Life Sciences Horizons Brochure 2025 - Flipbook - Page 75
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2025 Horizons Life Sciences and Health Care
China strengthens support for CTGT development and products
Recent years have witnessed the rapid growth of
Cell, Tissue and Gene Therapy (CTGT) treatments and
products in China and around the globe. According to
a report by the Center for Drug Evaluation under the
National Medical Products Administration (NMPA) on
20 May 2024, a total of 81 clinical trials for cell and
gene therapy products were registered in 2023, nearly
doubling from 46 clinical trials in 2022. Looking ahead,
this number is anticipated to continue to grow in
2025, with CTGT expected to remain a focal point of
intense interest and development in the coming years.
On 7 September 2024, the NMPA, jointly with other authorities,
issued the “Notice on Carrying Out Pilot Programs to Expand
the Opening-up in the Healthcare Sector,” which permits
foreign-invested companies to engage in human stem cell,
gene diagnostics and therapeutic technology development
and application within free trade zones in Beijing, Shanghai,
Guangdong, and Hainan for product registration
and manufacturing.
Since then, local governments have been progressively rolling
out supportive policies, facilitating the market entry of products
derived from such cutting-edge technologies. For example, on
5 December 2024, the Hainan government issued the policy
“Provisions for Promoting Biomedical New Technologies in the Boao
Lecheng International Medical Tourism Pilot Zone, Hainan Free
Trade Port,” which has taken effect and provides a pathway for
foreign companies or foreign-invested companies in China to
convert biomedical technologies in cell and gene therapies
into clinical applications through collaboration with medical
institution(s) located in the Boao pilot zone, the results of which
may be used as references in clinical trial applications. Qualified
products that have been marketed abroad may be imported and
applied in the Boao pilot zone, from which the real-world data can
be used for drug registration in China.
The Beijing, Shanghai, and Guangdong governments, among
others, have further emphasized their support for qualified
engagement in human stem cell, gene diagnostics, and
therapeutic technology development and application.
Despite these policies, foreign companies still face numerous
challenges in China, including the ever-changing
and increasingly complex legal environment, which particularly
impacts lifecycle management and scientific ethics rules.
Other challenges include competitive pressure from domestic
pharmaceutical companies benefiting from lower prices and
government support.
Moreover, China's escalating trade tensions with major economies
like the U.S. and the EU may add another layer of complexity for
technology transfer and export. Closely monitoring global policy
changes and market dynamics will be essential for maintaining
competitiveness and ensuring sustainable growth in this
promising yet challenging region.
Roy Zou
Partner
Beijing
Lu Zhou
Partner
Beijing
Jessie Xie
Counsel
Beijing
Carol Shao
Associate
Beijing
Olivia Xie
Associate
Beijing
