(Yicai) June 12 -- Shanghai's Pudong New Area is pushing forward the commercialization and export of China’s first Chimeric Antigen Receptor T-Cell immunotherapy product, establishing a regulatory framework for this novel cancer treatment to enter overseas markets.

Cross-departmental approval for CAR T-Cell product exports has been completed, and the first business deal is expected within a month or two, Sun Jing, head of governmental affairs and public relations at JW Therapeutics, which is piloting the exports, said yesterday.

Exporting CAR T-Cell therapy is very different from that of general pharmaceuticals due to tight timing and transport needs. Within 44 hours drugmakers must receive immune cells from a patient overseas and get them to a plant that will make a treatment. They must then ship the treatment in a liquid nitrogen tank at -196-degrees Celsius to a medical center abroad within seven days.

To address the unique export requirements, 12 government departments have worked together on regulatory innovation, with some aspects receiving support from central government ministries, Sun said.

China’s first CAR T-Cell therapy was developed by JW Therapeutics, which researches and develops cellular immunotherapies. Founded in 2016, the Shanghai-based firm’s Carteyva therapy was launched in September 2021 and is approved for the treatment of two kinds of lymphoma.

The central government released a plan in January to implement a comprehensive reform pilot in Pudong New Area, granting it greater autonomy to promote deeper reforms and higher-level opening-up.

Of the 139 tasks in the plan, 67 have been implemented, showing initial success, according to Chen Yanfeng, deputy director of the Shanghai Municipal Development and Reform Commission.

Editors: Dou Shicong, Martin Kadiev