Personalized cancer treatments, cell and gene therapies and regenerative medicine often don’t fit neatly into a traditional drug approval pathway. So China has established a new approval track to give local patients faster access to emerging innovations.
“This is considered a first-in-the-world regulation that gives biomedical technologies an alternative track that they refer to as the tech track,” said Boyang Yang, founder of the global longevity fund Immortal Dragons.
The new policy is aimed at boosting access to advanced therapies for Chinese patients, according to the global law firm Morgan Lewis. But the change could also shake up the licensing landscape for Chinese biotechs and global pharma companies amid a steep rise in dealmaking.
At the same time, the U.S. is growing increasingly nervous about losing its share of the drug development pie. Lawmakers have been pushing back against relations between China-based and U.S. companies with regulations like the Biosecure Act, which is designed to restrict those ties, and now, a new proposal in Congress that would provide oversight to U.S. investments in Chinese companies.
For China, the new regulatory pathway would create “a ‘land domestically first’ option, reducing the pressure for Chinese innovators to license out prematurely,” Morgan Lewis wrote.
