&D institutions can access state-of-the-art production facilities.

Biomedicine companies registered in Zhangjiang recorded 59.3 billion yuan of revenue in the past year, up 7.9 percent. Gross industrial output value went up 10 percent to 29 billion yuan, nearly one third of the total output in the city in 2018.

China aims to become 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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