CMO project: Seamless connection with the Marketing Authorization Holder program
In November 2015, the State Council was authorized to launch pilot Marketing Authorization Holder program in 10 provinces and municipalities, providing policy breakthrough and legal basis for biopharma Contract Manufacturing.
The Government Work Report delivered at the annual session of the National People's Congress in 2017 showed that China will fully implement its development plans for strategically important emerging industries, and will facilitate technology research and transformation in the biopharma industry in a bid to enlarge and bolster the industrial cluster.
As the key driver to foster technology research and transformation for biopharma manufacturing, biopharma CMO features an innovative model that helps break the "bottleneck" of manufacturing in the original biopharma industry chain to turn it into a "service platform" in a bid to commercialize and maximize the value of drug candidates. In February 2016, Boehringer Ingelheim was selected as one of the first companies to start biopharma Contract Manufacturing in China.
David Preston, President and CEO of Boehringer Ingelheimmainland of China, Hong Kong and Tai Wan, commented, "Biopharma manufacturing is one of our core businesses in China. It is also clear that we cannot work on our own. In this regard, our partnership with Pudong Government, Shanghai FDA and Zhang Jiang Hi-tech Park was critical to establish the new world-class biotech pilot.
The development of research and innovation platforms like this biological plant will help to facilitate rapid drug discovery, rational drug discovery which will help China to produce radical and affordable treatments and cures. The opening today of this BI biotech pilot allows China and Chinese companies to compete on a global level. It also demonstrates our long-term commitment to investing in China."
An accelerator to bolster the competitiveness of China's biopharma sector
"For the biopharma sector in Zhangjiang and even in China, the launch of the Boehringer Ingelheim China Biopharmaceuticals Site today is a milestone event," said Wang Lanzhong, General Manager of Shanghai Zhangjiang Biotech and Pharmaceutical Base Development Co. "The site will help introduce globally recognized production process, technology, standards and experience into China. It will not only help Boehringer Ingelheim undertake and explore more contract manufacturing projects in China and all over the world, but also foster commercialization of innovation achievement from research-driven companies so as to further shore up the development of China's biopharma industry."
The biopharma industry in China is expected to have broad market prospects and huge potential. In January 2017, the National Development and Reform Commission issued the 13th Five-Year Plan for Development of Biopharmaceutical Industry, which specified the goals and tasks for the next five years. Top priorities include "accelerating innovation, production and industrialization of new medicines," and "constantly upgrading the industrial structure to the middle-to-high end."
Luo Jiali said, "We will team up with more medicine research enterprises and institutions in China to promote clinical research and market debut of innovative products. We will also leverage our advanced global network, manufacturing platform and management expertise to help Chinese enterprises bring their bio-medicines into the global markets and bolster their core competitiveness. With all these efforts, we hope to drive upgrading of the overall structure in China's biopharma sector."