As a medical technology, CGT (cell and gene therapy) can conduct IITs (investigator-initiated trials) even before the product is approved for market — it only needs to be filed with the hospital's supervising authority, registered on ChiCTR, and approved by the hospital's ethics committee. This creates a regulatory gap. The "Order 818" policy, which took effect May 1 this year, has tightened oversight of this type trials to some extent. Of course, CGTs also can be as drug to file IND applications to NMPA, and conduct registratory study and approved as drugs. For non-medical-technology drugs, however, IITs still require NMPA market approval first — for example, real-world studies exploring expanded indications. Separately, Hainan's Boao Lecheng pilot zone serves as a testing ground, allowing products already approved overseas but not yet approved by the NMPA to be used in designated pilot hospitals after approvals within the zone, enabling real-world studies to be conducted there.

For years I’ve been asking my neuro colleagues why we hadn’t done clinical chemogenetics yet. Most said too pricey small or risky. Yet clearly the tech and the need are there. My take: VCs in the US are too big now — only social media (prev) or AI (now) have the scale they want.

For years I’ve been asking my neuro colleagues why we hadn’t done clinical chemogenetics yet. Most said too pricey small or risky. Yet clearly the tech and the need are there. My take: VCs in the US are too big now — only social media (prev) or AI (now) have the scale they want.

First human trials of designer protein therapies stun US neuroscientists cen.acs.org/biological-chemi… via @cenmag