China’s orphan drug exclusivity could bolster market, incentivize development

A law taking effect May 15 will, for the first time, grant orphan drugs in China seven years of market exclusivity and provide two years of exclusivity for pediatric indications. Many crucial implementation details have not yet been released. Depending on how it is put into effect, the law could serve as an incentive for domestic rare disease drug development and make China a more competitive market for global biopharmaceutical companies.

The legislation also codifies China’s accelerated drug approval pathways into national law, placing them on firmer legal footing and reducing regulatory uncertainty for developers targeting unmet medical needs. It embeds into law existing pathways for breakthrough therapies, conditional approvals, and priority review and approval procedures...