Deny, Denounce, Debate: China Gene-Edited Babies Awaken Genie In The Bottle

With the birth of the world's first gene-edited babies, Chinese researchers again step into the epicenter of a controversy between the use of cutting-edge technology and calls for the tightening of ethical oversight of such research.

He Jiankui of China Southern University of Science and Technology creates first gene-edited babies • Source: China SUST website

Medical researchers in Southern China have apparently inherited a culture of daring to challenge global norms. In the latest case, Associate Professor He Jiankui of China Southern University of Science and Technology and his team announced on Nov. 26 ahead of a Summit on Human Genome Editing in Hong Kong that they had successfully created gene-edited baby twins, in which the CCR5 gene that allows HIV infections at the cellular level had been removed.

The change could potentially confer some degree of resistance to HIV infection of the genetically modified babies, although some experts...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

More from China

Coping Strategies For China Industry Amid BIOSECURE Overhang

 
• By 

With the US BIOSECURE Act waiting for a Senate vote, there are signs it may be prompting some Chinese firms to look at their operations. In the meantime, two legal experts in China suggest a range of coping strategies for companies that may be deemed "of concern."

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.

China Pilots Scheme To Halve IND Review Time For Innovative Drugs

 

China’s top drug regulator is implementing a pilot program offering shorter review times for IND applications to improve the quality and efficiency of clinical studies and stimulate the country’s innovative drug sector.

$14m Handout Anyone? Shanghai Offers Raft Of New Biopharma Incentives

 
• By 

Shanghai issues a new set of policies and financial incentives designed to support and speed up regulatory and commercial activities in the biopharma sector, in a comprehensive stimulus package for companies based in the major Chinese city.

More from Asia

Easing Market Entry: Japan’s PMDA Allows Approval Filings In English

 
• By 

Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.

Akebia’s Vafseo: Japanese Postmarketing Data, Narrowed Indication Eased Liver Toxicity Worries

 
• By 

The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.

India And Pakistan Boost Transparency In Industry-Doctor Interactions

 
• By 

Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.