New policy opens China biotechnology sector

Published on: October 14th, 2024

In a recent move to foster innovation and high-quality development within China’s medical sector, Ministry of Commerce and National Health Commission of China issued a Notice of Launching a Pilot Program of Expanding the Opening of the Medical Field in 6th Sep 2024.

Historically, “development and application of human stem cells, gene diagnosis and treatment technologies”  is listed as prohibited areas for foreign investment in the “Catalogue for the Guideline of Foreign Investment Industries (2007 revision)” . Due to its overly broad content and lack of detailed definitions and explanations, it has become a major barrier for foreign investment and international collaboration in the cell and gene therapy industry.

This Notice now allows foreign-invested enterprises to engage in the development and application of human stem cell, gene diagnosis and therapy technology in the four major free trade zones, namely Beijing Pilot Free Trade Zone, Shanghai Pilot Free Trade Zone, Guangdong Pilot Free Trade Zone, and Hainan Free Trade Port. All such products registered and approved can be marketed throughout China.

This recent policy announcement marks a significant step towards an open and collaborative medical sector in China, with biotechnology at the forefront of this expansion. This move aligns with the global trend of leveraging biotechnology for developing novel treatments and therapies, as evidenced by the rapid development of mRNA vaccines and gene-editing technologies.