Shenzhen Acts First to Regulate Cell, Gene Therapies in China
Xu Wei
DATE:  Dec 11 2020
/ SOURCE:  Yicai
Shenzhen Acts First to Regulate Cell, Gene Therapies in China Shenzhen Acts First to Regulate Cell, Gene Therapies in China

(Yicai Global) Dec. 11 -- China’s southern tech powerhouse of Shenzhen is poised to become the first authority in China to enact laws to stiffen oversight of cell and gene therapies and better implement development strategies in the biomedicine field.

The standing committee of the Shenzhen Municipal People’s Congress, the city’s legislative body, held a work conference on the draft legislation on Dec. 4 to solicit opinions from various government departments and experts, according to a Dec. 9 statement.

Shenzhen is allowed to pilot reforms in biomedicine, artificial intelligence, autonomous driving, Big Data, healthcare, information services, individual bankruptcy, and other newly emerging sectors under a new plan China’s cabinet unveiled in October to implement pilot reforms in the city over the next five years.

It was pointed out in the meeting that in addition to the existing experts, suggestions from top-tier biomedical specialists in China or abroad should be widely welcomed to help guide the legislation. The law-enacting processes should also be sped up by carrying out data collection and research work, and, on the basis of the sector’s current situation, a basic regulatory framework should be drafted and continually improved.

Two years ago, He Jiankui, an associate professor at Shenzhen’s Southern University of Science and Technology, shocked the world by announcing the birth of genetically modified twin babies. The genes of one baby had been modified so it was immune to the human immunodeficiency virus, which causes AIDS.

The news also showed that China lacked strict supervision over the sector and did not have relevant laws and regulations. He was subsequently sentenced to three years in prison and fined CNY3 million (USD458,000) for illegally carrying out human embryo gene-editing intended for reproduction, a court in Shenzhen said at the end of last year.

Still, China has become a fertile ground for the development of cell and gene therapies worldwide, with more than 1,000 clinical trials conducted or under way between 2017 and 2019. The government granted thousands of patents, the second most in the world, during the period, according to a report by accounting firm Deloitte Touche Tohmatsu.

Shenzhen is suited to taking the legislative lead in the area. The development of the city’s biomedical industry started early, and in 2005 it was named by the National Development and Reform Commission, the country’s top planner, in the first batch of national biopharmaceutical industry bases. In 2018, the value added growth of Shenzhen’s biopharm sector reached 22.3 percent, ranking first among the seven strategic emerging industries.

Shenzhen set up more than 300 innovative vehicles in the biopharm industry last year, with world-leading developments in high-end biomedical engineering, genetic sequencing and bioinformatics analysis technologies. The local industry’s value added was CNY33.8 billion (USD5.2 billion), an annual increase of over 13 percent.

Editor: Peter Thomas

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Keywords:   Regulation,Shenzhen,Gene Therapy,Cell Therapy